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.
Summary: The Sr. Quality Operations Manager is responsible for establishing and maintaining Quality Operations systems to support and provide quality oversight to Manufacturing Operations, Technical Services, Donor Management program, Supply Chain and R&D areas for Clinical and Commercially distributed products. This position is responsible for managing a team to meet product demand requirements and timelines by supporting manufacturing activities including: Donor and Material Hold program, issuance of batch records, in-process Quality review, review of analytical data and batch records and final disposition of product with a complex set of requirements and controls, in accordance with GXP regulations. This role will also work with partners in the development of new Clinical products and programs, with integration activities to support objectives.
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:
Lead the Management of Quality Operations Functions:
Manage the batch record issuance, batch record review, analytical testing review, COA creation, and disposition processes according to product requirements. This may include both Commercial and Phase I, II or III
Manage and maintain the Donor and Material Hold program to ensure Quality oversight and control of donors and materials.
Manage the collection and reporting of records via paper and electronic systems to support timely review and retrieval.
Manage the incoming inspection of raw materials and components.
Manage the COA creation and submission process per product and regulatory requirements.
Establish and maintain the lot release schedule to meet customer and site demands.
Perform technical investigations relating to site deviations, customer complaints and other areas as needed.
Identify, establish and support operational initiatives to improve compliance and right-first-time execution.
Establish metrics and provide trend information for KPI and Metrics reporting systems, including management review and annual product reviews.
Establish the Quality Operations Systems to assure robust design to meet cGMP requirements to prevent or reduce human error, including electronic system design and implementation
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Perform label approval and disposition finished product during shipping operations.
Perform label approval for intermediate, bulk and finished product.
Perform real-time review of labeled, packaged finished product, and perform disposition during shipping operations to support commercial markets and Clinical trials.
Evaluate finished product labeling and batch record requirements for commercial or clinical trial markets in US or global.
Provide support to R&D manufacturing teams from Phase 1 to Phase 3 development to commercialization, according to cGMP. ·
Support creation of Master Batch Records, specifications, COAs, and release criteria.
Manage the process to support batch review, including CMO records, including all testing requirements and Certificate of Analysis program, and perform final disposition.
Support…