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QUALITY ASSURANCE DIRECTOR
This person will oversee areas of Quality Assurance and Regulatory Compliance for the manufacture of autologous immunotherapeutics including audits, training programs, data and documentation reviews and analysis, preparation of SOP´s, and other projects as necessary.
• Manage Quality Assurance functions to include hiring, training and development of QA personnel for the maintenance and establishment of Quality and Regulatory systems.
• Oversee review and drafts of SOPs, protocols and final reports. Ensure that QA SOPs and cGMP documentation for areas of responsibility are adequate and current.
• Work collaboratively with other departments to ensure compliance with cGMP processes and safety procedures for biologics manufacturing and readiness for regulatory inspections.
• Review and approve completed batch records, test results, investigations and change control. Release final product for clinical use to meet project goals.
• Conduct internal and external audits of manufacturing operations, testing laboratories and suppliers.
• Manage critical raw material files and raw material quarantine and release program.
• Manage company-wide cGMP training program.
• Participate in Steering Committees and Planning Committees on relevant technical programs.
• Stay abreast of QA and regulatory areas and communicate changes and issues to all levels of the organization.
• Oversee discrepancy, corrective and preventive action (CAPA) and change control systems.
• Participate on project teams for the design of new systems and procedures.
• Oversee equipment validation/calibration activities.
• Oversee the resolution of complex QA issues related to autologous immunotherapies.
• Assist Manufacturing to ensure production processes comply with appropriate FDA and Country specific regulatory requirements (Health Canada).
• Assist in technology transfer from R&D; and Process Development (Automation) to GMP manufacturing under batch records and appropriate FDA and Health Canada regulatory compliance.
• Assist in facility expansions for manufacture and other operations that meet the FDA and Health Canada regulatory requirements.
• Work as an effective team member with others in Operations and R&D; to identify and accomplish company objectives.
• Other duties as required.
• B.S. Degree in scientific discipline, preferable biology or chemistry, Master´s or Ph.D. preferred; and 10 years relevant biotech industry experience in a cGMP environment. Must have at least 3 years management or supervisory experience.
• Previous experience overseeing QA at a biologics manufacturing facility (early stage, pre-clinical) is required. Specifically, must have 5+ years´ experience in biologics.
• Experience in human cellular immunology and experience in the development of cellular vaccines is a plus.
• Expert knowledge of cGMPs and guidance regulations for the manufacture of biological products and how these regulations are applied to the manufacture, testing and release of biological product.
• Previous QA management responsibilities must include cGMP production, preparation for and management of regulatory inspections, internal and external auditing, CAPA, batch record review, review & approval of reports and documents prepared by QA, raw materials sampling & release and management of departmental budget. Familiarity with electronic document handling systems would be helpful.
• Must have experience auditing to GMP/GLP standards and writing and maintaining controlled documents.
• Previous experience assisting in the establishment of a quality system and development of corporate level policies and procedures.
• Proven ability to effectively supervise staff and manage priorities; excellent communication and influencing skills; and ability to work collaboratively within and across groups.
• Excellent attention to detail.
We offer a competitive compensation package along with outstanding benefits.
For confidential consideration, please
a resume with a cover letter and salary
No phone calls please.
Argos Therapeutics is an Equal Opportunity Employer.