Director of Quality

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role
Quality 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. For more information click here.