Job Information
BeiGene Senior Director, Commercial Product Quality External Supply in Emeryville, California
General Description:
The job holder is responsible for ensuring the commercial products at CMOs are manufactured, packed, labelled, stored, and transported in a controlled way that is in accordance with regulatory expectations and applicable GMP/GDP quality standards. The role has global responsibility and accountability for commercial product quality for global supply. The job holder leads and develops a staff of Quality professionals to ensure the product quality from CMOs as well as closely work with Distribution and Regional Quality team to oversee commercial product on the end to end supply chain. The job location could be in US, EU or China i.e. should be close to where CMOs are based.
The scope of the role will include but not limited to the following,
Both small molecule and large molecule commercial products
For DS, DP, FP stages at CMO
Including partnering products where BeiGene is the MAH for the market
Managing quality issues and changes at CMOs
Essential Functions of the job:
Lead Small Molecule and Large Molecule commercial product quality team to ensure the quality management process is in place and executed to ensure the 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 product commercial supply e.g. timely batch release
Support GCP inspections in IMP manufacturing perspective
Execute product recalls from commercial supply chain when needed
Perform other tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines
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 commercial GMP batch release
In-depth knowledge of Quality principles, concepts, industry practices and standards
Working Knowledge and experience with US, EU, ICH and/or China GMP regulations as well as international regulations
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).
Other Qualifications: N/A
Travel:
- May travel regionally and intercontinentally estimated up to 30%
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
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