BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

This position is based in Hopewell, NJ.  Directly manages the QA Manufacturing operations and provides overall Quality support in Drug Product (DP) manufacturing.   Individual is responsible for ensuring the successful day to day management of:  QA manufacturing shop floor activities in DP, inspection readiness activities and GEMBA walks, effective completion of QA objectives and departmental goals, whilst adhering to regulatory compliance and achieving commercial success. Assists shop floor manufacturing associates with deviation management and batch documentation of events. The position also supports other QA duties or QA projects assigned according to business needs.

To ensure the efficient and effective day to day running of the manufacturing QA Team in DP Manufacturing.
 

Essential Functions of the job:

• Develop batch record review strategy to ensure it meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals.

• Supervises QA shop floor activities with resources as needed.

• Assists with implementing and monitoring all Quality Assurance shop floor and batch 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, acting as Scribe on manufacturing area tours.

• Subject matter expert in GMPs: 21 CFR Parts 11, 210, 211, and 600; knowledgeable in EU Advanced Therapy Medicinal Products (ATMPs). 

• Responsible for development of Manufacturing 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 GMPs, SOPs, Global Standards, 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 approval of batch documentation for commercial & clinical products in accordance with GMPs and maintain shop floor presence.

• Ensuring appropriate investigation of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action.

• Supervises direct reports, to ensure compliance with shop floor solutions.

• Undertaking any other duties for any department within the business, which may be requested by Management, 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 5+ years (B.S. degree) or 4+ 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.

• Knowledge of cGMP and Data Integrity Guidance utilized on the shop floor.

• Hands on knowledge of Drug Product manufacturing, packaging, and labeling.  Experience with AQL for finished product.

• Demonstrable track record and skills/experience gained within a similar position(s), at a similar level.

• 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 & efficiently in a busy and demanding environment.

• Self-motivated, with the ability to work proactively using own initiative.  Innovative thinker.

• Committed to learning and development.

• Highly Desirable:  Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook); working knowledge of SAP.