Sr. Manager of Quality Assurance - QAGMP

The Sr. Quality Assurance Manager is primarily responsible for establishing and maintaining the quality systems for the entire production process relating to record review and release, corrective actions, exceptions, training, document management and regulatory compliance.

• Oversee quality assurance programs, processes and facilities by ensuring regulatory compliance in the manufacture of products from beginning to end
• Oversee training program by ensuring training requirements for all employees align with established training curricula and support job descriptions
• Identify training and development needs for each department and support personnel with design, presentation, evaluation, and revision of training programs
• Develop and implement a system to manage change control, OOS’s, deviation and product complaints
• Ensure comprehensive technical and administrative review of the batch and analytical data generated by manufacturing and GMP test laboratories
• Participate in investigations and corrective action identification and implementation process for OOL and Exceptions
• Ensure on-time closure of corrective action/preventive action items
• Implement GMP training program for company employees
• Establish trending program for quality metrics including CAPA and PPQE
• Ensure new CMOs are assessed for GMP compliance and certified prior to supply of services and or goods

Qualifications:

• BS Degree in a Life Science (Advanced degree and/or Quality certification preferred
• 10+ years in pharmaceutical QA (GMP focus)
• Must have the ability of managing complex projects and resolving complex issues
• Possess excellent supervisory, interpersonal, leadership, project management skills
• Must possess confidence and be able to communicate with all levels of personnel and regulatory authorities
• Strong understanding of biotechnology pharmaceutical industry
• Must have extensive background using third party vendors and CMOs
• Proven experience leading regulatory inspections including hosting, follow up and close out