QUALITY ASSURANCE MANAGER Argos Therapeutics
THIS JOB HAS EXPIRED SCOPE:
Under the direction of the CEO and COO, oversees the development, implementation, and maintenance of quality assurance systems and activities. This person manages the activities of personnel in the Quality Assurance (QA) and Document Management and Control (DM&C).
? Manage Quality Assurance and Document Control functions to include hiring, training and development of QA and DMC personnel for the maintenance and establishment of Quality, Document Control and Regulatory systems.
? Keep senior management informed and aware of the identification and resolution of compliance issues (i.e., CEO, COO, Directors)
? 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.
? Develop and implement programs to ensure compliance with applicable FDA/Health Canada/EU regulations and other agency requirements (GCPs, GMPs, GLPs, gene therapy, cell therapy, biologics, etc.)
? Oversee discrepancy, corrective and preventive action (CAPA) and change control systems. Manage the planning, development, implementation of document management policies for the company to support research, IND submissions, and manufacturing activities, and ensure compliance with document management regulatory concerns
? Ensure compliance during technology transfer from R&D and Process Development (Automation) to GMP manufacturing.
? Manage practices within the Document Management and Control Department to maintain a thorough and organized centralized document management system, which will standardize filing, protecting, retrieving records, reports, and other information contained on paper, computer programs, or other media
? Manage the Supervisor of Document Control relative to document management electronic system(s).
? 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.
? Participate on project teams for the design of new systems and procedures.
? Act as an advisor to other department employees regarding quality compliance issues
? Chair Material Review Board meetings
? Other duties as required
? BS/Masters degree in a scientific discipline or equivalent. 10+ years of related experience with BS degree or 7 to 10 years of experience with a Masters degree
? Must have experience auditing to cGMP standards and offering recommendations for adhering to Compliance standards
? Ability to analyze data and to assess and assist in resolution of extremely complex problems
? Working knowledge of scientific principles a must
? Demonstrated ability to effectively supervise staff and manage priorities; excellent communication and influencing skills; ability to work collaboratively within and across groups
? Strong interpersonal skills with the ultimate goal of gaining cooperation of others
? Demonstrated initiative and attention to detail
? Demonstrated ability to multitask and meet deadlines
? Ability to contribute to cross-functional teams while providing independent judgment regarding compliance issues
? Must have strong computer skills, primarily in Microsoft Word
? Willingness to travel up to 20% of the time
||4233 Technology Drive |
Durham, NC 27704
THIS JOB HAS EXPIRED