Senior Quality Compliance Manager

Quality Compliance Manager

This is a hands-on role within our Global Compliance organization, with global responsibility and cross-functional influence.

The Senior Manager of Quality Compliance supports the External Vendor Audit program to ensure regulatory compliance status of vendors. Ensures that quality and compliance systems follow applicable global regulatory and health authority requirements.

Supports Inspection Readiness by evaluating external guidelines and regulations, ensuring visibility and awareness of emerging new or changing standards that affect the business.

May perform internal audits at BeiGene sites, CMO's, and affiliates, and supports GMP/GDP Health Authority Inspections.

Develops and manages audit reports and any associated quality events.

Maintains and reports GMP/GDP compliance audit trends and metrics.

Develops and/or maintains SOPs and work instructions pertinent to the External Vendor Audit program.

Other duties as assigned.

Responsibilities:

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• Execute the External Vendor Audit program.\
• Independently lead/participate in GMP/GDP compliance audits.\
• Develop, issue and manage audit reports and any associated quality events.\
• Conduct and/or support GMP/GDPP BeiGene Internal audit program.\
• Support GMP/GDP Health Authority Inspections.\
• Maintain and report GMP/GDP compliance audit trends and metrics.\
• Develop and/or maintain SOPs and work instructions pertinent to the External Vendor Audit program.\
• Other duties as assigned.\
• Manage globally located staff.\
• Coach and mentor junior staff with training / orientation / qualification and development plan when required.\
• Ensure quality and compliance systems follow applicable global regulatory and health authority requirements.\
• Support Inspection Readiness by evaluating external guidelines and regulations.\
• Perform internal audits at BeiGene sites, CMO's, and affiliates.\
• Support GMP/GDP Health Authority Inspections.\
• Maintain and report GMP/GDP compliance audit trends and metrics.\
• Develop and/or maintain SOPs and work instructions pertinent to the External Vendor Audit program.\
• Provide guidance on the development and implementation of policies and procedures related to quality and compliance.\
• Identify areas for improvement and implement changes to enhance quality and compliance processes.\
• Develop and maintain relationships with key stakeholders, including senior leadership, functional teams, and vendors.\
• Work closely with cross-functional teams, including Quality Assurance, Manufacturing, Supply Chain, and Regulatory Affairs.\
• Collaborate with internal and external experts to stay up-to-date on industry developments and regulatory requirements.\
• Drive continuous improvement initiatives to enhance quality and compliance performance.\
• Implement and enforce company-wide quality and compliance policies and procedures.\
• Lead and participate in quality and compliance audits, including internal audits and third-party audits.\
• Develop and maintain comprehensive knowledge of regulatory requirements, industry standards, and company policies and procedures.\
• Identify and mitigate risks to ensure compliance with regulatory requirements and company policies.\
• Communicate effectively with stakeholders at all levels, including senior leadership, functional teams, vendors, and customers.\
• Ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.\
• Strong analytical and problem-solving skills, with ability to analyze data and make informed decisions.\
• Excellent written and verbal communication skills, interpersonal skills, and technical writing skills.\
• Ability to work independently and collaboratively as part of a team.\
• Knowledge and understanding of good manufacturing practices (GMP), good distribution practices (GDP), and international conference on harmonization (ICH) guidelines.\
• Understanding of biopharmaceutical manufacturing, analytical chemistry, and chemical manufacturing and business processes.\
• Knowledge and understanding of practical quality assurance in the manufacturing environment, as well as laboratory controls and safety.\
• Working knowledge and experience with 21 CFR 210 & 211, ICH Q7, 21 CFR 600, 21 CFR 11, Eudralex Vol. 4, Chinese GMP 2010, as well as other international regulations pertinent to BeiGene's global market.\
• Working knowledge of applicable ISO Standards.\
• Travel may require up to 50%.\

What We Offer Our Valued Employees:

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• Market competitive compensation package including performance-based annual bonus scheme.\
• Company shares (generous welcome grant and performance-based annual equity plan).\
• In-house and external learning and development opportunities.\
• Fantastic benefits program and keep improving.\
• Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.\
• Join us and Make momentum in your career.\
• BeiGene Global Competencies:\
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  • 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 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.\
  • BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants' personal information in accordance with applicable laws and regulations.\
  • Due to BeiGene's global operation, job applicants' data will be stored overseas with adequate protection.\
  • Besides, job applicants' data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene.\
  • For further details, please refer to BeiGene's Job Applicant Privacy Policy.\
  • If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeiGene's Job Applicant Privacy Policy as well as the relevant privacy terms.\
  • If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeiGene's Job Applicant Privacy Policy as well as the relevant privacy terms.\
  • If you have any concern, please DO NOT provide any resume or other personal information to us.\