The Position: This position is Quality Assurance Manager within the Quality group of CMO.
SUMMARY: The Quality Assurance Manager is a key role for upholding the organization's commitment to quality and compliance. Acts as a custodian of cGMP compliance and Regulatory. Promotes high quality standards to ensure clients are compliant with all regulatory agencies' guidance and regulations including the US FDA, international pharmaceutical regulatory agencies, and State authorities.
Location: Milwaukee, WI (Onsite)
REPORTS TO: Director Quality and Regulatory Affairs PRINCIPAL RESPONSIBILITIES: Creates, implements, and maintains company high quality standards. Accomplishes quality assurance objectives by monitoring, reviewing, and enforcing policies and procedures. Maintains and improves product quality by completing product, company, quality system, and compliance audits. Drives classic QA activities with external and internal partners, including: Audits Deviations OOS (Out of Specification) Change controls system Quality management system Quality agreements Vendor qualifications Filling with and responding to regulatory bodies, including managing DMF and VMFs. Managing 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 is 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. Fluency in English with strong IT and organizational skills. Oversight of Food & Flavor and Nutraceutical Products' quality and regulatory activities, including interacting with representatives of related food/flavor/nutraceutical agencies and the Kosher Council rabbi. Familiarity with FSMS (Food Safety Management System). Following all applicable instructions relating to food safety and the FSMS, including employee GMPs. Reporting food safety problems to personnel with the authority to initiate actions. JOB DESCRIPTION: 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 products along with labeling. Authoring or editing SOPs, drafting, reviewing, and approving investigations (deviations, customer complaints, etc.). Providing information and documentation responses in cases of customer complaints or returns. Authoring, reviewing, and approving equipment IQ/OQ protocols (or other protocols). Interacting with customers and potential customers regarding products, specifications, and returned products. Ensuring compliance of the department and company with regulatory requirements and enforcing adherence to procedures and policies. Establishing and maintaining an 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 and driving cGMP compliance. Conducting cGMP training for all levels of employees. Providing Purchasing assistance by executing raw material and new customer evaluations. Communicating effectively with all levels of management to meet customer purchasing needs. Leading internal compliance inspection system, including maintenance of the schedule, performing inspections, writing reports, and performing follow-ups in a timely manner. Leading external compliance audits, including maintenance of the schedule, performing inspections of external suppliers, writing reports, and performing follow-ups in a timely manner. Other related duties as assigned by the Director of Quality and Regulatory Affairs. QUALIFICATIONS: 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. Onsite Milwaukee, WI.
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