Quality Assurance Manager


St. Francis, WI



  • Creates and implements and maintains company high quality standard
  • Accomplishes quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures.
  • Maintain and improves product quality by completing product, company, quality system, and compliance audits.
  • This role drives the classic QA activities with external and internal partners: Audits, deviations, OOS, change controls system, Quality management System, quality agreements and Vendors qualifications as well as filling with and responding to regulatory bodies, such as manage DMF, VMFs.
  • Manage the QA aspects of a network of suppliers and co-development partners to ensure compliance.
  • Thorough knowledge of global GMP requirements for all phases of product development through commercialization; pharmaceutical development/manufacturing as a plus
  • Experience in planning and conducting internal and external audits and regulatory agency inspections, and negotiating and implementing quality agreements
  • Ability to work both independently and as part of a team
  • Familiar with FSMS (Food Safety Management System). Follow all applicable instructions relative to food safety and the FSMS, including employee GMPs.
  • Report food safety problems to personnel with the authority to initiate action
  • Assists in the successful execution of customer and agency audits.
  • Batch record review and approval as well as Quality Assurance support and documentation review and approval
  • Authority to approve, release, reject or hold raw materials, packaging and finished product along with labeling.
  • Authoring or editing SOPs, drafting, reviewing, and approving investigations (deviations, customer complaints, etc.)
  • Provide information and documentation responses in cases of customer complaints or returns.
  • Authoring, reviewing and approving equipment IQ/OQ protocols (or other protocols).
  • Interacts with customers and potential customers, as required, regarding products, specifications, and returned products.
  • Ensure compliance of the department and the company with regulatory requirements and enforces following of procedures and policies. Establish and maintain the environment of consistent compliance with procedures, both internal and regulatory, through training and guidance and review of procedures.
  • Ensuring compliance with cGMP regulations plant wide. Drives cGMP compliance. Conducts cGMP training for all levels of employees.
  • Provide Purchasing assistance by executing raw material and new customer evaluations.
  • Communicate effectively with all levels of management in order to meet customer’s purchasing needs.
  • Lead for internal compliance inspection system including maintenance of the schedule, performing inspections of the plant and labs, writing reports, and performing follow-up in a timely manner.
  • Lead for external compliance audits including maintenance of the schedule, performing inspections of external suppliers, writing reports, and performing follow-up in a timely manner.
  • Other related duties as assigned by the Director of Quality and Regulatory Affairs.


  • Bachelor’s Degree in the life sciences or equivalent, with 10+ years of QA experience according to GMP at a biotech/pharma organization
  • A passion for CMO management and product quality
  • QMS: Regulatory filing and Responses with Global Reg bodies
  • Audits
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