Quality Assurance Manager Waltham
We are seeking a Quality Assurance Manager to oversee the quality control and quality assurance activities for our pharmaceuticals research division. The successful candidate will work closely with research and development teams to ensure that all research activities are performed in accordance with current Good Manufacturing Practices (cGMP) and other regulatory requirements.
- Develop and maintain a comprehensive quality control program for pharmaceuticals research activities
- Establish and maintain Standard Operating Procedures (SOPs) for all quality control activities
- Conduct audits and assessments of research activities to ensure compliance with cGMP and other regulatory requirements
- Ensure that all research activities are properly documented and that data integrity is maintained
- Collaborate with research and development teams to identify areas for improvement and develop corrective and preventive actions
- Serve as the primary point of contact for regulatory agencies and auditors during inspections
- Develop and deliver training programs for research and development teams on cGMP and other regulatory requirements
- Maintain up-to-date knowledge of relevant regulations and industry best practices
- Bachelor’s or Master’s degree in Chemistry, Biochemistry, or related field
- 5+ years of experience in Quality Assurance in the pharmaceutical industry
- In-depth knowledge of cGMP and other regulatory requirements for pharmaceutical research and development
- Proficient in Microsoft Office Suite
We offer a competitive salary, benefits package, and a dynamic and collaborative work environment. Quality Assurance candidates with a passion for ensuring the quality of pharmaceutical research and development are encouraged to apply.
EEO – M/F/D/V