Senior Manager, Quality (GMP/GDP) Compliance

BeiGene

Remote, Europe

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 effect the business of BeiGene.

The Senior Manager GMP/GDP Compliance may also perform internal audits and supports GMP/GDP regulatory inspections.

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

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/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

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.

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.