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.
IDT, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's 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 $83,000-$105,000. 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 Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
