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…