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Quality Assurance Manager
2 months ago
We are seeking a highly skilled Quality Assurance Manager - Supplier Quality to join our team at AmplifyBio. This role will be responsible for the management and execution of the Supplier Quality Management (SQM) and Audit Programs for our New Albany GMP facility.
Key Responsibilities- Develop and/or enhance existing procedures for the selection and management of GMP suppliers, qualification of raw materials, and the execution of the audit program.
- Maintain GMP vendor files, Approved Supplier List (ASL), and conduct periodic assessments to ensure all vendor certification documents, licenses, and statements are current.
- Draft quality technical agreements as required.
- Co-manage the Material Review Board with QA Ops leadership.
- Manage the supplier and internal audit schedule, generate audit plans, and conduct routine quality audits of GMP suppliers/service providers and internal QMS.
- Maintain all audit reports, audit responses, and pertinent corrective actions up to date.
- Conduct follow-ups for internal and supplier audits corrective actions to ensure closure.
- Support QA Operations team to investigate product quality complaints, quality events, incidents, and CAPAs associated with materials or supplier services.
- Develop and report KPIs for SQM and the audit program, assist Supply Chain with KPIs related to material qualification and release.
- Work with QA Training Admin to expand and perform site training for the supplier and audit programs to ensure process alignment.
- Bachelor's degree or higher in a relevant scientific discipline (Bioinformatics, Biology, Biochemistry, Chemistry, or equivalent education and experience).
- Minimum 6 years of experience in Quality within a GxP biotechnology or pharmaceutical environment.
- Documented experience with Supplier Quality Management and Internal/External Auditing.
- SQM and/or CQA certifications are a plus.
- Ability to apply GMP regulation and guidelines related to supplier management, such as 21 CFR Part 210 and 211.
- Ability to work with minimal supervision.
- Experience managing a team of direct reports.
- Strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem resolution skills.
- Ability to apply a risk-based approach related to this role.
- Competitive compensation package.
- Health, dental, and vision insurance.
- Flexible PTO policy.
- Generous paid parental leave.
- Wellness and self-care programs.
- 401(k) match.
- Tuition reimbursement.
- EAP/work-life support system.
- A fun work environment where everyone's voice matters.
