Associate Director, BioPharma Partner Audit Excellence
Danaher Corporation
Summary
The Associate Director, BioPharma Partner Audit Excellence serves as the enterprise BioPharma point person for facilitating partner audits across Danaher Diagnostics operating companies. The role creates a seamless, credible, and standardized audit experience for prospective and existing biopharma partners, helping remove diligence barriers and accelerate progression toward master collaboration agreements and master service agreements. This position reports to the Vice President, BioPharma Marketing & COE Operations, and is part of the Biopharma Center of Excellence (COE).
Job description
This leader coordinates the end-to-end audit lifecycle across the BioPharma Center of Excellence, operating-company Quality and functional teams, and the partner. The role establishes common readiness standards, orchestrates cross-company responses, maintains a controlled body of reusable evidence, drives timely closure of findings, and provides clear visibility to commercial and executive stakeholders. The successful candidate will combine quality and compliance fluency, program leadership, customer orientation, and strong matrix influence.
Key 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.
The Essential Requirements of the Job Include
- Bachelor's degree in life sciences, quality, engineering, pharmacy, regulatory affairs, or a related field required; advanced degree or relevant quality certification preferred.
- 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 Requirements: ability to travel 25%
Requirements
- Bachelor's degree in life sciences, quality, engineering, pharmacy, regulatory affairs, or a related field required
- Advanced degree or relevant quality certification preferred
- 8+ years of progressive experience in quality, supplier or customer audits, quality systems, compliance, clinical or laboratory operations, regulatory affairs, due diligence, or cross-functional program leadership
- Experience within diagnostics, medical devices, biopharma, biotechnology, CROs, or a related regulated industry
- 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
- Ability to travel 25%
Benefits
- Paid time off
- Medical, Dental & Vision
- 401(k)
- Bonus/incentive pay
- Remote work arrangement
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.