Senior Auditor, Quality (GMP/GDP) Compliance

Senior Auditor, Quality (GMP/GDP) Compliance

Senior Auditor, Quality (GMP/GDP) Compliance

Apply locations Singapore time type Full time posted on Posted 2 Days Ago job requisition id R26024

About us

BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).

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.

Job Description:

General Description:

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

This role supports Inspection Readiness and as such the Senior Manager evaluates external guidelines and regulations, ensuring visibility and awareness of emerging new or changing standards that affect the business of BeiGene.

The Senior Manager GMP/GDP Compliance may also perform internal audits (BeiGene Sites, CMOs, and affiliates) and supports GMP/GDP regulatory inspections.

This position is a hands-on role within the Global Compliance organization with global responsibility and cross-functional influence requiring primarily tactical decision making.

This position is China Remote based.

Essential Functions of the role:

• Execute the external vendor audit program.
• Independently lead/participate in GMP/GDP compliance audits to ensure compliance with existing policies, procedures, standards, regulations, and guidelines and identify gaps or risks.
• Develop, issue and manage audit reports and any associated quality events.
• Conduct and/or support GMP/GDP 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.

Supervisory Responsibilities:

This position may include managing globally located staff; coaching and mentoring of junior staff with training/orientation/qualification and development plan when required.

Qualification Required:

Computer Skills:

• Strong MS Office Skills – Outlook, Word, Excel, and PowerPoint.

Other Qualifications:

• Bachelor’s degree in science or Professional Certifications.
• 10+ years of experience in the pharmaceutical/biotechnology industry.
• 5+ years of GMP/GDP QA experience, 5 of which includes management experience; certification as a quality auditor (CQA) is desirable.
• Knowledge and understanding of the current US and EU 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.
• Excellent written and verbal communication skills, interpersonal skills, and technical writing skills.
• Ability to work at a fast pace and multi-task.
• Working Knowledge and experience with 21CFR210 & 211, ICHQ7, 21CFR600, 21CFR11, 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% travel.

What We Offer To Our Valued Employees

• 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

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 ( https://www.beigene.com/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.