Quality Assurance Manager
Sheffield Pharmaceuticals•New London, CT
•Onsite
About The Position
Sheffield Pharmaceuticals is seeking a Quality Assurance Manager to oversee quality standards, investigations, and compliance within the organization. This role involves designing quality systems, supporting audits, managing a team, and ensuring adherence to regulatory requirements like cGMP, ICH, and USP. The manager will be responsible for training, performance evaluations, and daily workflow management of the QA department.
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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
