Associate Director, Commercial Product Quality US Regional Lead, External Supply Quality

BeiGene

3d•$143,400 - $193,400•Hybrid

About The Position

The Associate Director, Commercial Product Quality US Regional Lead in External Supply Quality organization is responsible for ensuring that externally manufactured commercial products are manufactured, packed, labelled, stored and transported in a controlled way at Contract Manufacturing Organizations (CMOs) 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 scope will also include product life cycle management projects. The job holder will support and ensure compliance with applicable international regulations and BeOne quality standards and procedures at CMOs. The scope of the role will include but not be limited to the following: Small molecule and large molecule commercial products in the US for DS, DP and FP, managing quality issues and changes at CMOs, post-approval changes, packaging changes or other life cycle management projects, and clinical supply after commercialization. Team management to ensure the proper level of resource with efficiency.

Requirements

Bachelor of Science degree, in a related scientific discipline/technical field such as Pharmacy, Biology, Chemistry or Engineering.
8+ years of quality pharmaceutical or biotechnology industry experience required.
4+ years management experience.
Responsible for management, development and co-ordination of a medium sized team of direct staff who are based in the US.
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.
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
In-depth GMP experience in a quality and manufacturing function for small molecule and large molecules.
Ability to apply principles of logical and scientific thinking to a wide range of intellectual and practical problems.
Ability to effectively lead teams and manage staff.

Nice To Haves

Master’s degree and 6+ years of experience preferred.

Responsibilities

Lead 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 BeOne standards.
Accountable for BeOne qualified CMO oversight within US including performance management, trend evaluations and remediation as required.
Serve as the primary escalation point for CMO quality managers.
Review and approve change control strategy for CMO notified changes.
Review and approve APQR reports from CMOs manufacturing BeOne product.
Lead batch related deviation handling in investigation and effective CAPA implementation at CMO.
Perform or oversee PIP (Person in Plant).
Oversee inspection management capabilities within the team to ensure successful outcomes for CMO hosted inspections or BeOne hosted inspections eg CMO PAIs, PV inspections.
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.
Work cross functionally and collaboratively in BeOne with e.g. Manufacturing, Supply Chain, Regulatory CMC and other Quality teams like QPs in EU.
Ensure quality support on product commercial supply e.g. timely batch release.
Support product recalls from commercial supply chain when needed.
Perform other tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines.
Work with cross functional partners to establish Process Performance Qualification for Small Molecule products.
Author Standard Operating Procedures related to function and department.