Enable America Jobs

General Description:

To lead and manage the operational performance of the Manufacturing QA function, ensuring the successful day to day management of: Batch Release (both clinical and commercial), QA manufacturing shop floor activities, Batch Release Key Performance Indicators (KPIs) and QA objectives, whilst adhering to regulatory compliance and achieving commercial success.

To ensure the efficient and effective day to day running of the QA Manufacturing Department.

Essential Functions of the job :

• Developing and implementing the Quality Assurance Batch Release strategy, to ensure it meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals.

• Acts as the site Release Responsible Person, interacts with EU QPs as needed for European batch release.

• Support QA shop floor activities with resources as needed.

• 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.

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

• Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, BeiGene Global Standards, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.

• Ensuring the 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 GMP, SOPs and Health and Safety policies.

• Ensuring that there is a self-inspection program in place which is communicated to Operations to meet the requirements of cGMP.

• 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 and product release for commercial & clinical products in accordance with GMPs.

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

• Ensuring that the QA batch release function meets or improves key performance indicators (KPIs).

• Managing, motivating, coaching and mentoring direct reports, to higher levels of management capability.

• Undertaking any other duties for any department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.

Core Competencies, Knowledge, and Skill Requirements

• Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).

• Minimum of 7 years’ experience in biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility are required.

• Minimum of 5-7 years’ experience in management, with training and knowledge of cGMP and Data Integrity Guidance utilized in a Quality Operation.

• 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.

• Strong leadership/team management skills and experience.

• Credible and confident communicator (written and verbal) at all levels.

• 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

• Production associates, Interacts with all levels of BeiGene manufacturing employees; CMOs.

Supervisory Responsibilities:

• Manage direct reports from QA, batch review and release QA, shop floor QA

Computer Skills:

• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint); knowledge of SAP QM module

Education Required:

Bachelor or above of Science Degree in a related scientific discipline with 8+ years of experience, or MS Degree and 6+ years.

Travel:

• Must be willing to travel approximately 10- 20%

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.