Sr. Director, Quality Control & Analytical Development
On-siteDurham, North Carolina, United States
Job Summary
Develop and implement the strategy and roadmap for Quality Control and Analytical Development aligned with the Global Quality Strategy. Lead the QC and Analytical Development team by setting clear priorities, providing feedback, and fostering career development. Oversee all operations including In Process Testing, Bulk Release, Stability Testing, Microbiological Testing, and Environmental Monitoring while managing contracted testing labs for method transfer and compliance. Support client visits, audits, and regulatory agency inspections to ensure all areas conform to cGMP and remain audit-ready. Manage budgets, timelines, and performance requirements while collaborating with cross-functional leaders. Administer company policies and complete administrative tasks such as timecard approvals and expense reports. Coach direct reports, participate in recruitment, and address performance gaps. This role requires flexibility to support 24/7 manufacturing facility operations and adherence to strict GMP standards.
Required Qualifications
- Bachelor's Degree in Chemistry, Biochemistry, Microbiology or related field
- Master of Science (M.Sc.) in a related discipline
- Ph.D. in Science
- 15+ years of experience
- 13+ years of experience
- 11+ years of experience
- 12+ years of people management, leadership, and team management experience
- Technical and regulatory understanding and experience of biologics, gene, and/or cell therapy QC
- Experience leading client site visits, audits, and regulatory inspections
- Experience managing in a matrix organization and collaborating at a global level
- Experience working in a regulated GMP environment
- Strong orientation for quality, compliance, business ethics and customer service
- Strong leadership, collaboration, team building, program management and organizational skills
- Proven ability to develop, communicate, and execute plans and strategies with a wide range of stakeholders
- High level of integrity and a drive for continuous improvement
- Strong collaboration and team building skills
- Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution
- Excellent interpersonal, organizational, and written and oral communication skills
- Mastery knowledge of document management and lifecycle, and quality systems and their interconnections
- Mastery of GMP, regulations, and inspection/audit readiness
- Ability to coach, lead, and develop individual contributors
- Must be flexible to support 24/7 manufacturing facility
- Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
- Ability to discern audible cues
- Ability to sit for prolonged periods of time up to 60 minutes
- Ability to conduct activities using repetitive motions that include wrists, hands or fingers
- Ability to conduct work that includes moving objects up to 10 pounds
Desired Qualifications
- 12+ years of experience working in a regulated GMP environment
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.