Sr Manager of QA​/QC ( Supplements

We are looking for a driven, and detail-oriented Quality Control and Assurance Manager to join our growing team on our mission of becoming the #1 Gut Health brand in the US. This person will be responsible for leading our quality assurance and control function. This role is critical in ensuring the integrity, safety, and compliance of our dietary supplement products. This individual will work closely with Physician’s Choice internal and external stakeholders (including but not limited to marketing, quality, 3rd Party Suppliers, raw material suppliers, regulatory agencies, trade associations, etc.)

to support new product development, supply chain, and sales in commercializing new products that are safe, efficacious, high quality and compliant with all applicable regulations.

The ideal candidate will have deep knowledge of FDA regulations, GMP standards, and all regulatory requirements related to dietary supplements.

Quality Management System -

• Oversees the revision, preparation, and dissemination of new and updated compliance standards and procedures.
• Coordinates, supervises, and supports the establishment's compliance-related programs, such as compliance training, compliance testing and reporting, disaster recovery, contingency planning, and records warehousing and destruction.
• Write and review audit documentation, SOPs, and work instructions.
• Oversight of Specification Management, Document Control & Record Keeping, Product Inspection and Release, Analytical Testing, and Product Certifications
• Completion and trending of Supplier Non-Conformance Reports including the development and implementation of Corrective and Preventive Actions
• Facilitate Material Review Board meetings to provide dispositions for the release or rework of out of specification materials
• Conduct periodic audits of Contract Manufacturers, Raw Material Suppliers, 3rd Party Logistics, and Contract Laboratories.

New Product Development -

• Support new Product Development, Brand, Creative, and Marketing during the design and approval of new product packaging, product listing, and marketing materials that comply with applicable regulations

Consumer Complaint - Management

• Coordinate with Customer Service, Supply Chain, and co-manufacturers to drive consumer complaint reduction initiatives related to Adverse Events and Product Defects to identify and implement corrective and preventive actions.
• Identify complaint trends require root cause analysis and work with suppliers and co-manufacturers to develop and implement corrective and preventive action

Supply Chain and Sales - Support

• Support Sales with the registration and marketing of Physician’s Choice products in foreign markets
• Responsible for product certification and registration
• Coordinate with Sales to define and incorporate customer requirements into specifications and business processes
• Coordinate with Sales, Supply Chain, and Finance to ensure 3PL order fulfillment procedures ensure product delivered to customers meets requirements
• Coordinate with Sales, Supply Chain, and 3PL to drive customer complaint reduction initiatives to drive customer complaint reduction initiatives to identify and implement corrective and preventive actions
• Back-up and support Regulatory and Quality Manager, as needed.

• Bachelor's degree (B.
  
  A.) from four-year college or university in Science, Chemistry, Biochemistry, Pharmacology, Biology, Food Service or related field; or an equivalent combination of four to six years related experience and/or education/training are sufficient to successfully perform the key accountabilities of the job.
• 5+ years progressive Quality or Product Development experience in a cGMP or regulated manufacturing industry preferred.
• Experience following Good Manufacturing Practices (cGMP) Regulations, Code of Federal Regulations Title 21 Parts 100-199 and has extensive knowledge of the Dietary Supplement Health & Education Act (DSHEA)/Nutrition Labeling and Education Act (NLEA) Labeling Regulations, Code of Federal Regulations Title 21 Part 101 and the Food Allergen Labeling and Consumer Protection Act (FALCPA) Regulations.
• Technical writing…