Job Title: Quality Assurance Director
Location: Pennsylvania (On-site)
Salary: $135,000-$155,000 DoE
Our client is a leading CDMO and they are seeking an experienced Quality Assurance Director to drive commercial readiness and ensure that all quality systems are prepared for product launch. You’ll play a critical leadership role in overseeing GMP compliance, building QA frameworks, and ensuring smooth tech transfers from clinical to commercial production.
This is an opportunity to support the SVP of Quality with commercial readiness and eventually building out your own QA Commercial team.
Key Responsibilities:
- Lead QA operations and ensure commercial readiness for all products.
- Develop, implement, and manage quality systems to meet commercial and regulatory requirements.
- Oversee product tech transfer from clinical to commercial phases.
- Manage the preparation and execution of internal and external audits (regulatory and client).
- Ensure compliance with global GMP and regulatory standards (FDA, EMA, etc.).
- Monitor and review batch records, deviations, CAPAs, and change controls to ensure product quality.
- Provide leadership and support to cross-functional teams, including Manufacturing, Supply Chain, and Regulatory.
- Collaborate with clients and internal teams to ensure adherence to timelines and deliverables.
- Lead training and development initiatives for the QA team, ensuring up-to-date knowledge of industry standards.
- Ensure that all documentation, processes, and quality metrics are in place for commercial product release.
- Serve as the primary QA contact for regulatory inspections and client audits.
Job Requirements:
- Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field.
- 10+ years of experience in Quality Assurance within the pharmaceutical or biotech industry, with a focus on commercial manufacturing.
- Strong knowledge of GMP regulations (FDA, EMA, etc.) and commercial manufacturing processes.
- Proven experience leading tech transfers and commercial product launches.
- Excellent problem-solving and risk management skills.
- Strong leadership and communication abilities with the ability to manage cross-functional teams.
- Experience in managing audits and regulatory inspections.
- Demonstrated ability to manage multiple projects and meet deadlines.
This is a fantastic opportunity to take on a leadership role with unlimited growth potential in an organization focused on delivering cutting-edge pharmaceutical solutions.
