Director of Quality - Dietary Supplement Manufacturing

Company Overview:

Our client is a well-established and rapidly expanding contract manufacturing organization supporting some of the most recognized brands in the dietary supplement and health & wellness industries. The company combines advanced R&D, vertically integrated manufacturing, premium packaging, and regulatory expertise to deliver innovative products from concept through commercialization. Backed by significant manufacturing capacity and strong reputation for quality, the organization provides an outstanding environment for professionals looking to make a meaningful impact within a high-growth business.

Position Overview:

The Director of Quality is responsible for providing strategic leadership and oversight of all Quality Assurance, Quality Control, Regulatory Compliance, and Quality Management Systems (QMS) functions. This individual will ensure the organization consistently meets FDA regulations, cGMP requirements, customer specifications, and industry certifications while fostering a culture of quality, continuous improvement, and operational excellence.

The Director of Quality will serve as key member of the leadership team, partnering closely with Operations, Manufacturing, R&D Supply Chain, Regulatory Affairs, and executive leadership to support business growth while maintaining the highest standards of product quality and compliance.   

Key Responsibilities

Leadership & Strategy:

·       Provide strategic leadership for all Quality Assurance and Quality Control functions.

·       Develop and execute the organization’s quality strategy and alignment with business objectives.

·       Build, mentor, and develop a high-performing quality organization.

·       Foster a culture of quality, accountability, regulatory compliance, and continuous improvement.

·       Establish quality KPIs and communicate performance metrics to executive leadership.

·       Serve as the primary quality advisor to the executive leadership and strategic customers.

Quality Management System (QMS)

·       Oversee and develop, implementation, maintenance, and continuous improvement of the Quality Management System (QMS).

·       Ensure compliance with FDA 21 CFR Parts 111 and 117

·       Oversee and continuously improve:

o   SOPs

o   Document Control

o   Change Control

o   Deviation Management

o   CAPS Program

o   Supplier Quality Management

o   Complaint Investigations

o   Internal Audits Program

o   Risk Assessments Program

·       Monitor quality metrics and KPIs to drive operational excellence.

Regulatory Compliance & Audits:

·       Ensure ongoing compliance with FDA 21 CFR Part 111, cGMP, NSF, USP, HACCP, FSMA, customer-specific quality requirements.

·       Direct all FDA, state, customer, NSF, NASC, and third-party inspections and cGMP audits involving manufacturing, packaging, warehousing, and distribution.

·       Maintain continuous inspection readiness across all operations.

·       Oversee investigations responses to audit findings, regulatory observations, CAPAs, and compliance initiatives.

·       Partner with Regulator Affairs to support new product commercialization and regulatory compliance.

Product Quality & Investigations:

·       Lead investigations involving Serious Adverse Events (SAEs), Adverse Events (AEs) Product Quality Events (PQEs), Technical inquiries (Tis), customer complaints, and internal quality investigations.

·       Conduct trend analysis on quality events to support pharmacovigilance, post-market surveillance, and continuous improvement initiatives.

·       Drive effective root cause analysis and corrective/preventive actions to minimize recurring quality issues.

Laboratory Operations:

Oversee all Quality Control laboratory operations, including:

·       Incoming raw material testing

·       In-process testing

·       Finished product testing

·       Stability studies

·       Environmental monitoring

·       Laboratory compliance with applicable regulatory and industry standards.

Supplier Quality:

·       Lead supplier qualification, approval, auditing, and ongoing performance monitoring programs

·       Partner with Procurement and R&D to ensure supplier quality and material compliance.

·       Implement corrective actions and continuous improvement initiatives with support when necessary.

Operational Excellence:

·       Identify and implement opportunities to improve:

o   Manufacturing quality

o   Process capability

o   Product consistency

o   Inspection efficiency

o   Cost of Quality

Required Qualifications:

·       Bachelor’s degree in food science, Biology, Microbiology, Chemistry, Nutrition, Exercise Science, or an applicable scientific discipline.

·       10 years of progressive quality experience or more with nutritional supplements, dietary ingredients, food, or contract manufacturing industry with experience as it pertains to this role.

·       Proven effective leadership skills working to facilitate highly functioning teams in a growth-oriented and continuous improvement company.

·       Extensive experience working with: FDA 21 CFR Part 111, cGMP regulations, CAPA systems, and Root Cause Analysis methodologies.

·       Experience leading FDA, NSF, NASC, customer, and third-party audits.

·       Ability to handle multiple priorities simultaneously in a fast-paced dynamic environment.

·       Proven communication (verbal and written), interpersonal, and administrative skills.

Additional Details & Benefits:

·       Full-time with competitive compensation

·       Health Benefits package

·       PTO

·       This is an onsite position located in Tampa, Florida