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Danaher

Makes tools for drug research and medical testing

Associate Director - BioPharma Partner Audit Excellence

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeBoston, MA, USAIn-person

About the Job

Requirements

  • A bachelor's degree in life sciences, quality, engineering, pharmacy, regulatory affairs, or a related field is required.
  • Demonstrated experience in quality, supplier or customer audits, quality systems, compliance, clinical or laboratory operations, regulatory affairs, due diligence, or cross-functional program leadership within diagnostics, medical devices, biopharma, biotechnology, CROs, or a related regulated industry, typically gained through 8+ years of progressive experience.
  • Working knowledge of regulated quality systems and audit practices relevant to diagnostic development, laboratory services, clinical research, software or data-enabled solutions, and biopharma-sponsored programs.
  • Proven ability to lead complex, multi-site or cross-business diligence activities and coordinate accurate responses across Quality, Legal, Regulatory, Privacy, Information Security, R&D, Clinical, Operations, Finance, and commercial stakeholders.
  • Ability to travel globally as required to support partner and site audits; travel requirement is 25%.

Responsibilities

  • Serve as the central coordinator for BioPharma partner audits and quality diligence activities across Danaher Diagnostics operating companies, sites, and delivery models.
  • Lead and manage the full audit lifecycle, including planning, scope definition, stakeholder alignment, audit execution, issue resolution, and closure of findings.
  • Develop and standardize audit processes, tools, and knowledge systems, including playbooks, readiness assessments, evidence repositories, communication protocols, and response templates.
  • Drive audit readiness and contracting success by partnering with cross-functional teams to proactively identify, address, and escalate diligence risks that could impact agreements or partner commitments.
  • Enhance partner experience and continuous improvement through clear governance, performance metrics, disciplined follow-through, DBS-based problem solving, and scalable audit practices across the BioPharma ecosystem.

Desired Qualifications

  • An advanced degree or relevant quality certification is preferred.

About the Company

Danaher

Makes tools for drug research and medical testing

Danaher makes instruments, tests and laboratory supplies for drug developers, researchers and clinicians, spanning the path from biological research to clinical patient diagnosis. Its businesses include Cytiva for drug manufacturing, SCIEX for chemical analysis and Beckman Coulter for laboratory testing, linking specialized tools across healthcare workflows. Customers use its equipment to study cells, produce biological medicines and analyze patient samples; the group earns money by selling instruments, reagents, software and support services through its operating companies. Danaher was established in 1984 and is headquartered in Washington, DC.

Company size
10,001+
Company stage
IPO
Headquarters
Washington, DC
Founded
1984

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