INCOG BioPharma Services
Overview
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 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 will be at the forefront of ensuring compliance excellence while contributing to patient safety and product quality within a collaborative culture that values lean thinking and teamwork. This role resides in the Quality Systems organization and reports to the Director of Quality Systems. Responsibilities
Lead the Comprehensive Audit Program by managing internal audits, client audits, and regulatory body audits for all GMP operations, ensuring compliance with FDA, EMA, ICH, and client requirements. Lead client audits of INCOG, coordinating responses with internal teams and client QA to resolve observations and implement corrective actions and records. Manage External Regulatory Interactions as the primary point of contact for FDA, EMA, and other health authorities; oversee pre-inspection preparation, audit responses, CAPA implementation, and regulatory communications. Manage internal inspection program, including conducting audits, generating audit reports, and overseeing responses. Implement improvements to the audit system to enhance compliance and efficiency of the audit team. Direct Team Operations and Development by mentoring 2–3 audit professionals, providing training, performance management, and career development while ensuring adequate resource allocation. Ensure Documentation and Reporting Excellence through 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. Qualifications
Bachelor's degree in Life Sciences, Engineering, or a related field with thorough knowledge of FDA, EMA, ICH regulations and GMP principles for sterile manufacturing operations. Minimum 7–10 years of pharmaceutical/biotechnology industry experience with focus on quality assurance and auditing, including 3–5 years of 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 a pharmaceutical manufacturing environment. Strong leadership and communication skills with the ability to interact professionally with regulatory authorities, clients, and internal stakeholders while managing multiple priorities under pressure. Additional Preferences
Advanced degree (MS, PhD) in a 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. About INCOG BioPharma Services
INCOG BioPharma is a world-class CDMO for parenteral injectable drugs. Our culture emphasizes building long-term value for customers, service-mindedness, technical excellence, and a collaborative, team-centered approach to doing business. Location and Notice
Unless otherwise specified, all positions are based out of our Fishers, IN offices. We are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Employment decisions are based on business needs, job requirements, and individual qualifications without regard to race, color, religion or belief, sex, age, disability, or any other status protected by law.
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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 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 will be at the forefront of ensuring compliance excellence while contributing to patient safety and product quality within a collaborative culture that values lean thinking and teamwork. This role resides in the Quality Systems organization and reports to the Director of Quality Systems. Responsibilities
Lead the Comprehensive Audit Program by managing internal audits, client audits, and regulatory body audits for all GMP operations, ensuring compliance with FDA, EMA, ICH, and client requirements. Lead client audits of INCOG, coordinating responses with internal teams and client QA to resolve observations and implement corrective actions and records. Manage External Regulatory Interactions as the primary point of contact for FDA, EMA, and other health authorities; oversee pre-inspection preparation, audit responses, CAPA implementation, and regulatory communications. Manage internal inspection program, including conducting audits, generating audit reports, and overseeing responses. Implement improvements to the audit system to enhance compliance and efficiency of the audit team. Direct Team Operations and Development by mentoring 2–3 audit professionals, providing training, performance management, and career development while ensuring adequate resource allocation. Ensure Documentation and Reporting Excellence through 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. Qualifications
Bachelor's degree in Life Sciences, Engineering, or a related field with thorough knowledge of FDA, EMA, ICH regulations and GMP principles for sterile manufacturing operations. Minimum 7–10 years of pharmaceutical/biotechnology industry experience with focus on quality assurance and auditing, including 3–5 years of 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 a pharmaceutical manufacturing environment. Strong leadership and communication skills with the ability to interact professionally with regulatory authorities, clients, and internal stakeholders while managing multiple priorities under pressure. Additional Preferences
Advanced degree (MS, PhD) in a 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. About INCOG BioPharma Services
INCOG BioPharma is a world-class CDMO for parenteral injectable drugs. Our culture emphasizes building long-term value for customers, service-mindedness, technical excellence, and a collaborative, team-centered approach to doing business. Location and Notice
Unless otherwise specified, all positions are based out of our Fishers, IN offices. We are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Employment decisions are based on business needs, job requirements, and individual qualifications without regard to race, color, religion or belief, sex, age, disability, or any other status protected by law.
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