Instil Bio is seeking a driven and experienced Sr. Manager/Associate Director, Supplier Quality. The successful candidate will be a highly motivated hands-on leader who has experience in Supplier Quality and implementation of the SQ principles, procedures, and processes including risk identification, evaluation, and management.
The candidates must be knowledgeable of vendor, supplier and material management process and systems.
In this role, the Sr. Manager/Associate Director, Supplier Quality will be expected to own and manage the Supplier Quality management program, develop and execute strategic direction and oversight pertaining to external auditing and supplier quality, and collaborate and drive cross-functionally to execute the SQM program.
This position will routinely interact with Quality, Supply Chain, Procurement, Manufacturing. This position will report to the Sr. Director, Quality.
Responsibilities (include but not limited to):
- Manage the development, deployment, and maintenance of the Supplier Quality program
- Accountable for the supplier compliance of Audits, Supplier Quality Agreements (SQA), SCARs, Supplier Questionnaires, Supplier Request for Information, and management of supplier-initiated changes, including:
- Supplier qualification and specification development processes using phased appropriate, risk-based tools for qualification, classification, and performance monitoring
- Quality Agreements to assure key quality expectations are reflected in the supplier’s operations and updates for changes are managed
- Conduct supplier audits (Develop plan, prepare reports, communicate findings, audit responses, compliance assessment outcome)
- Maintain approved supplier list
- Monitor and report on meaningful SQM performance metrics (KPI) as well as Supplier performance metrics
- Collaborate with cross-functional stakeholders on matters pertaining to supplier controls, significant concerns related to Quality system performance, risk-based audit execution, issue escalation, procurement strategy and regulatory compliance
- Participate as a representative of SQM on project teams
- Assure all SQM related quality documentation and records are completed thoroughly and timely to maintain compliance
- Support inspection readiness plans and interact with regulatory agencies during inspections on SQM-related matters, as needed
- Hire, manage, develop, coach, and mentor staff
- Implement continuous improvement projects
- Manage department budget
- Complete other responsibilities, as assigned
Requirements and Recommendations:
- Bachelor’s degree in a scientific discipline
- 8-10 years Quality/Supplier Quality experience in a GMP environment (biotechnology, pharmaceutical, and/or cell therapy operations)
- Travel may be required, up to 20 % (domestic and international)
- It is critical that you have:
- Experience across multiple Quality areas (QA, QC, Systems and Compliance
- In-depth knowledge of and ability to apply GMP in conformance to the US and EU
- Experience working and direct interface with regulatory agencies
- Experience writing, evaluating, and closing investigations, CAPAs and change control records
- In-depth understanding with vendor, supplier and material management process and systems
- Experience with Quality Risk Management principles
- Good technical report writing skills
- It is strongly encouraged that this role have:
- ASQ’s Certified Supplier Quality Professional (CSQP)
- PMP certification
- Understanding and experience of cell therapy processes
- Facility start-up or quality systems/SQM implementation experience
- Personal Skills:
- Excellent critical thinking, analytical, and problem-solving skills
- Excellent interpersonal, influencing, verbal, and written communication skills
- Strong courage of conviction and conflict resolution skills
- Ability to work effectively in a dynamic, complex, and fast paced team environment
- Demonstrated ability to multi-task effectively and adjust workload based on changing priorities
- Strong demonstrated strategic thinking capability