MATERIAL AND PRODUCT RELEASE QA, SR MANAGER, US SITE

This position is based in Hopewell, NJ. Manages the operational performance of the Material and Product Release QA function, ensuring the successful day to day management of : Material and Product Release floor activities, material complaints, Batch Release Key processes and QA objectives, whilst adhering to regulatory compliance and achieving commercial success. Assists associates with deviation management and documentation of events. The position also supports other QA duties or QA projects assigned according to business needs.

Ensures the efficient and effective day to day running of the manufacturing QA Team supporting material and product release.

• Essential Functions of the job_
• Developing and implementing the Quality Assurance Release strategy, ensuring the strategy meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals.
• Site expert on ERP software such as SAP
• Reviews and approves product and material specifications.
• Represents Quality Assurance for change controls, projects, continuous innovation, risk assessments, inspection readiness.
• Supports the site Release Responsible Person, interacts with EU QPs as needed for European batch release.
• Support QA floor activities with resources as needed.
• Implementing and monitoring all Quality Assurance floor activities and systems to ensure compliance with FDA / EU regulation, covering cGMP for commercial medicinal products and clinical material for human use.
• Significant participation in regulatory and customer inspections / audits.
• Subject matter expert in GMPs : 21 CFR 210, 211, and 600; knowledgeable in EU Advanced Therapy Medicinal Products (ATMPs).
• Ensuring the development of Material and Product Release QA SOPs (writing, revising, and approving), ensuring regulatory compliance in conjunction with being fit for purpose operationally and commercially.
• Ensuring that all activities are performed in accordance with GMP, SOPs and Health and Safety policies.
• Maintaining an awareness of new and proposed legislation that impacts the business and communicating any changes to the Senior Management Team.
• Ensuring the availability of adequate competent resources to carry out the review and release of materials and product for commercial and clinical products in accordance with cGMPs.
• Ensuring appropriate investigation of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action.
• Ensuring that the QA material and product release function meets or improves key performance indicators (KPIs).
• Supervises, mentors, and coaches direct reports, ensuring compliance and personnel development.
• Undertaking any other duties for any department within the business, which may be requested by the QA Department Head, for which training and / or an explanation has been provided and the scope of work is understood.
• Core Competencies, Knowledge, and Skill Requirements_
• Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
• Required 7 years (B.S. degree) or 5 years (M.S. degree) experience in biological quality assurance, manufacturing, and / or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility are required.
• Expertise in cGMP and Data Integrity Guidance utilized in Quality Operations.
• Demonstrated expertise with ERP systems, such as SAP, and eQMS systems such as Trackwise or Veeva
• Demonstrable track record and skills / experience gained within a similar position(s), at a similar level, specifically pertaining to product and material release for both clinical and commercial products.
• Wide knowledge of products and processes used in the manufacture of unlicensed medicines (clinical materials, mfd. under an IND or IMP. Knowledge of commercial BLA products.
• Strong personal leadership, ability to lead small teams.
• Good communicator (written and verbal) and Strategic thinker, highly customer focused.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a can do attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.
• Highly Desirable : Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP.
• Significant Contacts_
• Interacts with BeiGene employees in Production, Supply Chain, Quality Control, and Warehouse departments frequently.
• Supervisory Responsibilities :
• Supervises direct reports within the Product and Material Release QA Team. Oversight of the product and material release function for the US Site.
• Computer Skills :
• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint); knowledge of SAP QM module preferred, but not required.
• Education Required :
• Bachelor of Science Degree with 7 years of experience, MS with 5 years of experience, (or above) in a related scientific discipline
• Travel :
• Must be willing to travel approximately 10%
• Ability to work on a computer for extended periods of time

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.