Director of Quality jobs in United States
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Kelly · 1 day ago

Director of Quality

Kelly Science & Clinical is seeking a Director of Quality for a direct hire opportunity with a leading global ingredient manufacturer. This role oversees all aspects of global quality and compliance, providing vision and direction for regulatory affairs and quality management systems.

OutsourcingProfessional Services
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H1B Sponsor Likelynote
Hiring Manager
Alexandre Neves, Ph.D.
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Responsibilities

Lead the implementation, ongoing maintenance, and continuous improvement of the Quality Management System (QMS), ensuring full compliance with applicable regulations for the manufacture, packaging, storage, and distribution of all products
Maintain up-to-date product, component, and packaging specifications to support purchasing and manufacturing requirements
Oversee document control policies and practices to support GMP compliance
Direct the quality department’s continuous improvement initiatives to enhance quality programs in alignment with both existing and emerging global regulations
Manage daily quality operations and build strategic infrastructure for long-term quality goals, optimizing release velocity, batch record efficiency, and testing processes to eliminate production delays and strengthen regulatory positioning
Sustain regulatory compliance across all processing and storage facilities, meeting GMP standards and all relevant licensure requirements at local, state, and federal levels
In coordination with external regulatory and legal advisors, lead the development and ongoing management of global quality and compliance strategies addressing diverse regional requirements for product distribution
Direct quality and regulatory strategies for Novel Foods (UK/EU), FDA (US), PMDA (Japan), TGA (Australia/New Zealand), and emerging international markets
Position the organization as a regulatory intelligence leader in both domestic and international cannabinoid markets
Maintain and expand key certifications (GMP, NSF, Kosher, etc.), ensuring readiness for new market opportunities
Lead customer audits and compliance reviews that reinforce our competitive advantage
Oversee internal and external audits, vendor compliance, and laboratory testing partnerships to guarantee analytical accuracy, swift turnaround, and cost efficiency
Optimize quality systems across production and supply chain functions for greater efficiency, scalability, and full regulatory compliance
Ensure comprehensive training and proficiency for all personnel in relevant policies, SOPs, and protocols to support GMP requirements and consistent manufacturing practices
Lead root cause investigations and leverage continuous improvement tools (CAPA, SPC, DMAIC) to drive systemic enhancements from quality incidents
Collaborate with R&D and executive teams to identify and advance scientific and regulatory strategies that align with organizational goals

Qualification

Quality Management SystemsRegulatory ComplianceGMP Standards21 CFR Part 111Quality Team ManagementContinuous ImprovementBachelor’s DegreeSQF CertificationInternational Regulatory ComplianceHemp Production Experience

Required

Bachelor's degree in Science, Engineering, or a related technical discipline required; advanced degree preferred
Minimum 10 years' experience leading quality in an FDA-regulated manufacturing environment (pharmaceuticals, dietary supplements, medical devices)
At least 5 years managing quality teams, including talent selection, development, and performance management
Deep expertise in 21 CFR Part 111 (dietary supplements), pharmaceutical GMPs, or equivalent standards
Demonstrated experience with regulatory agencies and third-party certification processes
Proven track record building and scaling quality systems during periods of significant growth

Preferred

SQF certification expertise
International regulatory compliance (Novel Foods, TGA, ANVISA, etc.)
Prior experience in hemp or cannabinoid production

Benefits

Comprehensive Benefits Package: Medical, Dental, Vision, FSA, 401K, Paid Time Off
Inclusive work culture with ongoing industry training, professional development, and opportunities for growth in the cannabinoid sector.

Company

We’ve been helping organizations find the people they need longer than any other company in the world.

H1B Sponsorship

Kelly has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (85)
2024 (76)
2023 (59)
2022 (74)
2021 (81)
2020 (65)

Funding

Current Stage
Public Company
Total Funding
unknown
1978-01-13IPO

Leadership Team

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Chris Layden
Chief Executive Officer
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N
Nicholas Zuhlke
Vice President, Controller, and Chief Accounting Officer
Company data provided by crunchbase