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:

Manages the operational performance of the Manufacturing QA function, ensuring the successful day to day management of:  QA manufacturing shop floor activities, Batch Release Key processes and QA objectives, whilst adhering to regulatory compliance and achieving commercial success. Assists shop floor Mfg. 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.

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).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.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).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 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 RequirementsScientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).Minimum of 5-10 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 2-5 years’ experience in people management, knowledge of cGMP and Data Integrity Guidance utilized in a Quality Operations on the shop floor.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 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 ContactsProduction associates, Interacts with BeiGene manufacturing employees.

Supervisory Responsibilities:

Supervises direct reports within the Manufacturing QA Team, assist with batch review and release, as necessary.  QA, Mfg. shop floor QA oversight.

Education Required:

Bachelor with 7+ years' experience or above of Science Degree in a related scientific discipline with 5+ years of experience.

Computer Skills:

Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint); knowledge of SAP QM module preferred, but not required.

Travel:

Must be willing to travel approximately 10%Ability to work on a computer for extended periods of time

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

Salary Range: $127,900.00 - $172,900.00 annually

BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.