Director of Quality

Director of Quality Assurance - On Site Only Lead Quality Excellence at a Premier Dietary Supplement Manufacturer

Capstone Nutrition, a flagship manufacturing site within INW (Innovations in Nutrition & Wellness), is seeking a Director of Quality Assurance to lead quality operations for one of North America's premier dietary supplement manufacturing facilities.

Capstone manufactures powders, capsules, tablets, and liquid capsule products for many of the industry's most recognized brands. This is a high-impact leadership opportunity for a quality professional who thrives in a fast-paced manufacturing environment and is passionate about building strong teams, developing quality culture, and serving as a trusted partner to customers and regulators.

We are seeking a collaborative but decisive leader who can balance technical expertise, operational partnership, and customer engagement while maintaining the independence and integrity of the Quality function.

The Director of Quality Assurance is responsible for leading all Quality Assurance activities across manufacturing, packaging, warehouse, and quality systems functions. This role provides strategic leadership for compliance, quality culture, customer engagement, batch disposition, and continuous improvement initiatives while ensuring compliance with 21 CFR Part 111 and customer requirements. The successful candidate will serve as a key member of the site leadership team and a visible quality leader both internally and externally.

• Lead site QA programs supporting powder blending, encapsulation, tablet compression and packaging manufacturing operations.
• Process validation (IQ, OQ, PQ), analytical instrumentation, FDA regulatory requirements (GLP/cGMP/GDP), risk management/HACCP concepts, statistical process control, and statistical problem solving.
• Batch review and disposition
• Deviations and investigations
• CAPA management
• Change control
• Complaint investigations and trending
• Product holds and release decisions
• Validation Master Plan
• Ensure compliance with FDA dietary supplement cGMP requirements (21 CFR Part 111), customer standards, and internal quality systems.

• Serve as the primary contact for strategic customer relationships or provide support as needed
• Participate in customer business reviews, technical discussions, audits, and quality governance meetings.
• Communicate quality events, investigations, and risk assessments clearly and professionally to customers and senior leadership.
• Build credibility and trust through sound scientific decision-making and transparent communication.
• Support regulatory inspections and third-party certification audits.

• Drive continuous improvement in quality systems and operational performance.
• Strengthen investigation quality and root cause analysis capabilities.
• Improve CAPA effectiveness and sustainability.
• Advance inspection readiness and compliance maturity.
• Utilize data and quality metrics to identify trends and drive proactive improvements.

• Lead, coach, and develop a high-performing Quality team.
• Establish clear expectations and accountability throughout the organization.
• Build strong partnerships across Operations, Technical Services, Supply Chain, Regulatory Affairs, and Commercial teams.
• Foster a culture of quality ownership and right-first-time execution.

• Bachelor's degree in Food Science, Microbiology, Chemistry, Biology, Engineering, or related scientific discipline.
• 10+ years of progressive quality leadership experience within dietary supplements, pharmaceuticals, nutraceuticals, sports nutrition, food manufacturing, or related regulated industries.
• Strong working knowledge of:
• 21 CFR Part 111
• Process and equipment validations
• CAPA systems
• Investigations and root cause analysis tools
• Change control
• Risk management principles including Failure Modes and Effect Analysis (FMEA)
• Experience leading customer, regulatory, and third-party audits.

• Dietary supplement manufacturing experience involving powders, capsules, tablets, and probiotics.
• Experience supporting major national supplement brands.
• Experience with NSF, UL, SQF, or other third-party certification programs.
• Strong understanding of microbiological controls, allergen management, and supplier quality systems.

The ideal candidate will be:

• A strong communicator who can effectively engage with customers, regulators, executives, and frontline employees.
• Collaborative without compromising quality standards.
• Visible and engaged on the manufacturing floor.
• Comfortable making difficult decisions and defending them with scientific rationale.
• Calm under pressure and solutions-oriented.
• Passionate about developing people and building strong teams.
• Focused on creating sustainable systems rather than relying on heroic efforts.