Manager, QA Manufacturing Compliance, Hopewell Site

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where "BeiGene" or "BeOne" are used to describe the company during this transition period. BeOne 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:

Supports QA investigation activities, ensuring the successful day to day management of: Deviations, root cause

analysis, CAPA's, effectiveness checks, internal and external customer complaints, and related support activities. Works to support QA Key Performance Indicators (KPIs) such as SOP mandated cycle times, on time closure dates, and QA objectives, whilst adhering to regulatory compliance and achieving business success. Work to support both internal GMP audits and Health Authority audits. Supports QA Manufacturing related tasks as assigned by QA Management.to ensure the efficient and effective day to day running of the QA Manufacturing Team.

Essential Functions of the job:

• Ensures the development of Manufacturing QA and Compliance SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being 'fit for purpose' operationally and commercially.
• Supports QA manufacturing shop floor activities with resources as needed.
• Support all QA shop floor and batch systems to ensure compliance with FDA/EU regulations, covering cGMP for commercial medicinal products and clinical material for human use.
• Significant participation in regulatory and customer inspections/audits.
• Significant knowledge in GMPs: CFR 210, 211, and 600; knowledgeable in EU Advanced Therapy Medicinal Products (ATMPs).
• Ensures all activities are performed in accordance with GMPs, 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 that the QA batch release function and Deviation and CAPA processes meet or improve key performance indicators (KPIs).
• Supervises direct reports, to ensure compliance with business procedures and GMP's
• Ensuring appropriate investigation of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action.
• 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 biotechnology, biology, pharmacy, pharmaceutical sciences, chemistry or related scientific field).
• Minimum of 5+ years of experience in biological quality assurance, preferably with advanced knowledge of large molecule manufacturing in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility required.
• Minimum of 2-5 years of experience in people management, knowledge of cGMP and Data Integrity Guidance utilized in a manufacturing operations environment.
• Demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Working knowledge of cGMPs: 21CFR parts 2010 & 211, knowledge of 21CFR600 - Biologics desirable.
• Wide knowledge of products and processes used in the manufacture of unlicensed medicines (clinical materials, mfd. under and IND or IMP). Knowledge of commercial BLA products.
• Strong personal leadership skills and experience, ability to lead small teams.
• Good communicator (written and verbal) and strategic thinker, highly customer focused.
• Strong analytical and problem-solving ability.
• Strong project management skills.
• 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)

Significant Contacts

• Interacts with BeOne employees in all departments; CMOs.

Supervisory Responsibilities:

• Supervises direct reports within the Manufacturing QA and Compliance Team, assists with batch review and release as necessary. QA, Mfg. shop floor QA oversight. Works to ensure that QA Compliance requirements are adequate and meet global standards.

Computer Skills:

• Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).
• Ability to work on a computer for extended periods of time

Other Qualifications:

Education Required:

Bachelor of Science Degree (or above) in a related scientific discipline

Must be able to work in the US without corporate sponsorship.

Travel:

• Ability to travel approximately10%; Requires a valid passport.

Global Competencies

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

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $104,600.00 - $144,600.00 annually
BeOne 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. BeOne 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.