Director of Quality

Millipore Corporation; Peterborough (NH); Vor Ort; USD 155.000 - 290.000; Vollzeit

Zusammenfassung

MilliporeSigma is seeking a Head of Site Quality to lead a ~200-person quality organization at a high-complexity Life Science manufacturing site. You will set the quality vision and oversee QA, QC, systems, compliance, supplier quality, audits, CAPA, release and disposition, and data integrity.

You will report to site leadership, drive strategic direction and day-to-day execution, manage the quality budget, and partner with production and commercial teams to embed quality at every stage of

Qualifikationen

• Bachelor's degree in Engineering, Applied Engineering, Sciences, or a related field.
• 10+ years of progressive experience in quality management within a regulated manufacturing environment.
• Demonstrated leadership of a multi-function Quality organization at meaningful scale, leading through managers.
• Proven experience leading regulatory inspections (FDA, EMA) with risk-based decisions under pressure.

Aufgaben

• Lead a ~200-person site Quality organization across QA, QC, Quality Systems, Compliance, Supplier Quality, Audits, CAPA, release and disposition, and customer complaint resolution.
• Drive strategic direction and day-to-day execution; manage talent, budgets, and KPIs with a focus on data integrity and compliance.
• Lead regulatory inspections and remediation efforts, ensuring quality systems support continuous improvement.
• Collaborate with production, technical services, and commercial functions to embed quality in all stages of operations.

Kenntnisse

Leadership

Regulatory inspections

Risk management

Ausbildung

Bachelor's degree in Engineering, Applied Engineering, Sciences, or a related field

Tools

ERP platforms

Audit management tools

eQMS

Jobbeschreibung

Work Your Magic with us! Start your next chapter and join MilliporeSigma.Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your RoleQuality is not a checkpoint - it is the foundation on which scientific progress is built.

As Head of Site Quality, you will own and lead an approximately 200-person, multi-function Quality organization for a high-complexity Life Science manufacturing site. This is a senior site leadership role: you will sit on the site leadership team, set the quality vision, and drive both strategic direction and day-to-day execution across Quality Assurance, Quality Control laboratories, Quality Systems, Compliance, Supplier Quality, Audits, CAPA, product release and disposition, customer complaint resolution, and data integrity. You will lead through a team of managers, holding full accountability for talent development, organizational design, and succession planning across the Quality function. You will own the quality budget, make business and resourcing trade-offs, and govern site-level quality KPIs that are visible to site and regional leadership. You will be expected to make sound, risk-based decisions under pressure - including during regulatory inspections, remediation programs, and complex deviation or CAPA investigations - and to demonstrate a track record of driving measurable Quality and organizational transformation. You will champion digital quality initiatives that strengthen data integrity and operational efficiency, and partner closely with production, technical services, and commercial functions to ensure quality is integrated at every stage of operations - from supplier qualification and environmental monitoring through to product release and customer complaint resolution. Your leadership will directly shape audit readiness, inspection outcomes, and the continuous improvement agenda, making a measurable and lasting impact on compliance performance and customer satisfaction.

Who You Are

Minimum Qualifications

• Bachelor's degree in Engineering, Applied Engineering, Sciences, or a related field
• 10 or more years of progressive experience in quality management within a regulated manufacturing environment
• Demonstrated leadership of a multi-function Quality organization at meaningful scale, leading through managers rather than solely as an individual technical contributor
• Proven experience leading regulatory inspections (such as FDA or EMA), including leading remediation efforts and making difficult, risk-based decisions under pressure

Preferred Qualifications

• Advanced degree in a relevant scientific or engineering discipline
• Experience owning full Quality scope, including Quality Assurance, Quality Control, Quality Systems, Compliance, Supplier Quality, Audits, CAPA, product release and disposition, and data integrity
• Experience managing a quality budget and governing site-level quality performance metrics
• Demonstrated leadership of measurable Quality or organizational transformation, with evidence of sustained improvement in compliance outcomes
• Professional certifications in quality or regulatory frameworks such as Six Sigma Black Belt, ASQ, GMP, GLP, or GxP
• Experience with quality management systems including ISO 9001, ICH Q9, and GMP in a Life Science manufacturing environment
• Expertise in risk management, deviation handling, CAPA processes, and continuous improvement methodologies
• Experience with digital quality platforms, electronic quality management systems, ERP platforms, and audit management tools
• Familiarity with material analysis tools such as FTIR, DSC, microscopy, particle counters, and integrity testing
• Understanding of validation and qualification processes, FMEA, SPC, sampling plans, and change control in regulated environments

Base Pay Range for this position

$154,700 - $290,300

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!