Now Hiring: Supplier Quality Manager - GMP/GCP
Hybrid 3 days/week on-site Local candidates preferred
️ Some domestic/international travel required
Are you a quality-driven professional with a passion for supplier management and regulatory compliance? Join our team as a Supplier Quality Manager and take the lead in managing and enhancing our GMP and GCP Supplier Quality Program.
In this role, you'll oversee qualification and ongoing performance of CMOs, CROs, material suppliers, and service providers-ensuring compliance, mitigating risk, and building trusted partnerships across the supply chain.
What You'll Do:
Maintain and manage the Approved Supplier List
Track supplier performance and qualification activities
Lead the development and execution of Quality Agreements
Drive supplier audits and manage the External Audit Plan
Conduct risk assessments and performance evaluations
Collaborate cross-functionally and with third-party partners to support quality initiatives
Monitor and follow up on audit observations and CAPAs
What You Bring:
- Bachelor's degree in a scientific or technical discipline
- 7+ years in a GMP-regulated pharmaceutical or medical device environment
- Strong knowledge of GxP regulations (21 CFR Parts 11, 210, 211, 820, ISO 13485, ICH, etc.)
- Experience with combination products, sterile, or device-based manufacturing
- Comfortable interacting with regulatory authorities (FDA and global)
- Strong communication, prioritization, and problem-solving skills
Additional Info:
- Local candidates only
- 3-day in-office requirement (hybrid schedule)
- Must be able to travel as needed (domestic/international)
Ready to make an impact? Apply now or connect with me to learn more.