Director of Quality

SUMMARY The Director of Quality leads the organization's quality function across body care and OTC product lines, ensuring all manufacturing processes and finished goods consistently meet company, customer, and regulatory requirements. This role is accountable for building and sustaining a robust Quality Management System, driving a culture of quality and compliance, and partnering cross-functionally to support safe, effective, and regulatory-ready products. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

ESSENTIAL DUTIES AND RESPONSIBILITIES

(include but are not limited to the following) 1. Quality Management System (QMS): Develop, implement, and maintain an effective Quality Management System (QMS) covering body care and OTC product manufacturing. Ensure QMS processes are aligned with applicable regulatory frameworks, including 21 CFR Parts 210/211 (pharmaceutical cGMP), ISO 22716 (cosmetics GMP), and ICH quality guidelines, and that they meet all applicable regulatory requirements. Lead the review, update, and audit of quality procedures and practices to ensure compliance and continual improvement. 2.

Product Quality Control/Assurance:

Oversee the inspection and testing of raw materials, in-process goods, and finished products to ensure they meet company and regulatory quality standards. Ensure that manufacturing processes meet defined specifications and tolerances to deliver products that are safe and effective. Lead investigations into product quality issues, customer complaints, and non-conformities, and develop corrective and preventive actions. Manage lab testing, calibration, and maintenance of FTIR, HPLC, viscometer, penetrometer and other lab equipment as needed. Authority to release or reject product after testing, review, and investigation, if needed. Supervise QC laboratories, stability programs, microbiological testing, and product validation studies. 3.

Regulatory Compliance:

Ensure compliance with all applicable regulations governing both pharmaceutical manufacturing (21 CFR Parts 210/211) and body care/cosmetic products (FDA, EU Cosmetics Regulation, USDA, ISO 22716, cGMP standards). Lead efforts to maintain certifications and audit readiness across all product lines, including FDA inspections, CAPA processes, and third-party certifications such as Organic (Oregon Tilth) and Halal (IFANCA). Lead internal audits and host external regulatory inspections (e.g., FDA) and customer audits. Stay updated on industry regulations, trends, and new technologies to proactively ensure product quality and safety. Approve or reject all procedures and specifications impacting the identity, strength, quality, and purity of the drug product. 4.

Team Leadership and Development:

Manage and mentor the quality team, ensuring high performance, collaboration, and skill development. Provide leadership in building a culture of quality, safety, and continuous improvement within the manufacturing plant. Develop training programs and materials to enhance the team's understanding of quality principles and product standards. 5.

Supplier Quality Management:

Work closely with supply chain to ensure the quality and compliance of raw materials and packaging components used across body care and OTC product lines, including supplier qualification and approved vendor list management. Establish and monitor supplier quality metrics and conduct supplier audits and assessments to ensure product specifications are met. Develop and maintain strong relationships with suppliers to resolve quality issues quickly and effectively. 6.

Continuous Improvement:

Lead quality improvement projects using tools such as Six Sigma, Lean, or Kaizen to enhance manufacturing processes and reduce waste. Drive process optimization initiatives to improve product quality, consistency, and cost-effectiveness. Drive resolution of nonconformances, deviations, and product quality issues using structured problem-solving methodologies (e.g., CAPA, root cause analysis). Implement and monitor KPIs (Key Performance Indicators) to track the effectiveness of quality management efforts. 7.

Customer and Consumer Focus:

Address and resolve customer complaints related to product quality or safety, coordinating with customer service and production teams as needed. Use customer feedback to drive quality improvements and ensure customer satisfaction. Participate in the product development process, providing input on product formulation, packaging, and production to ensure quality and regulatory compliance. 8.

Reporting and Documentation:

Prepare and present reports on quality performance, trends, and improvement initiatives to senior management. Maintain accurate documentation related to quality processes, audits, investigations, and corrective actions. Ensure the proper documentation and traceability of all quality-related activities. 9.

Additional Responsibilities:

The Director of Quality shall report any product issues relating to quality and product safety to the Chief Operating Officer while handling the daily duties as they relate to staffing and testing. Display and promote company values (

ASPIRE:

Attitude, Safety, Passion, Integrity, Relationship, and Evolve). Other duties as assigned.

REQUIRED SKILLS AND ABILITIES

Strong written and verbal communication skills with prevalent professional demeanor. Ability to mentor, train, motivate, direct, and empower a team. Strong leadership skills. High ethical standards. Excellent planning and organizational skills. Ability to develop personnel and equipment structures to support present and future operations. Analytical skills to identify and resolve problems in a timely manner. Ability to work effectively across departmental teams. Maintain professional technical knowledge. Mathematical aptitude. Proficient in Microsoft Office Suite Products and ability to learn new systems quickly.

EDUCATION AND/OR EXPERIENCE

Bachelor's degree in relatable field preferred. A minimum of 5-7 years of management and/or leadership experience required. A minimum of 5+ years' experience in quality assurance or quality management within pharmaceutical, body care, or similarly regulated manufacturing is required. Experience in laboratory testing that includes the use of the following instrumentation: Brookfield, viscometer, penetrometer, FTIR, HPLC, UV/VIS preferred. Experience with a wide variety of measuring instruments and complicated product development is preferred. Experience with and knowledge of internal audits. Experience with quoting projects, product cost analysis, and ROI analysis preferred. Technical writing experience preferred. Knowledge of analytical theories required. In-depth knowledge of cGMP regulations (21 CFR Parts 210/211), ISO 22716, OSHA requirements, and pharmaceutical/cosmetic quality standards required. Knowledge of inspection and quality control methods and equipment Knowledge of material inspection methods and techniques preferred. Knowledge of metric and dashboard development preferred. Training and understanding of laboratory hazards preferred. Experience supporting or leading FDA inspections, regulatory audits, or third-party certification audits preferred. Experience managing CAPA systems, deviation investigations, and out-of-specification (OOS) events in a pharmaceutical or regulated manufacturing environment preferred.

PHYSICAL REQUIREMENTS/ WORKING ENVIRONMENT

The work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Sit an average of 3-4 hours per day. Stand an average of 2-3 hours per day. Walk an average of 2-3 hours per day.

Required Movements:

Bend/Stoop - Rarely (1-2 times per day). Squat - Rarely (1-2 times per day). Reach above shoulder level - Rarely (1-2 times per day). Crouch - Rarely (1-2 times per day).

Weight Carried:

Up to 10 lbs - Occasionally (1-4 times per hour).

Weight Lifted:

Up to 10 lbs - Occasionally (1-4 times per hour). Hands Used for

Repetitive Action:

Simple/light grasping (right hand) - Frequently (5-24 times per hour). Firm/strong grasping (both hands) - Rarely (1-2 times per day). Fine dexterity (both hands) - Constant (more than 25 times per hour). Job requires being around moving machinery and equipment. Job requires wearing personal protective equipment as necessary.