Associate Director of Audits and Supplier Quality
WHO?
Are you an experienced Quality professional with expertise in audits and supplier quality management looking for an exciting leadership opportunity with an organization where you can have an impact on global health and wellness?
We are looking for an Associate Director, Audits and Supplier Quality who will lead our comprehensive audit program and world-class supplier quality operations while building and developing high-performing quality teams. Do you naturally create new ways to deliver exceptional results and love mentoring professionals to reach their full potential? We want to meet you!
WHAT?
This position reports to the Director of Quality Systems and is responsible for leading all audit activities and supplier quality operations across INCOG’s sterile injectable manufacturing operations. The Associate Director will oversee internal audit programs, coordinate external regulatory inspections, manage client audits, lead supplier qualification and management programs, and ensure robust audit response and CAPA implementation. This role requires exceptional leadership skills to build, grow, and mentor quality teams while maintaining the highest standards of GMP compliance and regulatory readiness in our fast-paced CDMO environment.
The role responsibilities are, but are not limited to:
Leadership and Team Development
- Build and Lead Quality Teams - Recruit, develop, and mentor teams of audit and supplier quality professionals, establishing clear performance objectives, providing ongoing coaching and career development, and fostering a culture of continuous improvement, regulatory compliance, and operational excellence
- Strategic Team Planning - Assess team capabilities and resource needs, develop succession plans, and ensure adequate staffing and technical competency to support organizational growth and regulatory readiness
- Training and Knowledge Management – Develop and maintain the team’s subject matter expertise in the technical and quality aspects of sterile manufacturing and medical device assembly.
Audit Program Management
- Lead Comprehensive Audit Program - Manage internal audits, client audits, and regulatory body audits covering all GMP operations, ensuring compliance with FDA, EMA, ICH, and client requirements
- Manage External Regulatory Interactions - Serve as primary point of contact for FDA, EMA, and other health authority inspections, coordinating pre-inspection preparation, leading audit response activities, and managing post-inspection CAPA implementation and regulatory communications
- Client Audit Management - Lead client audits of INCOG, including coordinating responses, working with internal teams and client QA to resolve observations, and implementing corrective actions
- Continuous Improvement - Implement improvements to audit systems to enhance compliance and operational efficiency
Supplier Quality Management
- Supplier Qualification and Oversight - Develop and execute comprehensive supplier qualification programs, including risk assessments, audits, and ongoing performance monitoring for raw materials, components, and contract services
- Supplier Auditing - Plan and conduct comprehensive supplier audits, including pre-qualification, routine surveillance, and for-cause audits, ensuring thorough documentation and effective CAPA follow-up
- Risk Management - Conduct supplier risk assessments, develop mitigation strategies, and manage supply chain disruptions to minimize impact on manufacturing operations
- Change Control - Manage supplier changes, ensuring appropriate risk assessment, validation activities, and regulatory notifications as required
YOU!
Ideally, candidates will have a Bachelor’s degree in a scientific discipline, along with 8-10 years minimum of Pharmaceutical GMP experience with a focus on quality assurance, auditing and supplier quality management. Of that experience, a minimum of 5 years should encompass progressive leadership of quality professionals.
Additional Preferences:
- Advanced degree (MS, PhD) in relevant scientific discipline with professional certifications such as Certified Quality Auditor (CQA)
- Lean Six Sigma certification or similar process improvement training with experience in validation principles and pharmaceutical manufacturing processes
- Experience in aseptic filling operations, sterile manufacturing, or parenteral drug products
- CDMO or contract manufacturing experience
- Experience with validation principles and pharmaceutical manufacturing processes
Why INCOG?
- Paid time off, based on tenure
- 11 paid holidays
- 401(k) plan with company match up, vested immediately
- Choice of health & wellness plans
- FSA and HSA options
- Onsite wellness facility
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
Curious? Send us your resume at apply@leadcandidate.com or you can find more information on our website.
Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…
Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.
