Description

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.

Essential Job Functions:

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

Special Job 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

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

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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