Associate Director of Audits and Supplier Quality

INCOG BioPharma Services•Fishers, IN

5d•Onsite

About The Position

Join INCOG Biopharma Services as Associate Director of Audits and Supplier Quality and play a pivotal leadership role in maintaining our reputation as a trusted CDMO. As part of our Quality organization, you’ll have direct impact on patient safety and product quality while advancing your career in a growing, innovative company. This exciting leadership position offers the opportunity to shape comprehensive audit and supplier quality strategy, lead regulatory interactions with FDA and EMA, and build, mentor, and develop high-performing quality teams. You’ll be at the forefront of ensuring compliance excellence while working in a collaborative, “All in” culture that values lean thinking and team collaboration. 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.

Requirements

Minimum 8-10 years pharmaceutical/biotechnology industry experience with focus on quality assurance, auditing, and supplier quality management
Minimum 5+ years progressive leadership experience managing and developing quality professionals in a GMP environment
Bachelor’s degree in Life Sciences, Engineering, Chemistry, or related field with thorough knowledge of FDA, EMA, ICH regulations and GMP principles for sterile manufacturing operations
Direct FDA and/or EMA inspection experience and knowledge of international regulatory requirements, computerized systems validation, and data integrity standards
Demonstrated expertise with supplier qualification, auditing, vendor management, risk assessment, and quality management systems in pharmaceutical manufacturing
Proven ability to recruit, mentor, and develop high-performing teams with track record of building team capability and fostering professional growth
Strong leadership and communication skills with ability to interact professionally with regulatory authorities, suppliers, clients, and internal stakeholders while managing multiple priorities

Nice To Haves

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

Responsibilities

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.
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 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