Lead Candidate · 4 weeks ago
QA Audit Manager
Fishers, IN
Full-time
Onsite
Senior Level
7+ years expINCOG Biopharma Services is looking for a Manager of Audits to maintain their reputation as a trusted GMP-certified CDMO. This leadership role involves shaping audit strategy, leading regulatory interactions with FDA and EMA, and mentoring a dedicated team of audit professionals.
EmploymentHuman ResourcesRecruitingStaffing Agency
Hiring Manager
Megan Peacock
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
Qualification
Required
Bachelor's degree in Engineering / Life Sciences / related field
7-10 years pharmaceutical/biotechnology industry experience with focus on quality assurance and auditing
Minimum 3-5 years supervisory or management experience
Direct FDA and/or EMA inspection experience
Knowledge of international regulatory requirements
Computerized systems validation knowledge
Data integrity standards knowledge
Preferred
Advanced degree (MS, PhD) in relevant scientific discipline
Professional certifications such as Certified Quality Auditor (CQA)
Company
Lead Candidate
Lead Candidate is a recruiting company that provides staffing, talent management, and HR solutions for the pharma sector.
Founded in 2021Newcastle Upon Tyne, Newcastle upon Tyne, GBR
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase