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.
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.
The Manager, Production Compliance is responsible for overseeing the investigation deviations within the manufacturing site, the implementation of production CAPAs, inclusive of production standard operating procedures and master batch records. This role ensures investigations are thorough, timely, and compliant with applicable regulations and internal quality standards. The Manager leads a team of Compliance Specialists and partners cross-functionally to identify root causes, implement effective CAPAs, and drive continuous improvement through trend analysis and reporting.
Responsibilities :
Lead, manage, and develop a team of Compliance Specialists responsible for deviations, non-conformances, and manufacturing incidents.
Ensure investigations are completed in a timely manner with appropriate documentation, root cause analysis, and regulatory compliance.
Serve as SME for investigation.
Drive consistent use of root cause analysis tools (e.g., 5 Whys, Fishbone, Fault Tree, etc.).
Oversee implementation of production CAPAs, inclusive of performing effectiveness checks and follow-up activities.
Provide regular reporting on deviation trends and metrics to site leadership.
Identify systemic issues and collaborate with site functions to prevent recurrence.
Serve as lead liaison with QA, QC, Operations, Engineering, and Supply Chain during investigations.
Support regulatory inspections and internal audits by providing investigation records and justifications.
Represent the site’s investigation programs, if applicable
Requirements:
Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
7+ years of experience in GMP manufacturing or QA, with at least 3 years in a compliance or investigations role.
2+ years of people management or team leadership experience.
Strong knowledge of FDA regulations, cGMP, and quality systems.
Experience with TrackWise or similar electronic quality systems preferred.
Skilled in problem solving, root cause analysis, and CAPA design.
Excellent written and verbal communication skills.
Ability to manage multiple priorities in a fast-paced manufacturing environment.
Physical Requirements:
Combination of office work and time on the aseptic manufacturing floor, including warehouse and support areas.
Ability to stand, walk, and sit for extended periods, including during floor investigations, line walkthroughs, and audits.
Ability to bend, stoop, reach, and climb stairs, platforms, or ladders to observe equipment and processes.
Ability to occasionally lift and carry up to 25 lbs (e.g., batch records, samples, small equipment).
Ability to qualify for and wear full cleanroom gowning and to follow cleanroom hygiene rules
Completion of gowning qualification and ongoing aseptic behavior training.
Ability to wear required protective equipment (e.g., safety glasses, hearing protection, safety shoes) and work around cleaning and sanitizing agents and moving equipment, following site safety procedures.
Extended…