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QUALITY ASSURANCE DIRECTOR

SCOPE:
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.

RESPONSIBILITIES:

• 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.

QUALIFICATIONS:
• 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 history.

No phone calls please.

Argos Therapeutics is an Equal Opportunity Employer.