Director of Quality

Position Summary 

The Director of Quality will be responsible for the development, implementation, and execution of processes that inspect and improve the quality of products. The Director ensures that the products meet and exceed standards set by customers and any regulatory bodies for cosmetic and OTC products through the design, adherence, and enforcement of quality processes. The position manages a team including members of Quality Control, Quality Assurance, and Microbiology. These teams support the execution of testing, improvement, and disposition throughout the plant. The director is responsible for development of KPIs that drive performance and evaluation based on those metrics. The position ensures the alignment of department execution that supports the company goals and strategic initiatives while ensuring regulatory compliance. As head of the Quality department, the position sets the standard for quality throughout the company and drives the quality culture. The Director develops and manages the budget for their teams and provides the framework for ensuring a robust integration of quality throughout the development, production, and supply chain processes.

Responsibilities and Essential Duties

• Ensure the integration of Quality in all steps of the development, manufacturing, and supply chain process.
• Train and develop the Quality Team.
• Manage the Quality team to improve and enforce quality standards through QA, QC, and Microbiology.
• Design and develop new quality control processes to improve efficiency and consistency including testing, inspection, and production.
• Interact with Regulatory bodies, such as the FDA, to ensure compliance.
• Develop, review, and approve SOPs that meet and exceed Quality standards set forth in specifications for incoming raw materials, outgoing finished goods, and work-in-process materials.
• Execute internal audits and guide third-party audits.
• Ensure a robust training framework based on cGMP, internal audits, and CAPAs.
• Support the Company’s mission, values, and standards of ethics and integrity by incorporating these into the development and implementation of business plans.
• Set and maintain department goals and timelines (Key Performance Indicators).
• Drive Robust Notice of Event (NOE) investigations and CAPAs for Quality issues that arise.
• These responsibilities can and will change as we continue to grow.

Technical Skills Required

• Must possess strong technical skills. Certification by ASQ, as a CQM/OE is strongly preferred.
• Must have exceptional knowledge of FDA regulations and Good Manufacturing Practice (GMP) regulations, along with excellent decision-making skills to determine risk assessments and provide the most efficient utilization of resources to accomplish departmental objectives.
• Excellent oral and written communication, change management, and leadership skills are required to interface with all levels of management and to coach, train, and motivate staff.
• Must possess excellent project management skills to coordinate multiple projects and adhere to tight timelines while working with people at all levels of the organization.
• Must be self-motivated and possess strong problem-solving and critical thinking skills.
• Must have excellent interpersonal and leadership skills to effectively meet objectives. • Computer skills to include proficiency with Microsoft Office software.
• Understanding of cGMP and FDA CFR 21 Parts 210/211.
• Self-directed and motivated.
• Collaborative and team oriented.

Experience Required

• Bachelor’s Degree.
• 10 or more years prior work experience in CPG or Pharmaceutical industry, contract manufacturing preferred.
• Experience in developing and managing budgets.
• Experience in managing and developing a team of at least 10 people. 

Physical Requirements

• Regularly sit, stand, and walk for extended periods of time.
• Ability to sit, balance, climb, stand, bend, squat, squeeze, kneel, turn, crouch, stoop repeatedly.
• Physically able to lift 50 pounds periodically.
• Frequent exposure to varying temperatures, loud noises, heavy machinery, fumes, airborne particles, moving mechanical parts, electrical current, chemicals, and vibrations.
• Prolonged use of computer screen.