Director, Quality

SUMMARY DESCRIPTION

The Director of Quality & Technical Services will be responsible for production support, scaleup and the technology transfer of new and ongoing formulations as well as quality assurance and control oversight to ensure that quality systems and regulations are in place and being adhered to for the production of Cosmetic, Household, and OTC products. They will work with various teams to ensure compliance with internal policies and procedures, and industry best practices under the direction of the VP Technical Services..

PERFORMANCE EXPECTATIONS

The Director of Quality & Technical Services is responsible for R&D, Scale Up, and Quality. The role is primarily the main technical point of contact supporting the manufacturing and sales teams. Essential duties and responsibilities include the following:

• Support Quality Assurance, Quality Control, and R&D with the technical knowledge to complete their tasks.
• Reviews and ensures batch records and instructions are ready for Manufacturing scale-up and insures pilot batch and scale up support
• Is responsible for the filing of all applications, permits and forms to keep the Company in compliance with state, local and federal government regulations pertaining to chemical use at the site.
• Be responsible for managing third party testing of products associated with FDA-OTC requirements. This includes approving protocols, reviewing/approving reports and keeping paper and electronic records of testing documents.
• Be responsible for maintaining lab housekeeping practices to insure we meet and/or exceed minimum requirements of FDA, NOP NPA and cGMP.
• Upgrading and maintaining the Quality Management System.
• Assists Purchasing as appropriate with the identification and qualification of vendors.
• Manage quality compliance programs to ensure issue resolution and success
• Lead and participate in formal problem-solving processes, conduct root cause analysis and corrective action investigations.
• Lead all audit preparation activities and participate in regulatory authority audits.
• Perform miscellaneous job-related duties as assigned.
• Maintains awareness of changes in policies, procedures and protocols • Lead and participate in companywide compliance efforts, ensure compliance, and support all facets of the Quality Management System
• Complies with company policies and procedures.

ESSENTIAL FUNCTIONS

• Serve as subject matter expert in support production scale-up and quality activities performed at or on behalf of the company.
• Assure all systems, processes, procedures, and policies (and all outcomes) are fully compliant (regulations and standards, directives, policies, and best practices).
• Oversee the internal and external audit program, which includes focus on GMP and regulatory compliance
• Manage the quality management system within the company to ensure all federal and international standards/regulations are satisfied.
• Review quality metrics. Analyze data relating to process validations, process controls, and continuous process improvement efforts. Coordinate necessary quality adjustments.
• Oversee the following investigations: nonconforming product, customer complaint, laboratory out-of-specification, corrective and preventive action, and recall program.
• Ensure all investigations are performed and closed in a timely fashion. Monitor and report adverse events.
• Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, company procedures, and policies.
• Develop and work with staff to implement quality process controls relating to all areas of operation, including the following systems: quality, facilities and equipment, materials management, production, packaging, and labeling.
• Review, trouble shoot and address batch records to meet production needs.
• Lead a cross-functional risk management program and provide updates for management review.
• Develop and measure metrics (KPIs) to drive continuous improvement in quality.
• Manage facility-wide training initiatives and document control systems.
• Participate in or lead teams for special projects as assigned.
• Taking on extra tasks in order to support the President/CEO needs of the company.

WORK EXPERIENCE

• Manufacturing or Pilot Facility work experience.
• 10+ years’ experience working in a GMP environment in manufacturing industry.
• Minimum of 15 years’ experience in cosmetic and OTC product quality and production scale-up.
• Strong knowledge of personal care formulations (surfactants, gels, emulsions).
• Experience with microbiological test methods is a huge plus
• 5+ years’ Management Experience preferred. • 3+ years’ Quality and Regulatory Experience

QUALIFICATIONS

• Bachelor’s degree in chemistry, Biochemistry, or a Biological Science related area of study (Experience in microbiology a plus)
• Master’s of Science in Chemistry preferred (or equivalent experience)
• 10+ years of experience in cosmetic and OTC products (manufacturing experience preferred)
• 10+ years of experience in Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) quality.
• Experience managing customers, external facility quality audits, and quality systems. • Strong analytical skills with the ability to work both independently and in a team environment.