**Manager, Quality Assurance Compliance
6 days ago
We are seeking a highly skilled Quality Assurance Manager - Supplier Quality to join our team at AmplifyBio. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and compliance of our suppliers and raw materials.
Key Responsibilities- Develop and Implement Supplier Quality Management (SQM) Programs: Create and maintain procedures for supplier qualification, audit planning, and execution to ensure compliance with regulatory requirements.
- Manage Supplier Audits and Qualifications: Conduct regular audits of suppliers to ensure they meet our quality and regulatory standards, and maintain accurate records of audit results and corrective actions.
- Develop and Maintain Quality Agreements: Collaborate with suppliers to develop and maintain quality agreements that meet our regulatory requirements.
- Lead the Material Review Board: Co-manage the Material Review Board with QA Ops leadership to ensure that all materials and suppliers meet our quality and regulatory standards.
- Develop and Report Key Performance Indicators (KPIs): Develop and report KPIs for SQM and audit programs to ensure that our suppliers and raw materials meet our quality and regulatory standards.
- Education: Bachelor's degree or higher in a relevant scientific discipline, such as Bioinformatics, Biology, Biochemistry, or Chemistry.
- Experience: Minimum 6 years of experience in Quality Assurance within a GxP biotechnology or pharmaceutical environment.
- Skills: Documented experience with Supplier Quality Management and Internal/External Auditing, SQM and/or CQA certifications a plus.
- Regulatory Knowledge: Ability to apply GMP regulation and guidelines related to supplier management, such as 21 CFR Part 210 and 211.
- Leadership: Ability to work with minimal supervision and experience managing a team of direct reports.
- Communication: Strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem resolution skills.
AmplifyBio is a leading contract research organization with a comprehensive range of services that span from discovery stage R&D work to manufacturing services for cell, gene, and mRNA-based therapeutics. We are committed to growing and empowering an inclusive community within our company and industry.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.
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