Job Summary:

The Director of Quality Assurance and Regulatory Affairs is responsible for managing all QA functions, working with cross-departmental leadership to deliver high quality products on schedule. The Director will plan, direct, or coordinate production activities of the organization and ensures compliance with applicable regulations and standard operating procedures. This position will also be responsible for keeping up to date on government and industry regulations, rules and analyzing federal, state, and local regulations to determine how they apply to the company’s operation and policies.

Quality Assurance responsibilities:

• Establishes quality and reliability standards by studying product and consumer requirements with other members of management and with production operators, technicians, and engineers.
• Reviews, Updates and Corrects existing processes and protocols as needed
• Responsible for supervising, training, scheduling, and monitoring the duties and activities of Quality Assurance personnel. Initiate communication with Production Manager, Quality Control, and CEO as well as customer as required and when necessary.

• Implements in-process product inspection standards by studying manufacturing methods and devising testing methods and procedures.

• Improves and creates product quality documentation system by writing and updating quality assurance procedures
• Assured quality products and processes by establishing and enforcing quality standards and testing materials and products
• Communicate and work with department managers to resolve issues in areas of concern and review and modify procedures as required.
• Trouble shoots Quality Assurance issues throughout the plant, making recommendations for corrective action, when necessary.

• Maintains product quality by enforcing quality assurance policies and procedures and government requirements.
• Oversee all plant HACCP, quality and safety programs, processes, safety and regulatory and or customer requirements.
• Manages quality assurance staff job results by coaching, counseling, and disciplining employees.
• Ensures quality by planning, monitoring, and appraising job results.
• Point of contact to the regulatory manager, EPA and other regulatory agencies as needed

Regulatory Affairs responsibilities:

• Develops strategies to ensure the company’s production activities comply with government regulations.
• Serves as a liaison between regulatory bodies and operating divisions of the company.
• Coordinates with operations departments regarding production design and development to ensure compliance with regulations.
• Maintains current knowledge of relevant regulations applicable to the company.
• Monitors regulatory affairs and the effect changes will have on the company operations.
• Coordinates inspections of the organization and contract facilities and develops procedures to ensure regulatory compliance.
• Investigate product complaints and prepare documentation and submission to appropriate regulatory agencies, as necessary.
• Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
• Provide regulatory input to product lifecycle planning.
• Prepares for, organizes, and oversees the appropriate internal and external audits and inspections.
• Performs regulatory review of labeling, manufacturing, and communications documents, and clinical protocols for regulatory compliance.
• Perform other special projects and additional tasks assigned

Required Skills/Abilities

• Attention to detail and deadline driven
• Ability to interface with and effectively communicate with customers, cross functional teams, as well as management.
• Must have excellent organizational, inter-personal, verbal, and written communications skills
• Extensive knowledge of applicable government regulations.
• Ability to inform and educate managers and department heads on regulations and policies that require compliance.
• Professional written and verbal communication skills
• Strong research, writing, and computer skills

Education and Experience

• Bachelor’s degree in Business Administration, Environmental Safety, Chemistry, or related field required, Master’s degree desirable.
• Have working knowledge and experience working with EPA, OSHA and other local agencies
• Experience working in a liquid/wet wipes manufacturing facility a plus!
• Desired knowledge of ISO, cGMP, and FMCG procedures
• 7 years of related work experience.