Senior Manager, External QA Validation

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Novato

BioMarin Pharmaceutical

Senior Manager, External QA Validation

Location: Novato, United States

Workstyle: Hybrid

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Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on peopleâ€s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Technical Operations

BioMarinâ€s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarinâ€s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Manager/Sr. Manager, External QA Validation

Role Overview

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The Manager/Sr. Manager, External QA Validation (Technical Quality) serves as a Quality technical lead for process validation and technology transfer activities across BioMarinâ€s external manufacturing network, providing strategic Quality oversight of process validation, cleaning validation, equipment/facility qualification, and other validation activities supporting products manufactured at Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs).

This role is accountable for establishing and maintaining Quality expectations for validation and technology transfer, providing risk-based oversight throughout the transfer and validation lifecycle, and ensuring that external manufacturing processes and associated control strategies are appropriately qualified, validated, and maintained in accordance with BioMarin standards and global regulatory expectations.

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The role partners closely with BioMarinâ€s Technical Development and Services (TDS), Global External Operations (GEO), External Quality Operations, Product Quality Leaders (PQL), and external partners to support successful technology transfers, validation readiness, commercial manufacturing and continuous improvements across the external network.Â

Key Responsibilities

• Serve as the External Quality technical SME for validation and technology transfer, providing Quality leadership and oversight across BioMarinâ€s external manufacturing network.
• Act as the Quality lead for technology transfers of manufacturing processes to CMOs/CDMOs, establishing effective Quality partnerships and supporting planned, predictable, and compliant transfer execution.
• Define and maintain Quality validation expectations and standards for externally manufactured products in alignment BioMarin Global Policies, procedures, industry standards, and regulatory requirements.
• Provide Quality oversight of validation lifecycle activities, including process validation/PPQ, cleaning validation, equipment and facility qualification, and other GMP validation activities.
• Review and approve validation strategies, Validation Master Plans, protocols, reports, risk assessments, and other GMP documentation with the roleâ€s accountability.
• Assess validation and technology transfer risks, identify gaps, recommend appropriate mitigation strategies, and escalate significant risks to Technology Transfer Lead and Quality leadership.
• Provide Quality oversight of technology transfer readiness, including assessment of CMO/CDMO capabilities, validation approaches, manufacturing controls, and GMP readiness prior to execution.
• Partner with Technical Development and Services and Global Quality representatives to ensure appropriate development and implementation of process parameters, in-process controls, specifications, and controls strategies, while maintaining clear functional accountabilities.
• Represent External QA Validation on cross-functional governance and technical forums supporting technology transfer, validation, and external manufacturing.
• Maintain current knowledge of evolving industry standards, regulatory requirements, and validation approaches applicable to biologics and pharmaceutical manufacturing.
• Influence technical and Quality decisions across internal and external organizations without direct authority, building strong partnerships with CMOs/CDMOs and internal stakeholders.
• Other duties as assigned.
• Periodic travel is required.

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Experience/Education

• BS in Engineering, Life Sciences, Pharmaceutical Sciences, Biotechnology, or related technical discipline with at least 8â€"10+ years of relevant experience.
• Significant experience in cGMP-regulated biopharmaceutical environments, with direct experience in Quality Assurance, validation, manufacturing sciences, technical operations, or related functions.
• Demonstrated experience with process validation and validation lifecycle management, including process performance qualification.
• Demonstrated experience supporting technology transfer and manufacturing scale-up in a regulated environment.
• Strong understanding of global regulatory requirements and industry expectations applicable to validation and technology transfer, including relevant FDA, EMA, ICH, and EU GMP requirements.
• Experience with external manufacturing/testing networks (CMOs/CDMOs/CTOs) strongly preferred.
• Strong technical judgement, problem-solving, communication, and stakeholder-management capabilities.
• Demonstrated ability to lead cross-functional teams and influence technical decisions without direct authority.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility Support the organisationâ€s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

Ireland Safety Responsibility

Support the organisationâ€s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

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The salary range for this position is: $121,600 to $167,200. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

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Recruitment Fraud Alert Notice

Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, email Applicant_accommodations@bmrn.com with your request.

This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team â€" please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us at talentacquisition@bmrn.com.

Applicants, please do not use this email address to submit resumes â€" if you do so, you will be redirected to apply through the website.

Click here to review "EEO Is The Law" poster. Click here to review the Pay Transparency Nondiscrimination Statement. Click here to review the Notification of Employee Rights under Federal Labor Laws.

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