INCOG BioPharma Services Careers

Description

Join INCOG Biopharma Services as a Manager of Audits and play a pivotal role in maintaining our reputation as a trusted GMP-certified CDMO. This exciting leadership position offers the opportunity to shape audit strategy, lead regulatory interactions with FDA and EMA, and mentor a dedicated team of audit professionals. 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. As part of our Quality Systems organization, you'll have direct impact on patient safety and product quality while advancing your career in a growing, innovative company that puts operational excellence at the center of everything we do.

This position reports to the Director of Quality Systems and is responsible for leading all audit activities across INCOG's sterile injectable manufacturing operations. The Manager of Audits will oversee internal audit programs, coordinate external regulatory inspections, manage client and supplier audits, and ensure robust audit response and CAPA implementation. This role requires strong leadership skills to manage a small team while maintaining the highest standards of GMP compliance and regulatory readiness in our fast-paced CDMO environment.

Essential Job Functions:

• 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

• Lead client audits of INCOG, including coordinating the responses to the client, working with internal teams as well as internal and client QA teams to resolve observations and implement actions and records in response

• 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

• Manage internal inspection program, including executing audits, audit reports, and overseeing responses

• Implement improvements to the system to improve compliance and efficiency of the audit team’s operations

• Direct Team Operations and Development - Manage and mentor 2-3 audit professionals, providing training, performance management, and career development while ensuring adequate resource allocation and team readiness for all audit activities

• Ensure Documentation and Reporting Excellence - Prepare comprehensive audit reports with risk assessments and corrective action recommendations, maintain GMP-compliant audit documentation, and provide regular management reporting on audit program metrics and compliance status

Special Job Requirements:

• Bachelor's degree in Life Sciences, Engineering, or related field with thorough knowledge of FDA, EMA, ICH regulations and GMP principles for sterile manufacturing operations

• Minimum 7-10 years pharmaceutical/biotechnology industry experience with focus on quality assurance and auditing, including minimum 3-5 years supervisory or management experience

• Direct FDA and/or EMA inspection experience and knowledge of international regulatory requirements, computerized systems validation, and data integrity standards

• Demonstrated experience with regulatory inspections, audit methodologies, risk assessment, CAPA systems, and quality management systems in pharmaceutical manufacturing environment

• Strong leadership and communication skills with ability to interact professionally with regulatory authorities, clients, and internal stakeholders while managing multiple priorities under pressure

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

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.

By submitting your resume and details, you are declaring that the information is correct and accurate.