We are seeking a highly motivated individual to join us as a Director QA, Supplier Quality Management (SQM) for contract manufacturing organizations (CMOs), contract test labs (CTLs), third party logistics (3PLs) (couriers, cryoshippers, remote warehousing) and GMP service providers (e.g. calibration, cleaning). You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy. This individual will work cross functionally and globally to execute and further define the SQM program for CMOs, CTLs, 3PLs and GMP service providers. This role will be a hands-on resource reporting to the Sr. Director, Corporate QA.
Responsibilities (include but are not limited to):
- Responsible for contract manufacturing organizations (CMOs), contract test labs (CTLs), third party logistics (3PLs) (couriers, cryoshippers, remote warehousing) and GMP service providers in Corporate QA, Supplier Quality Management:
- Accountable for the GMP compliance of: audits, QTAs, SCARs, management of supplier initiated changes.
- Manage cross-functionally and globally (Supply Chain, Process Sciences, Manufacturing, Regulatory Affairs, Site QA and Site QC) within Kite and externally to assure compliance and strong relationships with the CMOs, CTLs, 3PLs and service providers.
- Collaborate within SQM team to manage:
- Supplier qualification and specification development processes that use risk-based tools for qualification, classification and performance monitoring.
- Supplier QTA process to assure key quality expectations are reflected in supplier’s operations and updates for changes are managed.
- Supplier initiated change notifications
- Phase-appropriate supplier qualification requirements
- Manage a QA Operations function for disposition, quality issues, change records, protocol review/approvals, etc at CMOs.
- Assure audit schedule and approved supplier list (Oracle Agile and EBS) are maintained.
- Monitor and report on meaningful SQM performance metrics as well as Supplier performance metrics.
- Provide leadership and direction for CMO, lab-related or service provider issues - SCARs, CAPAs, OOS, deviations and change records.
- Collaborate with the Global SQM team to improve processes/share responsibilities as Kite continues to expand globally
- Participate as a representative of SQM for various internal project teams as well as joint committee meetings with suppliers
- Assure all SQM related quality documentation and records are completed thoroughly and timely to maintain compliance
- Lead supplier related investigations as necessary
- Lead, develop and manage staff.
- Support inspection readiness plans and interact with regulatory agencies during inspections on SQM-related matters, as needed.
- Ability to travel up to 20%
- Perform other duties as assigned.
- Bachelor’s degree in biological sciences or related field with minimum of 10 years experience in a pharmaceutical or biologics supplier quality management role; biologics or vaccines experience preferred
- Previous experience managing and developing staff with a minimum of 8 years of experience.
- Experience auditing CMOs, CTLs, calibration, 3PL, sterilization facilities.
- Experience with direct FDA interaction (or other regulatory agencies) required
- ASQ Certified Quality Auditor preferred
- Experience writing, evaluating and closing investigations, CAPAs and change control records.
- In-depth knowledge of and ability to apply GMP in conformance to US, EU and ROW standards
- Willingness to think outside of the box and adapt best practices to this small, but growing environment
- Proficient in MS Word, Excel, and Power Point
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178
Product Quality Assurance
Third Party Logistics