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

Essential Functions Of The Job

• 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 CMOs.
• 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.

Education/Experience Required

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

Supervisory Responsibilities

• 4+ years management experience.
• Responsible for management, development and co-ordination of a medium sized team of direct staff who are based in the USA.
• 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.

Computer Skills

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

Other Qualifications

• 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.

Global Competencies

• Fosters Teamwork.
• Provides and Solicits Honest and Actionable Feedback.
• Self-Awareness.
• Demonstrates Initiative.
• Entrepreneurial Mindset.
• Continuous Learning.
• Communicates with Clarity.

Salary Range

$143,400.00 - $193,400.00 annually

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness