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INCOG BioPharma Services · 3 months ago

QA Audit Manager

Fishers, Indiana

Full-time

Onsite

Senior Level

7+ years exp

INCOG BioPharma Services is a trusted GMP-certified CDMO seeking a Manager of Audits to lead their audit strategy and ensure compliance excellence. This leadership role involves managing internal and external audits, regulatory interactions, and mentoring a team of audit professionals to maintain high standards of GMP compliance in a collaborative environment.

BiopharmaBiotechnologyManufacturingPharmaceutical

Responsibilities

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

Qualification

GMP complianceFDA regulationsEMA regulationsQuality management systemsCAPA systemsAudit methodologiesRisk assessmentTrainingDevelopmentLean Six SigmaComputerized systems validationLeadership skillsCommunication skillsTeam management

Required

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

Preferred

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

Company

INCOG BioPharma Services

Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.

Founded in 2020

Fishers, Indiana, USA

201-500 employees