Director, Quality Control

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.
• Manufacturing & Quality Control Responsibilities
• 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.
• Quality Oversight & Compliance
• 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.
• Third-Party Oversight
• 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).
• Quality Systems & Continuous Improvement
• 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.
• Regulatory Awareness & Strategic Response
• 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.

Requirements

• Technical Expertise : Strong background in analytical and microbiological method development, validation, transfer, and continuous improvement. Advanced knowledge of GMP testing oversight at CMOs, including laboratory and stability functions.
• Quality Systems : Broad knowledge of risk-based quality systems and key elements such as complaints, change control, APR/PQR, and compliance-related events. Proficient in MS Office, Trackwise, Oracle, Empower, and LIMS.
• Leadership & Strategy : Demonstrated ability

Benefits

Additional Information

Job Description: 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.

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