Senior Director, Clinical Product Quality External Supply

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 job holder is responsible for ensuring the clinical products at COMs are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards with phase appropriate principles. The role has global responsibility and accountability for clinical products quality for clinical trials. The job holder leads and develops a staff of Quality professionals located globally in three quality operation teams of Small Molecule, Large Molecule and IMP Depot Management and Release. The job location could be in US, EU or China.

The scope of the role will include but not limited to the following,

• Both small molecule and large molecule clinical products as well as DS, DP and FP stages from CMOs including batch disposition
• Depots for IMPs including disposition, storage and transportation.
• Managing quality issues and changes at CMOs

Essential Functions of the job:

• Lead Small Molecule, Large Molecule Team and IMP Depot Management and Release team to ensure the quality management process is in place and executed to ensure the clinical product quality is compliant with regulatory requirements and BeiGene standards.

  • Perform batch record review
  • Lead batch related deviation handling in investigation and effective CAPA implementation at CMO
  • Manage change controls
  • Perform batch dispositions 
  • Perform PIP (Person in Plant)
  • Prepare batch related documents e.g. COA
  • Manage temperature excursion from storage and transportation.
• Ensure that quality processes meet Health Authorities expectation and continuously improve it by timely capturing related regulation changes
• Advise and support Quality Agreement content, implementation, and updates.
• Obtain quality performance information at CMOs and drive continuous improvement. Provide the performance metrics information to CMO vendor management team and escalate any quality or compliance issue timely to senior management when needed.
• Closely collaborate with the CMO Vendor Management team on vendor performance monitoring and periodic review, support in audits as required
• Will work cross functionally and collaboratively in BeiGene with e.g. Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU.
• Provide quality support on clinical supply e.g. timely batch release  
• Support GCP inspections in IMP manufacturing perspective
• Execute product recalls from clinical supply chain when needed

Supervisory Responsibilities:  

• Responsible for management, development and co-ordination of a medium sized team of direct staff who are based globally
• With strong cross culture leadership
• Accountable for financial control and for the management of related budgets such as headcount related and travel.
• Ensures sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.
• Build talent pipeline by inspiring and encouraging team members and create a great place to work for their personal development and career success.

Core Competencies, Knowledge, and Skill Requirements

• Bachelor of Science degree or above, in a related scientific discipline/technical filed such as Pharmacy, Biology, Chemistry or Engineering
• Minimum 12 years pharmaceutical or biotechnology industry experience.
• In-depth GMP experience in a quality and manufacturing function.
• Prior experience in GMP batch release in an IMP context.
• In-depth knowledge of Quality principles, concepts, industry practices and standards.
• Working Knowledge and experience with US, EU, ICH and/or China GMP regulations in IMP as well as international regulations in IMP area and able to apply phase appropriate principles 
• Excellent interpersonal skills, including communication, negotiations, facilitations,
• Experience in working in a cross-functional and international environment
• Good presentation skills
• Ability to work independently
• Spoken/Written fluency in English required

Computer Skills:   

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

Travel: 

• May travel regionally and intercontinentally estimated up to 30%