Associate Director, Research and Development Quality QMS

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: 

The Associate Director of R&D Quality QMS (GCP Quality Process Management) is responsible for implementing and maintaining a balanced, proactive, and phase appropriate approach to GCP Quality Assurance. This position will be primarily responsible for ensuring research and development activities are conducted in accordance

with applicable regulatory requirements, guidelines, laws and internally established standards and

practices.  Within the R&D Quality QMS team, focus will be split into internal audit, GCP Quality Process management, QMS metrics/QMS optimization, and Significant Quality Event (SQE)/CAPA/ Serious Breach management. 

Essential Functions of the Job:

Manage and oversee R&D Quality activities which include, but are not limited to:

• Oversee Quality activities related to FDA and ROW regulations across therapeutic areas and provide GCP guidance for all phases of drug development
• Help drive implementation of Quality by Design principles
• Chair internal SOP Committee focused on providing support to cross functional teams to review new controlled procedures or procedures requiring substantial cross functional feedback
• Work closely with other team members within the R&D Quality team to identify areas of process development and/or improvement
• Be the assigned R&D Quality reviewer on cross functional procedures that require a functional team delegate
• Delegated GCP Quality release approver for all Quality Docs ensuring controlled procedures released are following applicable regulatory standards, consistent across other internal processes and standards, and that assigned approvers and training assignments are appropriate based on GXP area
• Establish strong partnerships with key business stakeholders, including Clinical Operations, Clinical Development, Regulatory Affairs, Data Management, Biostats, GPS, etc
• Assist in defining metrics and measures for R&D Quality to drive assessments and continuous process improvement
• Support the inspection readiness activities and participate in managing regulatory health authority inspections as needed
• Collaborate with R&D Quality Audit Management, Inspection Management, GVP, GLP, and Quality Excellence teams aligning on identified risks and staff resourcing strategies
• Manage /review trends and report significant investigation / deviation issues and system deficiencies to senior management, as appropriate
• Strong global mindset and knowledge about regulations (specific expertise regulations/ requirements/ culture awareness)
• Promote continuous improvements in quality systems and department infrastructure; assist with creation / revision of appropriate Global Standards, SOPs, WIs

Additional Qualifications:

• Bachelor’s degree with 8+ years; Master’s degree with 6+ years; or PhD/MD/JD/PharmD with 4+ years of R&D quality assurance compliance experience
• Expert knowledge of GCPs particularly FDA, EMA, and ICH requirements
• Familiarity with GVP and 21 CFR Part 11 electronic systems and compliance activities is preferred
• Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors
• Experience in implementing principles for Quality Risk Management (ICH Q9, ICH E6 R2)
• Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
• Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance
• Proven ability in setting strategy for and driving quality process improvement initiatives
• Strong leadership experience and mentoring skills
• Other duties as assigned

Supervisory Responsibilities:  

This position may include managing staff: coaching and mentoring of junior staff with training/orientation/qualification and development plan for new Quality staff when required.  Therefore, it is required to have strong leadership experience and mentoring skills.

Education Required: 

Bachelor’s degree, preferably in Science with 8+ years experience, or MS with 6+ years experience.

Computer Skills:  

• PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Other Qualifi