8+ years in supervisory/management roles essential.
5-10 years of QA experience in the pharmaceutical industry.
Strong verbal and written communication skills necessary.
Understanding of cGMP, ICH, and USP standards is a must.
Demonstrated leadership skills required, including team motivation and development.
High proficiency in Microsoft Office and ability to learn new software.
Responsibilities
Identify and communicate quality standards to team and staff.
Oversee investigations to determine root causes and corrective actions.
Ensure compliance with all relevant regulations and policies.
Maintain documentation practices effectively.
Design quality systems that meet regulatory requirements.
Conduct cGMP training and establish training goals for QA staff.
Support and prepare for regulatory and customer audits.
Benefits
Opportunities for professional development and training.
Collaborative work environment.
Supportive leadership encouraging innovation and accountability.
Strong focus on compliance and quality in operations.
Full Job Description
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
