**_General Description:_** Responsible for the design, implementation, and management of Compliance programs for the Hopewell, NJ site. Programs which require development under the QMS include, but are not limited to market action, self-inspection, Health Authority inspection preparation, annual reporting, deviation/complaint/CAPA management, and vendor qualification. This position also includes successful day to day management of these systems post execution to support site clinical and commercial manufacturing. The position may support other QA duties or QA projects assigned according to business needs. Depending on the program supported, this position may include some travel. **_Essential Functions of the job_** **_:_** + Within the Quality Assurance organization, develop and implement Compliance programs for the Hopewell, NJ Site. Ensuring the strategy meets the business requirements and customer deliverables, as well as ensuring the departmental performance against goals. + Determining the appropriate quality KPI’s for clinical and commercial operations. + Working with vendors on as needed for Quality Assurance Agreement authoring and vendor qualification. + Development of all necessary SOPs, ensuring regulatory compliance in conjunction with being appropriate both clinical and commercial operations. + Ensuring that all activities are performed in accordance with GMP, SOPs and Health and Safety policies. + Ensuring the availability of adequate competent resources to execute these QMS programs for commercial and clinical products. + Developing a program for Deviation Management Excellence. + Developing a program for Self-Inspection + Ensuring appropriate investigation of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action. + 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). + Supervises, mentors, and coach’s direct reports, ensuring compliance and personnel development. + Partner with operations to understand raw material, excipients, and component needs for clinical and commercial. + Undertaking any other duties for any department within the business, which may be requested by the QA Senior Leadership. + This is a site-based position. **_Core Competencies, Knowledge, and Skill Requirements_** + Scientific degree (ideally chemistry, biology, biotechnology, pharmaceutical sciences or related). + Minimum of 8 years of experience in quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility are required. + Minimum of 5 years of experience in people management. + Deep knowledge in pharmaceutical QMS. + Demonstrable track record and skills/experience gained within a similar position(s), at a similar level, specifically pertaining to vendor qualification, leading vendor audit programs, and vendor performance management. + Wide knowledge of products and processes used in the manufacture of clinical and commercial manufacturing processes. + Knowledge of both large and small molecules. + 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 Supply Chain, Technical and Operational departments frequently. + Interacts with BeiGene Global Quality. **Supervisory Responsibilities:** + This position includes managing direct reports at the Hopewell, NJ 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 (or above) in a related scientific discipline **Travel:** + Must be willing to travel approximately 10% as needed. + 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.