Director, Quality Control
Listed on 2025-12-16
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Quality Assurance - QA/QC
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Healthcare
Data Scientist
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our "people first" philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.
As Director, Quality Control you will be responsible for strategic leadership and oversight of the Quality Control (Analytical and Microbiology) function, including testing at contract labs for drug substance, drug product, and stability programs across commercial and development portfolios. Partner cross-functionally with Pharmaceutical Development, Technical Operations, QA, and CMC Regulatory Affairs to manage method transfers, validations, and data oversight aligned with development and production timelines.
Key responsibilities include vendor oversight, data review, external audits, and management of GMP‑related exceptions (e.g., deviations, CAPAs, OOS/OOT, change-controls).
Oversees designation of critical quality attributes, specification setting, and trending of method and product performance. Provides direction on method transfers and validations, ensuring compliance with regulatory standards and laboratory control requirements.
With Ferring, you will be joining a recognized leader, identified as one of "The World’s Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society’s unmet needs. Ferring US is also Great Places to Work Certified, distinguishing it as one of the best companies to work for in the country.
Responsibilities:Leadership & Strategy
- Provide strategic direction for the Quality Control department to achieve corporate and site-level objectives.
- Build and lead high‑performing team.
- Coach, mentor, and engage team to ensure business goals and development plans are met.
- Oversee manufacturing unit operations, including review and approval of preventive maintenance activities and changes.
- Review and approve issues and investigations related to critical equipment, systems, and utilities.
- Establish and monitor operational metrics to track performance and identify trends.
- Develop and implement short‑ and long‑term plans to ensure corporate and operational compliance with GxP standards.
- Ensure deployment and maintenance of quality processes aligned with regulatory requirements and internal policies.
- Manage planning and budgeting for Quality Control activities.
- Ensure third‑party labs and CMOs comply with quality standards and regulatory expectations to meet product quality attributes.
- Provide QC oversight and approval of cGMP documentation (e.g., change-controls, deviations, CAPAs, SOPs, validation protocols).
- Lead or support QC‑related projects and propose improvements using risk‑based approaches.
- Maintain robust training programs to meet GMP and company requirements.
- Coordinate lab activities and actively participate in regulatory inspections, third‑party audits, and customer audits.
- Monitor emerging regulatory requirements and assess organizational impact.
- Lead remediation efforts for identified gaps and drive continuous improvement initiatives.
- Performs other duties / projects as assigned by the Vice President, Technical Operations.
Education & Experience
Bachelor’s degree in a scientific discipline with 15+ years of experience in pharmaceutical QC operations across development and commercial stages. Alternatively, a Master’s degree with 12+ years or a PhD with 10+ years is acceptable. Small molecule experience is required; biologics experience is highly preferred.
Technical ExpertiseStrong background in analytical and microbiological…
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