Associate Director, BioPharma Partner Audit Excellence

Danaher•Boston, MA

4d•Remote

About The Position

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). This position may be based out of a primary Danaher corporate or Operating Company hub (preferably Boston, MA, Washington, DC, or Chicago, IL). We may consider remote opportunities for the right candidate. 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. The role does not replace operating-company Quality authority or site accountability. It provides the enterprise orchestration, standard work, and single point of coordination required to make Danaher easier to audit and faster to contract with. This is not a site-auditor or administrative coordination role. The expectation is to lead partner-facing diligence as a strategic commercial enabler while preserving the integrity, independence, and decision rights of Danaher Quality and Legal teams.

Requirements

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.

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.