Quality Assurance Manager - Pharmaceutical Manufacturing

Responsibilities

• Identify and set appropriate quality standards, and communicate standards and parameters to team and other staff/departments as appropriate
• Oversee investigations to effectively identify root cause and develop strategies to deploy corrective actions as required
• Maintain strict compliance with state, federal, local and organizational laws, regulations, guidelines, procedures and policies
• Ensure good documentation practices are deployed and maintained
• Design quality systems that comply with regulations and cGMP
• Conduct or oversee cGMP training for all departments and establish training goals for QA department members
• Support regulatory and customer audits as well as any related actions required
• Develop and deploy strategies for effective internal and external audits as required
• Execute review and release of finished goods
• Hire, train and develop QA staff
• Oversee daily workflow and department scheduling
• Conduct timely and constructive performance evaluations for team members
• Handle coaching, counseling, and disciplinary action where needed, and in accordance with Company policy

Requirements

• Relevant four-year college degree
• Minimum of 8 years of proven success in a supervisory/management role
• Minimum of 5-10 years of QA experience in the pharmaceutical industry (may include QA involvement, auditing or validation)
• Strong verbal and written communication skills, interpersonal skills, and the ability to develop strong relationships with team members, co-workers, senior leadership, and regulatory agency representatives
• Understanding of cGMP, ICH and USP guidance and standards
• Well-developed organizational and time management skills, as well as the ability to effectively articulate, receive, and analyze information as required
• Strong leadership skills, including team accountability, motivation, coaching and development, and succession planning
• Highly computer literate with proficiency in Microsoft Office Suite, and the ability to master in-house programs and software