Director, Brand PR (Onsite - Boca Raton, FL) BraintrustDirector, Brand PR (Onsite - Boca Raton, FL)San Francisco / Bay Area, CAThe right candidate will bring deep consumer PR and earned media experience, strong people leadership, in-house brand-side experience, and the ability to translate brand priorities into earned media impact across traditional media, culture outlets, social-first news channels, partnerships, experiential moments, product launches, and consumer storytelling. This leader will serve as the day-to-day owner of Brand PR performance across the U.S. portfolio, partnering closely with the SVP of Communications, Brand Marketing leaders, and external agency partners to ensure each brand shows up in culture with relevance, credibility, and consistency.
NewAssociate Medical Director, Medical Safety Jazz PharmaceuticalsAssociate Medical Director, Medical SafetyPalo Alto, CARemote$212,000–$318,000 / yearServe as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products. Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence.
NewExecutive Director, US Medical Affairs, Oncology Solid Tumor Lead Jazz PharmaceuticalsExecutive Director, US Medical Affairs, Oncology Solid Tumor LeadPalo Alto, CARemote$304,000–$456,000 / yearThis role will be the strategic partner for the Oncology Solid Tumor Commercial Lead and collaborate extensively on the design and execution of deployment of field colleagues in support of the therapeutic space, including the design and execution of account-level cross-functional collaboration, quality engagement, field and payer value, evidence strategy and execution, and serve as an SME in compliant medical design. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
NewClinical Resource Director - Healthcare HCA HealthcareClinical Resource Director - HealthcareSan Jose, CA$87,547.20–$148,824Develops relationships and collaborates with facility leadership and staff, physicians, and supply chain to identify, develop and implement continuous quality improvement and cost containment processes for supplies, technology and labor practice. The Clinical Resource Director has a broad enterprise and segment influence and will need to build strategic alliances with Hospital Leadership, Physicians and Supply Chain to execute successfully the clinical supply expense plan.
NewClinical Value Analysis Director HCA HealthcareClinical Value Analysis DirectorSan Jose, CA$87,547.20–$148,824Develops relationships and collaborates with facility leadership and staff, physicians, and supply chain to identify, develop and implement continuous quality improvement and cost containment processes for supplies, technology and labor practice. The Clinical Resource Director has a broad enterprise and segment influence and will need to build strategic alliances with Hospital Leadership, Physicians and Supply Chain to execute successfully the clinical supply expense plan.
NewClinical Resource Director HCA HealthcareClinical Resource DirectorSan Jose, CA$87,547.20–$148,824Develops relationships and collaborates with facility leadership and staff, physicians, and supply chain to identify, develop and implement continuous quality improvement and cost containment processes for supplies, technology and labor practice. The Clinical Resource Director has a broad enterprise and segment influence and will need to build strategic alliances with Hospital Leadership, Physicians and Supply Chain to execute successfully the clinical supply expense plan.
NewMedical Director Ambassador - Hospital Medicine - Traveling - Nationwide VituityMedical Director Ambassador - Hospital Medicine - Traveling - NationwideEmeryville, CAEnsure practice is appropriately represented and demonstrates their value through leadership roles (as applicable) and/or participation with hospital management, medical staff leadership, Medical Executive, Medical Staff and other hospital committees, and within the local community. Strategize and execute a comprehensive annual practice management plan that sets clear goals and objectives, continuously surpassing expectations and delivering value to patients, clients, providers, and the local community.
NewMedical Director - Psychiatry - Mills-Peninsula Medical Center VituityMedical Director - Psychiatry - Mills-Peninsula Medical CenterBurlingame, CASutter Mills-Peninsula Medical Center earned five stars, the highest ranking possible, in the CMS Overall Hospital Quality Star Ratings and an Outstanding Patient Experience Award, placing it among the top 15 percent of hospitals in patient experience. Ensure practice is appropriately represented and demonstrates their value through leadership roles (as applicable) and/or participation with hospital management, medical staff leadership, Medical Executive, Medical Staff and other hospital committees, and within the local community.
NewMedical Director, Medical Safety Jazz PharmaceuticalsMedical Director, Medical SafetyPalo Alto, CARemote$256,000–$384,000 / yearSupport signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management. Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s.
NewSenior Director, Oncology Pharmacology Jazz PharmaceuticalsSenior Director, Oncology PharmacologyPalo Alto, CARemote$232,000–$348,000 / yearPrimary responsibilities of the oncology pharmacology team include establishing efficacy in relevant disease models, demonstrating differentiation relative to relevant comparators, determining PK/PD/efficacy relationships, characterizing mechanisms of action, identifying predictive disease models, indications, and biomarkers, driving preclinical discovery, supporting research and development of Jazz products and drug candidates overall, and designing and executing studies that address clinically relevant priorities. The oncology pharmacology team cross-functional, including participation in matrix teams assigned to specific products that include but are not limited to Clinical Development, Bioanalytical, Toxicology, Clinical Pharmacology, Biomarkers Regulatory Affairs, and Project Management.
NewRegional Director - Anesthesiology - Vituity Practice Management - Emeryville VituityRegional Director - Anesthesiology - Vituity Practice Management - EmeryvilleEmeryville, CACommit to creating and demonstrating inclusivity within Vituity including codesigning, building, and executing strategies, policies, and practices that cultivate equity, inclusion, and fair opportunity for all; demonstrating preparedness to educate, mitigate, coach, and address daily bias and exclusion in partnership with the site leadership. Accountable for ensuring meaningful integration occurs: Identify opportunities for practice line integration to ensure the quality and efficiency of patient care delivery across the acute care continuum; assist with new service line startups; engage regularly with integrated site RDs.
Hospitalist Assistant Medical Director in San Jose, CA TeamHealthHospitalist Assistant Medical Director in San Jose, CASan Jose, CA$145–$159 / hourFull timeWe are seeking an experienced hospitalist with leadership capabilities for Regional Medical Center, a thriving hospitalist program located in the heart of tech mecca, San Jose, California. Competitive Compensation, with an estimated base salary range of $145 to $159 hourly, RVU and quality bonus, plus leadership stipend, with the opportunity to earn additional incentives.
Director of Quality Management Full Time Knight Health Holdings LLCDirector of Quality Management Full TimeSan Leandro, CA$116,000–$147,000 / yearKindred Hospital San Francisco Bay Area is a 99-bed long-term acute care hospital offering the same in-depth care you would receive in a traditional hospital, but for an extended recovery period. Maintains oversight responsibility for all regulatory body surveys, including The Joint Commission (TJC), State Licensing Reviews, and CMS Validation surveys.
Manager/ Director of Quality Assurance CRYSTAL PHARMATECH INCManager/ Director of Quality AssurancePleasanton, CA10+ years of relevant regulatory affairs experience in the bioanalytical CRO or biotechnology/pharmaceutical industry, or a combination of education and experience. Crystal Bio Solutions, a member of Crystal Pharmatech, is a leading biologics analytical organization with operations in the San Francisco Bay Area and New Jersey.
Director of Quality Engineering Netskope IncDirector of Quality EngineeringSanta Clara, CAThis is a high-impact technical leadership role perfect for a hands-on seasoned QE leader who has experience running large quality engineering and tool development organizations. Oversee the long term testing / pre-production environment strategy, ensuring high availability and stability for testing environments used by the entire company.
Senior Director of Quality Assurance Jones Lang LaSalle IncSenior Director of Quality AssuranceOakland, CA$192,000–$210,000 / yearData and Metrics Governance • Understand and support existing key performance indicators (KPIs) and quality metrics to ensure process improvements align with organizational objectives • Assess impact of proposed system and data changes on established governance frameworks and data integrity • Collaborate with data governance teams to evaluate risks and opportunities related to metrics and reporting when implementing process changes • Analyze performance data to identify trends, opportunities, and areas for improvement while maintaining alignment with existing measurement systems. • Model: Operational Excellence Focus • Location: San Francisco Bay Area preferred; other northern California locations considered • Success Metrics • Successful implementation of quality improvement initiatives • Measurable improvements in operational KPIs and process efficiency • Effective stakeholder engagement and cross-functional collaboration • Timely completion of assigned projects and deliverables • Knowledge transfer and capability building within client organization.
Compliance QA Director Exelixis IncCompliance QA DirectorAlameda, CA$190,000–$269,000 / yearActs as the Subject Matter Expert for current global regulatory compliance expectations and proactively reviews changes in regulatory requirements and industry environment that would necessitate future changes and drives completion of impact assessments. Responsible for setting the strategic plan for maintaining organizational inspection readiness across the organization and developing an annual inspection readiness plan, ensures activities are completed, and drives continuous improvement initiatives.
Manager/ Director of Quality Assurance Crystal PharmatechManager/ Director of Quality AssurancePleasanton, CaliforniaOur guiding principle of "getting the crystal form and formulation right the first time for Phase I" not only expedites the progression of your molecule to IND filing and Phase I clinical trials, but also minimizes the necessity for human PK bridging studies. Our key differentiator is our integrated and specialized services, including API solid-state research, crystallization, preformulation, formulation development and manufacturing, clinical supply.
Executive Director of Quality - IP Synopsys IncExecutive Director of Quality - IPSunnyvale, CAThe Team you will be part of: You'll join the IP Group Quality team-a highly collaborative, cross-functional unit focused on driving high-impact quality initiatives across Synopsys' silicon IP portfolio. As a leader, you inspire trust, drive clarity, and champion continuous improvement, enabling Synopsys' IP Group to deliver world-class products with uncompromising quality.
Senior Director, Technical Design & Quality The Gap IncSenior Director, Technical Design & QualitySan Francisco, CALead brand-level fit strategy in close partnership with Design to ensure aesthetic intent is executed with precision, leveraging customer feedback, return insights, and body data to deliver consistent, customer-centric fit across categories and sizes. Partner with Product Development and Sourcing to drive vendor readiness and capability across fit, quality, and product integrity, while advancing cost engineering to deliver optimal cost, trend-right product, and margin alignment.
NewAssociate Director / Senior Manager, Quality Assurance AllakosAssociate Director / Senior Manager, Quality AssuranceRedwood City, CaliforniaAssociate Director / Senior Manager, Quality Assurance Allakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Position Summary: As a member of the Allakos team you will be responsible for quality oversight activities related to Method Validation, Release testing, and Stability for Drug Substance and Drug Product.
Director, Quality Assurance Insitro IncDirector, Quality AssuranceSouth San Francisco, CA$205,000–$218,000 / yearWe work hard to bring together diverse teams-grounded in a wide range of expertise and life experiences-and work even harder to ensure those teams thrive in inclusive, growth-oriented environments supported by equitable company and team practices. These powerful models rely on extensive biological and computational infrastructure and allow insitro to advance novel targets and patient biomarkers, design therapeutics and inform clinical strategy.
Director, Quality Performance / Job Req 956626885 Alameda Alliance for HealthDirector, Quality Performance / Job Req 956626885Alameda, CA$167,440–$251,160 / yearThis role will work cross-functionally to implement quality initiatives to achieve state and national benchmarks for National Committee for Quality Assurance (NCQA) Healthcare Effectiveness Data and Information Set (HEDIS), Centers for Medicare & Medicaid (CMS) Star Ratings, Department of Health Care Services Medi-Cal Managed Care Accountability Set, and Department of Managed Health Care (DMHC) Health Equity and Quality Measure Set. PRINCIPLE RESPONSIBILITIES: Under the general direction of the Senior Director, Quality, the Director, Quality Performance is responsible for developing, coordinating, implementing, and managing the strategic quality performance programs across multiple lines of businesses including Medi-Cal, Dual Eligible Special Needs Program (D-SNP), and Group Care).
NewDirector of Quality Excellence PHILDirector of Quality ExcellenceSan Francisco, CaliforniaRemoteThrough its digital stakeholder experiences, patient access services, market access solutions, and distribution models, pharma manufacturers can deliver affordable and timely therapy access to patients, resulting in more patients staying on their treatment plans longer. Demonstrated ownership of software quality assurance for operational or customer-facing platforms, including test automation, release validation, and partnering with Engineering on defect prevention and resolution.
Director Quality Assurance Imperative CareDirector Quality AssuranceCampbell, CAFull timeWhat You’ll Bring: Bachelor’s degree in engineering or related discipline and a minimum of 10 years of progressive responsibility in quality assurance in a medical device, regulated or robotics setting, plus a minimum of 3 years of prior people management experience; or equivalent combination of education and work experience. As a key leader, this role takes part of strategic conversations and activities that include building a quality infrastructure aimed at transferring operations from concept to manufacturing in collaboration with robotics upper management and consultants.
Associate Director of Global Quality Antheia IncAssociate Director of Global QualityMenlo Park, CARemoteAntheia is seeking an experienced and driven Associate Director of Global Quality to provide hands-on quality leadership across our regulated starting material (RSM) and pharmaceutical active pharmaceutical ingredient (API) operations. Maintain current knowledge of evolving GMP regulations, ICH guidelines, and DEA requirements relevant to controlled substance API and RSM manufacturing; communicate changes and impact assessments to leadership.
Associate Director, GCP QA Mirum PharmaceuticalsAssociate Director, GCP QAFoster City, CaliforniaProvide quality oversite for the GCP/GVP/GLP vendor activities, including internal/external deviations, CAPAs, change controls, and KPIs/KQIs. 10-12 years of experience in the pharmaceutical industry, including 5-10 years in GCP Quality and 5+ years supervising GCP Quality internal staff and/or external consultants.
Associate Director, Analytical Development and Quality Control Aligos Therapeutics IncAssociate Director, Analytical Development and Quality ControlSouth San Francisco, CA$232,000–$271,000 / yearThe Associate Director, Analytical Development and Quality Control will report to the Director & Head of Analytical Development and Quality Control and will be responsible for providing and executing analytical development strategy for small-molecule candidates from early development through late stage, including analytical method development, validation, and transfer; stability programs; and phase-appropriate specifications and analytical control strategies for drug substance (DS), drug product (DP), and related critical materials. Demonstrated track record of managing CROs and CDMOs, preferably on both analytical and bioanalytical projects, in developing methods and quality control strategy for testing of small-molecule drug candidates supporting Phase I to commercial launch.
Associate Director, Quality Data Science Allogene Therapeutics IncAssociate Director, Quality Data ScienceSouth San Francisco, CAIn this role, you will report to the head of Validation and Quality Engineering, and you will be responsible for developing and leading the Quality Data Science/Quality Engineering function to embed the principles and practices of applied statistics, data science and machine learning to further Allogene's efforts in leading the establishment of an allogeneic CAR T platform, and to provide guidance and data driven insights across Allogene's programs. Provide direction and input to project teams utilizing the principles of applied science and statistics to drive strategies for process and analytical understanding and overall product quality control, including approaches for product comparability, process validation, product monitoring, stability trending and lifecycle management/improvement.
NewAssociate Director, Quality Data Science Allogene TherapeuticsAssociate Director, Quality Data ScienceSouth San Francisco, CA$170,000–$210,000 / yearIn this role, you will report to the head of Validation and Quality Engineering, and you will be responsible for developing and leading the Quality Data Science/Quality Engineering function to embed the principles and practices of applied statistics, data science and machine learning to further Allogene’s efforts in leading the establishment of an allogeneic CAR T platform, and to provide guidance and data driven insights across Allogene’s programs. Provide direction and input to project teams utilizing the principles of applied science and statistics to drive strategies for process and analytical understanding and overall product quality control, including approaches for product comparability, process validation, product monitoring, stability trending and lifecycle management/improvement.
Senior Director, Validation and Quality Engineering Allogene Therapeutics IncSenior Director, Validation and Quality EngineeringSouth San Francisco, CA$230,000–$270,000 / yearLed by a management team with significant experience in cell therapy, Allogene is developing a pipeline of "off-the-shelf" CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease.
Senior Director, Validation and Quality Engineering Allogene TherapeuticsSenior Director, Validation and Quality EngineeringSouth San Francisco, CA$230,000–$270,000 / yearLed by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease.
Senior Director, Quality Operations, Service and Repair, Americas Olympus CorpSenior Director, Quality Operations, Service and Repair, AmericasSan Jose, CAIn accordance with published service manuals and product risk documents, ensure implementation of effective service and repair work instructions, process controls, validation, calibration, maintenance, critical component evaluations, quality inspections, and return of product to customers. Proactively lead quality in support of Service and Repair activities across the Americas region, including oversight of regional 3rd party contractors, and work with operations to ensure right first-time quality and compliance with all applicable laws and regulations.
Director, Clinical Quality Assurance CQA Coherus Oncology IncDirector, Clinical Quality Assurance CQARedwood City, CA$190,000–$240,000 / yearThe position will also be responsible for supporting and hosting regulatory inspections and defining and implementing clinical compliance plans to include GCP/GCLP/GVP audits of service providers, CROs, investigator sites, bioanalytical laboratories, and Drug Safety and Pharmacovigilance systems and processes. This role is responsible for ensuring that Coherus plans and systems that govern clinical studies are in compliance with regulatory requirements, industry best practices (ie GCP, GLP, GVP) and company SOPs by working with Quality management, external auditors, and other internal Clinical functions.
Executive Director Quality Assurance, External Manufacturing Vaxcyte IncExecutive Director Quality Assurance, External ManufacturingSan Carlos, CA$300,000–$350,000 / yearSummary: The Executive Director, Quality Assurance, External Manufacturing is responsible for leading the External Manufacturing Quality function and executing the quality strategy across Vaxcyte's global network of Contract Development and Manufacturing Organizations (CDMOs) and external partners. This leader drives a proactive, risk-based quality approach and implements scalable systems, governance, and partnerships to enable operational excellence across the external network, supporting clinical development, BLA readiness, and commercial supply.
Sr. Director, Food Safety & Quality Assurance Kinder'sSr. Director, Food Safety & Quality AssuranceWalnut Creek, CA$200,000–$250,000 / yearThis role plays a critical leadership position in defining and scaling Kinder's quality systems, ensuring that every product delivered to market is safe, compliant, and consistently exceptional in taste and performance. Most of our work happens in the office to spark creativity and community, but we also offer flexibility so team members have the autonomy to work outside the office when needed to support their work-life balance and personal commitments.
Director of Quality Assurance, Clinical Caribou Biosciences, Inc.Director of Quality Assurance, ClinicalBerkeley, CA$220,000–$235,000 / yearProvide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline. The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP, PV, and GLP focused team settings and manage quality related activities related to clinical vendors, investigator sites and regulatory agencies.
Sr Director, Quality Lyten IncSr Director, QualitySan Jose, CA$170,700–$256,100 / yearLyten is leading an industrial revolution through Lyten 3D Graphene, a breakthrough supermaterial unlocking a new generation of products - from lithium-sulfur batteries and energy storage systems to concrete admixtures, lightweight composites, and next-generation sensors that are revolutionizing industries. Doctorate degree in engineering or general sciences AND 12+ years of experience in Quality OR Master's degree in engineering or general sciences AND 14+ years of experience in Quality OR Bachelor's degree in engineering or general sciences AND 16+ years of experience in Quality OR equivalent experience.
Sr Director, Technical Design & Quality - Old Navy The Gap IncSr Director, Technical Design & Quality - Old NavySan Francisco, CALead brand-level fit strategy in close partnership with Design to ensure aesthetic intent is executed with precision, leveraging customer feedback, return insights, and body data to deliver consistent, customer-centric fit across categories and sizes. This leader reports to the Vice President, Technical Design & Quality, Gap Inc. and balances strategic leadership with deep operational execution, translating enterprise vision into measurable brand outcomes while driving day-to-day excellence.
Director, Quality (Clinical) Braveheart BioDirector, Quality (Clinical)San Francisco, CaliforniaThe Director of Quality will serve as a senior quality leader for Braveheart Bio and will be responsible for clinical quality oversight, clinical data integrity, GCP inspection readiness, and support of nonclinical quality activities as needed for our late-stage clinical program in hypertrophic cardiomyopathy (HCM). This leader will partner closely with Clinical Development, Regulatory, Biometrics, PV, Data Management, Medical, Legal and external CRO and vendor partners to ensure effective, inspection-ready clinical quality oversight across all programs.
Senior Director of Technical QA (GMP) Summit TherapeuticsSenior Director of Technical QA (GMP)Palo Alto, CaliforniaHARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. The Senior Director QA will report to the Vice President, Quality Assurance and Regulatory CMC, and provide comprehensive GMP quality oversight across the full chemistry, manufacturing, and controls (CMC) lifecycle for Summit’s oncology pipeline.
Associate Director, GCP QA Mirum Pharmaceuticals IncAssociate Director, GCP QAFoster City, CA$190,000–$205,000 / year10-12 years of experience in the pharmaceutical industry, including 5-10 years in GCP Quality and 5+ years supervising GCP Quality internal staff and/or external consultants. Provide quality oversight for the GCP/GVP/GLP vendor activities, including internal/external deviations, CAPAs, change controls, and KPIs/KQIs.
Director, Quality Systems Align Technology, Inc.Director, Quality SystemsSan Jose, CAOversee the harmonization of quality system processes at various global sites included in the scope of the Invisalign quality system including internal audits, document control, risk management, non-conformance and corrective action handling, inspections, training, and management review. The successful candidate will partner with Align Global QMS leaders to create a quality management infrastructure that is compliant, effective, efficient, agile, and that supports a rapidly growing business with complex and diverse product lines (both hardware and software).
Payer Quality Consultant, Director PricewaterhouseCoopers LLPPayer Quality Consultant, DirectorCAAs a Director, you drive business growth by overseeing multiple projects, cultivating executive-level client relations, and mentoring the future leaders. Examples of the skills, knowledge, and experiences you need to lead and deliver value at this level include but are not limited to: • Lead in line with our values and brand.
Director, Quality Control Oruka Therapeutics IncDirector, Quality ControlMenlo Park, CA$213,000–$240,000 / yearRole Overview: The Director, Quality Control - Combination Products will provide strategic and operational leadership for the Quality Control function supporting late-stage clinical development, analytical testing oversight for clinical drug substance and drug product, process performance qualification (PPQ), regulatory submissions, and commercial launch readiness for monoclonal antibody drug products and combination products, including pre-filled syringes and autoinjectors. Strong knowledge of cGMP regulations and global regulatory expectations, including 21 CFR Parts 210, 211, and 4. Hands-on experience supporting combination products such as pre-filled syringes, autoinjectors, or related delivery systems.
Director External Quality Assurance Ultragenyx Pharmaceutical IncDirector External Quality AssuranceSouth San Francisco, CA$215,600–$266,300 / yearThe Director, CMC QA will report to the Senior Director of CMC QA and be responsible for maintaining strategic responsibility over QA Manufacturing Operations, developing and implementing Ultragenyx CMC Quality approach for assigned programs, and working with colleagues to improve processes utilized to ensure product quality. In this role, in collaboration with key stakeholders in Technical Operations, DIR CMC QA provides quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines.
Director Quality Assurance Imperative Care IncDirector Quality AssuranceCampbell, CA$234,000–$244,000 / yearWhat You'll Bring: Bachelor's degree in engineering or related discipline and a minimum of 10 years of progressive responsibility in quality assurance in a medical device, regulated or robotics setting, plus a minimum of 3 years of prior people management experience; or equivalent combination of education and work experience. As a key leader, this role takes part of strategic conversations and activities that include building a quality infrastructure aimed at transferring operations from concept to manufacturing in collaboration with robotics upper management and consultants.