Associate Director, BioPharma Partner Audit Excellence

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

Within Danaher the work our diagnostic businesses do saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

Were accelerating the development of cutting-edge diagnostics to solve some of the worlds most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. Were bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together were expanding access to precision diagnostics for millions of people worldwide - and were using our unmatched global scale and proven playbook to make it happen from hospital labs to mobile clinics. By helping providers patients and families get faster more precise diagnostic results were improving treatment options and saving lives.

Learn about the Danaher Business System which makes everything possible.

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.

• 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.

• Bachelors 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%

Within Danaher Diagnostics we offer 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.

Within Danaher Diagnostics we believe in designing a better more sustainable workforce. We recognize the benefits of flexible remote working arrangements for eligible roles and are committed to providing enriching careers no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working within Danaher Diagnostics can provide.

The annual salary range for this role is $165000-$185000. 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.

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.

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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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