Director of Quality

Summary:

The Director of Quality leads and manages all quality assurance and quality control functions within Herbs, Etc. The Director will plan, direct, or coordinate quality assurance programs, and formulate quality control policies and control quality of laboratory and production efforts. The Director will have knowledge of dietary supplements with a deep understanding of Good Manufacturing Practices (GMPs), including current good manufacturing practice in manufacturing, packaging, labeling, for dietary supplements. This role ensures the safety, efficacy, and compliance of all our products from raw material sourcing through finished product release.

Essential Job Duties:

• Establish, own, and strategically evolve the comprehensive Quality Management System (QMS), ensuring state-of-the-art compliance with FDA (e.g., cGMP, 21 CFR 111) and internal policies.
• Provide executive oversight and leadership for all Quality functions (Quality Assurance, Quality Control testing, Compliance, and Validation), ensuring seamless, integrated, and compliant operations.
• Guarantee and certify that all manufacturing, laboratory, and distribution activities strictly adhere to current Good Manufacturing Practices (cGMP).
• Act as the most senior Company Representative and primary point of contact for all regulatory inspections (e.g., FDA, State agencies) and third-party quality audits, ensuring successful and comprehensive outcomes.
• Own and direct the internal audit program and the supplier qualification process, driving timely and effective closure of all identified compliance gaps.
• Direct and manage the Quality Control (QC) laboratory operations, including budget, instrument calibration/maintenance, method development, and validation activities.
• Ensure all quality control activities, including testing of raw materials, in-process materials, and finished products, strictly meets specifications and regulatory requirements.
• Oversee all Quality Assurance processes, including batch record review, deviations, risk assessments, Corrective and Preventive Actions (CAPA), Change Control, MRB, HACCP / Food Safety Plan and Out-of-Specification (OOS) investigations.
• Establish and maintain a robust Document Control System for all quality-related records (SOPs, specifications, Master Batch Records, Certificates of Analysis), ensuring data integrity and accessibility.
• Develop, implement, and maintain comprehensive, role-specific cGMP and QMS training programs, ensuring all personnel are qualified and current on required procedures.
• Lead, mentor, and manage the QA and QC staff, fostering a strong, data-driven culture of quality and continuous improvement.
• Manage the department budget, resources, and key performance indicators (KPIs) to optimize operational efficiency and compliance spend.

Competencies:

• Strategic Mindset - Anticipates future trends and implications accurately; Readily poses future scenarios; Articulates credible pictures and visions of possibilities that will create sustainable value; Creates competitive and breakthrough strategies that show a clear connection between vision and action
• Manages Complexity - Asks the right questions to accurately analyze situations; Acquires data from multiple and diverse sources when solving problems; Uncovers root causes to difficult problems; Evaluates pros and cons, risks and benefits of different solution options
• Builds Effective Teams - Forms teams with appropriate and diverse mix of styles, perspectives, and experience; Establishes common objectives and a shared mindset; Creates a feeling of belonging and strong team morale; Shares wins and rewards team efforts; Fosters open dialogue and collaboration among the team
• Manages Conflict - Steps up to conflicts, seeing them as opportunities; Works out tough agreements and settles disputes equitably; Facilitates breakthroughs by integrating diverse views and finding common ground or acceptable alternatives; Settles differences in productive ways with minimum noise
• Drives Engagement - Structures the work so it aligns with people’s goals; Empowers others; Makes each person feel his/her contributions are important; Invites input and shares ownership and visibility; Shows a clear connection between people’s motivators and the organizational goals
• Can do the job - Competence: The worker knows how to perform the duties effectively and efficiently. Experience: The worker has done similar work before or has relevant training. Capability: The worker is physically, mentally, or technically able to meet the demands of the job. Reliability: The worker can be trusted to complete the work correctly and on time.

Work Environment:

• Ability to work independently and without administrative support. Be able to work from any location, home, airport, customer location.

Qualifications:

• Education: Bachelor's degree in a relevant scientific field (e.g., Chemistry, Biology, Pharmacy, Food Science). A Masters degree is a plus.
• Experience:
• Minimum of 8-10 years of progressive experience in Quality Management within the dietary supplement, natural product, food, or pharmaceutical industry.
• Desire 5 years of experience in a leadership/management role directing quality functions.
• Proven expertise and direct experience with cGMP is mandatory.

Skills:

• Excellent knowledge of analytical testing, laboratory safety, and instrument operation.
• Strong leadership, communication, and problem-solving skills.
• Demonstrated ability to manage regulatory inspections and significant quality events.
• Certification (e.g., ASQ Certified Manager of Quality/Organizational Excellence) is desirable.