Senior Manager Quality Operations

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.  

• 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 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.   

• Investigational Systems (Product Complaint, Deviations, CAPAs, OOS).
• Audit Preparedness and Back Room functions.CMC/IND/BLA writing and/or reviewing.
• Represent QOPs on cross-functional projects teams, with Ferring colleagues in multiple geographies.

• Bachelor’s degree in a scientific field (preferably in Microbiology), Advanced degree preferred. 
• Seven or more years of management experience.
• Seven or more years of experience in an FDA regulated manufacturing environment with Quality Assurance experience for medical products.
• At least three of these years in a pharmaceutical and/or biopharmaceutical environment.
• Knowledge of quality regulations and current industry practices. 
• In-depth knowledge of 21 CFR 210 & 211 GMP regulations.
• Preferred knowledge of 21 CFR 600 & 610 GMP regulations.
• Preferred knowledge of 21 CRR 820 and ISO 13485.

At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry’s most impressive people, these are just some of the ways we live our "People First" philosophy.