Associate Director, Supplier Quality Management - United States
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- Our company is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
- The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
- We are seeking a highly motivated individual to join us as an Associate Director, Supplier Quality Management (SQM).
- You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.
- This individual will work cross functionally to execute and improve the SQM program for contract test labs (CTL) and testing material specifications (TMS).
- Accountable for the GMP compliance of: audits, QTAs, SCARs, management of supplier initiated changes.
- Manage cross-functionally within the company and externally to assure compliance and strong relationships with the labs and suppliers.
- Collaborate within SQM team to improve:
- supplier qualification and specification development processes that will use risk-based tools for qualification, classification and monitoring.
- supplier QTA process and assure a process to assure key quality expectations are reflected in supplier’s operations and updates for changes are managed.
- Supplier initiated change notifications
- phase-appropriate material and supplier requirements to meet Phase 2 and PPQ timelines
- Assure audit schedule and approved supplier list (Oracle Agile and EBS) are maintained.
- Monitor and report on meaningful performance metrics
- Provide leadership and direction for lab-related and TMS issues - SCARs, CAPAs, OOS.
- Lead, develop and manage staff.
- Support inspection readiness plans and interact with regulatory agencies during inspections on SQM-related matters, as needed.
- Ability to travel up to 25%
- Perform other duties as assigned.
- Bachelor’s degree in biological sciences or related field with minimum of 10 years’ experience in a pharmaceutical or biologics supplier quality management role; biologics or vaccines experience preferred
- Previous experience managing and developing staff with a minimum of 8 years of experience.
- Experience auditing CTLs, testing materials/raw materials, sterilization facilities.
- Experience with direct FDA interaction (or other regulatory agencies) required
- ASQ Certified Quality Auditor preferred
- Experience writing, evaluating and closing investigations, CAPAs and change control records.
- In-depth knowledge of and ability to apply GMP in conformance to US, EU and ROW standards
- Willingness to think outside of the box and adapt best practices to this small, but growing environment
- Proficient in MS Word, Excel, and Power Point
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.
- Our company is an equal opportunity employer.
- We are able to offer the opportunity to be part this successful, fast growing company. A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.