Director of Quality

Merck•Jaffrey, NH

18d•$154,700 - $290,300

About The Position

The Head of Site Quality is a senior site leadership role responsible for leading an approximately 200-person, multi-function Quality organization at a high-complexity Life Science manufacturing site. The role sits on the site leadership team and sets the Quality vision, 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. The Director leads through a team of managers and is accountable for talent development, organizational design, and succession planning across the Quality function. The role owns the quality budget, makes business and resourcing trade-offs, and governs site-level quality KPIs visible to site and regional leadership. It requires sound, risk-based decisions under pressure, including during regulatory inspections, remediation programs, and complex deviation or CAPA investigations, along with a track record of measurable Quality and organizational transformation. The Director champions digital quality initiatives to strengthen data integrity and operational efficiency, and partners with production, technical services, and commercial functions to integrate quality throughout operations—from supplier qualification and environmental monitoring through product release and customer complaint resolution. The role shapes audit readiness, inspection outcomes, and continuous improvement to improve compliance performance and customer satisfaction.

Requirements

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 inspections, including leading remediation efforts and making difficult, risk-based decisions under pressure.

Nice To Haves

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.

Responsibilities

Lead an approximately 200-person, multi-function Quality organization at a high-complexity Life Science manufacturing site.
Set the site Quality vision and drive 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.
Lead through a team of managers and oversee talent development, organizational design, and succession planning across the Quality function.
Own the quality budget, make business and resourcing trade-offs, and govern site-level quality KPIs.
Make risk-based decisions under pressure during regulatory inspections, remediation programs, and complex deviation or CAPA investigations.
Drive measurable Quality and organizational transformation.
Champion digital quality initiatives that strengthen data integrity and operational efficiency.
Partner with production, technical services, and commercial functions to integrate quality throughout operations.
Shape audit readiness, inspection outcomes, and continuous improvement to improve compliance performance and customer satisfaction.