Quality Assurance Manager

Sheffield Pharmaceuticals • New London, CT

4d

About The Position

The Quality Assurance Manager will be responsible for identifying and setting quality standards, overseeing investigations and corrective actions, ensuring compliance with regulations, designing quality systems, conducting training, supporting audits, and managing the QA staff. This role requires strong leadership, communication, and organizational skills, with a focus on maintaining compliance with cGMP, ICH, and USP standards within the pharmaceutical industry.

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
• Quality experience may include QA involvement, auditing or validation
• Strong verbal and written communication skills
• Strong interpersonal skills
• Ability to develop strong relationships with team members, co-workers, senior leadership, and regulatory agency representatives
• Ability to understand cGMP, ICH and USP guidance's and standards
• Well-developed organizational and time management skills
• 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
• Ability to master in-house programs and software

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager