Audit Manager

Quality Assurance Manager

In this role, you will have the opportunity to:

Lead all aspects of the internal and external GMP and quality audit programs, including audit planning, execution, report issuance, CAPA review, effectiveness verification, and audit closeout.

Serve as a key quality and compliance resource by maintaining current knowledge of FDA inspectional trends, cGMP requirements, global regulatory expectations, and industry best practices, and communicating relevant updates throughout the organization.

Coordinate audit logistics and readiness activities, including preparation of standard audit documentation, facility tours, audit schedules, document repositories, subject matter expert coordination, client communications, and audit tracking processes.

Partner with cross-functional teams to identify compliance risks, support problem-solving initiatives, develop effective corrective and preventive actions, and strengthen regulatory compliance, product quality, and inspection readiness across the organization.

The essential requirements of the job include:

• Experience leading or participating in internal, external, customer, supplier, or regulatory audits and inspections, including FDA, ISO, Notified Body, or equivalent regulatory organizations.
• Strong knowledge of quality systems, ICH Q10, cGMP, ISO 13485, 21 CFR Part 210/211, ICH, FDA, and EU regulatory standards and guidelines, as well as management and data integrity requirements.
• Bachelor's degree in Life Sciences, Engineering, Quality, Regulatory Affairs, or a related scientific discipline with 4+ years of experience in a quality, compliance, or auditing role within a cGMP-regulated environment.

Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role

• Ability to travel – May require overnight travel, up to 20%
• Must have a valid driver's license with an acceptable driving record

It would be a plus if you also possess previous experience in:

• Leading audit programs within pharmaceutical, biotechnology, biologics, cell and gene therapy, or other highly regulated manufacturing environments.
• Preparing for, hosting, and responding to regulatory agency inspections, including FDA, international regulatory authorities, and third-party certification audits.
• Developing audit readiness programs, inspection preparation tools, audit documentation systems, and standardized audit processes that improve organizational efficiency and regulatory compliance.
• Applying technical expertise related to the manufacturing processes of cGMP biopharmaceuticals.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.