Quality Assurance Manager - Pharmaceutical Manufacturing

Quality Assurance Manager

KEY 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

QUALIFICATIONS:

• Candidate must have a relevant four-year college degree and a minimum of 8 years of proven success in a supervisory/management role.
• Candidate must also have a minimum of 5-10 years of QA experience in the pharmaceutical industry. Quality experience may include QA involvement, auditing or validation.
• Must possess 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
• Must be able to understand cGMP, ICH and USP guidance's and standards
• Must have well-developed organizational and time management skills, as well the ability to effectively articulate, receive, and analyze information as required
• Must demonstrate strong leadership skills, including team accountability, motivation, coaching and development, and succession planning
• Must be highly computer literate with proficiency in Microsoft Office Suite, and the ability to master in-house programs and software

Sheffield Pharmaceuticals is an Equal Employment Opportunity employer. We provide equal opportunity to employees and applicants for employment without regard to race, creed, color, religion, sex, age, national origin, physical or mental disability, sexual orientation, marital or familial status, genetic information, protected veteran status, or other basis protected by law.