Position OverviewThe
Quality Director, North America is the senior quality leader responsible for Quality Assurance, Quality Control, Quality Systems, regulatory compliance, and continuous improvement across the company's U.S. and Canadian manufacturing facilities.
This leader will oversee compliance with
21 CFR Part 111 and 21 CFR Parts 210/211, lead regulatory inspections and customer audits, strengthen the Quality Management System, and ensure consistent quality standards across both North American sites.
The role also serves as the primary North American quality partner to the company's Global Quality organization and as a senior quality contact for customers.
Key Responsibilities- Lead Quality Assurance, Quality Control, and Quality Systems across two North American manufacturing facilities.
- Serve as head of the North American Quality Unit with independent authority over product disposition and release.
- Own and continuously improve the North American Quality Management System.
- Ensure compliance with 21 CFR Part 111, Parts 210/211, Part 11, OTC drug requirements, and applicable Canadian regulations.
- Oversee CAPA, deviations, investigations, change control, complaints, document control, validation, laboratory controls, training, and product release.
- Lead FDA, Health Canada, customer, certification-body, and third-party audits and inspections.
- Own responses to regulatory observations, including FDA Form 483s, through verified closure.
- Maintain supplier qualification and verification programs and partner with Procurement and Supply Chain on supplier quality and risk.
- Oversee food safety, facility compliance, certifications, recalls, and traceability programs.
- Serve as the senior quality contact for customers regarding audits, complaints, specifications, investigations, and quality agreements.
- Partner with Global Quality to align standards and support products manufactured across international facilities.
- Establish and monitor quality KPIs and drive measurable continuous improvement.
- Build, mentor, and retain a high-performing quality organization across multiple sites.
QualificationsRequired
- Bachelor's degree in Chemistry, Microbiology, Biology, Pharmacy, Food Science, Engineering, or related scientific discipline.
- 12+ years of progressive quality experience in FDA-regulated manufacturing, including at least 5 years in senior quality leadership.
- Hands-on experience with both 21 CFR Part 111 and 21 CFR Parts 210/211.
- Proven experience leading FDA inspections and customer audits, including preparation of responses to FDA Form 483 observations.
- Strong knowledge of CAPA, validation, investigations, data integrity, supplier qualification, and quality risk management.
- Experience leading Quality across multiple sites or complex regulatory environments.
- Strong leadership, communication, and customer-facing executive presence.
- Ability to travel domestically and internationally.
Preferred
- Experience with gummy, confectionery, or solid oral dosage manufacturing.
- Experience within a CDMO or contract manufacturing environment.
- Health Canada regulatory experience.
- Experience working within a global or matrixed Quality organization.
- PCQI, ASQ CQA, CQE, CMQ/OE, or similar professional certification.
- Advanced scientific or technical degree.
What Success Looks LikeWithin the first year, this leader will have:
- Established a clear compliance and remediation roadmap across both North American facilities.
- Strengthened inspection readiness and successfully managed regulatory and customer audits.
- Harmonized key Quality Management System processes across sites.
- Reduced overdue CAPAs, deviations, and complaint cycle times.
- Built a strong and accountable quality leadership team.
- Established an effective working relationship with the company's Global Quality organization.
