Manager of Quality Assurance and Compliance

POSITION SUMMARY:

The Manager of Quality Assurance and Compliance is responsible for ensuring the quality and regulatory compliance of all raw materials, packaging components and products in the company’s US facilities, China facilities, and other qualified contractors. The Manager of QA/C must ensure standards are met through independent approval of trial results, prototype samples, and finished product samples.

Additionally, the Manager of QA/C acts as an advisor in identifying and solving complex QA problems, approves and distributes test plans, determines whether protocols meet minimum legal standards, approves pilot and commercial production lots based on a review of batch records and QC test results, and provides technical, regulatory, QA, and GMP assistance to our clients.

MAJOR RESPONSIBILITIES:

• Serve as partner to other functional areas, e.g. Product Development, Purchasing, Manufacturing, and Operations.
• Select teams, establish timelines, and conduct qualification and compliance audits of suppliers, manufacturing and distribution facilities, and R&D facilities.
• Monitor the activities of quality engineers and associates at the  company’s China facility to ensure regulatory compliance for each product category (food, nutritional supplement, device, cosmetic, household products, etc.) This monitoring includes the following:
o Review and approve specifications and standards for raw materials, packaging components, product and manufacturing processes, and applicable SOPs.
o Review and approve label copy for technical accuracy and regulatory compliance.
o Distribute quality, procedures, standards and specifications to all participating functions.
o Review analytical and microbiological testing protocols to ensure they meet all industry and legal standards.
o Design, catalogue, approve, and distribute test plans and protocols to all participating functions.
o Review and approve test results from Manufacturing Quality Control.
o Investigate quality control failures and advise R&D and Manufacturing groups.
o Investigate consumer complaints related to quality control failures and respond accordingly. Track PER trends and report them to management.
o In the event of a major quality control failure with a distributed product, conduct in-depth investigation, notify senior management, and initiate appropriate action (product hold or reject, market withdrawal, or full recall).
o Establish and monitor the CAPA programs at contract manufacturer and the company’s facilities to ensure that all non-conformances are addressed and that adequate corrective action is taken as necessary.
o Approve pilot plant trial batches, clinical batches, and all production batches in the China and contract manufacturer facilities.
• Communicate with related regulatory and licensing government agencies. Update and maintain all licenses and registrations.
• Administer GMP training program, conduct training sessions as required, and maintain training database.
• This person shall be held accountable for:
1) Ensuring that procedures and specifications defining quality expectations are in place
2) Ensuring the quality and regulatory compliance of all materials purchased, processed,and distributed the company and contractor facilities, including those items produced in the  U.S. for the company’s International operations
3) Ensuring all quality assurance testing activities are performed per defined protocolsand are reported in a timely manner to support R&D, Product Management and  Manufacturing.

 
POSITION REQUIREMENTS:

• Knowledge of GMP regulations for FD&C products and corresponding industry standards
• Practical understanding of statistical methods
• Extensive management experience in R&D and manufacturing environment, and in interacting with Product Management, Legal, and Field Support
• Strong technical expertise in all areas of the company business
• Proven competence in dealing with internal processes and personnel
• Excellent critical thinking, strategic and analytical skills as well as a holistic approach to problem solving and decision-making
• Excellent organizational skills and ability to perform multiple, overlapping tasks
• Ability to effectively communicate with senior management
• Must possess excellent oral, written and listening skills in English
• Positive attitude and excellent interpersonal skills
• Proven competence in creating, administering, and managing budgets
• Ability to analyze present processes to accurately predict and manage future needs
• Understanding of network (or multilevel) marketing preferred
• Good physical health; must be able to travel by car or air on short notice and be able to access equipment in a factory environment
• Ability to resolve complex technical and regulatory issues and work long hours to support changing business requirements
• Knowledge of computers, word processing, spreadsheet and statistical programs
• Must work well with others
• Must work well under pressure• Minimum of 5 years of experience in Quality Assurance/Compliance experience and management experience in the FD&C industry,  Product Development, and all functions within Operations
• Bachelors or Masters degree in pharmaceutics, food, chemistry, microbiology, or engineering

•Understanding of quality technology, preferably with ASQ certification (CQE or CQM)