Quality Assurance Manager

Company Description
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Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies._**

**_ In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 58,000 staff across a network of more than 1,000 independent companies in over 54 countries and operating more than 900 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing._**

**_ In 2021, Eurofins generated total revenues of EUR € 6.7 billion, and has been among the best performing stocks in Europe over the past 20 years._**
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- Eurofins CDMO Alphora Inc. provides a fully integrated suite of services to support drug substance and drug product development from the IND enabling development stage, through to phase II & III supply, and commercial validation and manufacturing for niche APIs. In addition to a continuing flow of interesting and challenging projects for global pharmaceutical and biotech companies, Eurofins CDMO Alphora Inc. is committed to growing its state-of-the-art organization, with continued investments in its people, modern facilities, equipment, and instrumentation._

Job Description

**DUTIES AND RESPONSIBILITIES**:

- Manage all day-to-day quality activities within the Drug Product Department related to facility, operations and analytical.
- Ensure that cGMP and Quality Management System requirements are comprehensively fulfilled, in collaboratively supporting company development, clinical and commercial Drug Product fabrication.
- Responsible to ensure that Standard Operating Procedures (SOP’s) are developed, maintained and followed; and these are reflective of current industry regulations and guidance’s, and customer expectations.
- Establish quality metrics related to Drug Product Operations and provide status reports to Quality management. Lead continuous improvement efforts.
- Coach, develop, and mentor the DPO quality team
- Work directly with Engineering to commission any new GMP manufacturing facilities or expansions, as required. Ensure ongoing compliance of DPO facilities through management/oversight of the PM/Calibration program, facility temperature/humidity monitoring, logbook issuance/control, and environmental monitoring.
- As part of the corporate Quality team, represent Drug Product during quality audits by regulatory agencies, clients and internal audits. Manage and/or provide support during the audit process from initial visit through final report close out. Implement any necessary system improvements and corrective actions.
- Lead the timely, comprehensive, and effective investigation of Deviations and OOS’s related to Drug Product Operations to ensure that these result in identification of scientifically sound root cause and robust CAPA’s.
- Responsible for the management of cGMP master documentation required to support Drug Product Operations, including but not limited to: Validation Master Plans, SOP’s, Material Specifications, Master Batch Records, Protocols, etc.
- As part of the corporate Quality team, contribute to the vendor qualification program and ensure all vendors impacting Drug Product Operations are suitably qualified.
- Responsible for the oversight that all cGMP work performed in Drug Product Operations is in compliance with applicable cGMP, including executed batch records, in-process test results, material specification results, and product release test results.
- Responsible for oversight and management of review and release for all analytical data generated within Drug Product Operations; for Drug Product’s, intermediates, IPC’s, raw materials, cleaning validation/verification samples.
- Responsible for oversight of review and approval of analytical method development/validations reports; and analytical/reference standard qualification supporting cGMP Drug Product operations.
- Responsible for oversight of review and approval of stability protocols, data