Director, Supplier Quality
GeneCoda has been engaged to identify and evaluate candidates for a Director of Supplier Quality. This is a hybrid position working remotely with periodic visits to Research Triangle Park, NC for meetings, audits, and inspections. Ideally, candidates will live within commuting distance.
About Our Client:
Our client is an innovative, commercial stage biopharmaceutical company developing medically important pharmaceutical products to treat B-cell diseases in both hematology and autoimmune therapeutic areas with unmet needs. Our client’s products span early stage development through commercial.
The Director of Supplier Quality is responsible for supplier qualification/management, audit support, and inspection readiness. The role requires a solid understanding of Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and FDA inspections and audits. The candidate should have expertise in supplier qualification, oversight and management, and a good understanding of GCP standards.
- Identify clinical risks and perform gap analyses of existing systems and processes; and propose improvements in collaboration with cross-functional development and GXP quality team.
- Provide expertise and strategy to resolve GCP/GLP issues based on knowledge of regulations, guidelines, and relevant SOPs.
- Schedule, plan, and oversee execution of internal & external GCP/GLP audits. Effectively assess and communicate audit outcomes and potential deficiency impact.
- Proactively identify quality issues/discrepancies, communicate, and effectively resolve issues in collaboration with internal and external partners.
- Lead or support preparations for internal and CRO regulatory inspections.
- Interact directly with regulatory agencies and internal auditors during audits and inspections.
- Develop and implement supplier quality programs, policies, and procedures to ensure compliance with GCP, FDA, and EU regulations.
- Evaluate suppliers for qualification and conduct audits when needed to ensure compliance with established standards, regulations, and contractual requirements.
- Collaborate with internal teams to resolve supplier-related issues and implement corrective and preventive actions.
- Monitor supplier performance and implement improvement initiatives, as necessary.
- Monitor and report global regulatory compliance trends and provide updates and analyses to senior management.
- Establish, collect, and report metrics on the status of supplier qualifications, auditing activities, and inspection readiness.
Education: Bachelor of Science degree in a scientific discipline, technology, engineering, or related field. An advanced, post-graduate degree is desirable.
Experience and Qualifications:
- 8 or more years of experience in supplier quality management, with a focus on supplier qualification and audit readiness support.
- Extensive knowledge of GCP/GLP and FDA regulations, as well as experience with audits and inspections.
- Some GvP experience for both clinical and post-marketing settings is highly desirable.
- Experience with GMP is a plus.
- Experience with quality management systems such as TrackWise, Veeva is a plus.
- Ability to influence and work effectively across the entire organization including cross-functional project teams.
- Strong collaborative skills. Team player mentality.
- Effective decision-making, analytical and problem-solving
- Ability to prioritize, organize and manage multiple projects simultaneously.
- Excellent interpersonal skills.
- Excellent verbal and written communication skills.
GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state, or local law.