Audit 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 ISOCFR Part 210/211 ICH FDA and EU regulatory standards and guidelines as well as management and data integrity requirements.

• Bachelors 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 drivers 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 technicalexpertiserelated to the manufacturing processes of cGMP biopharmaceuticals.

IDT a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range for this role is $83000-$105000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay (10% ICP).

We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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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.

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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .