INCOG Biopharma Services are looking for a Manager of Audits and play a pivotal role in maintaining their 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.

INCOG is offering the opportunity to contribute towards a better path to market for life-saving drugs. Having recently been voted as one of the Best Places To Work in Indiana for the fourth year in a row, INCOG is the perfect place to continue building your career!

Roles and Responsibilities:

• Lead Comprehensive Audit Program - Manage internal audits, client audits, audit responses and reports, 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

• 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

Experience and Education Requirements:

The ideal candidate will have a Bachelor’s degree in Engineering / Life Sciences / related field, as well as:

• 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

• Advanced degree (MS, PhD) in relevant scientific discipline with professional certifications such as Certified Quality Auditor (CQA)

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.