Manager, Quality Assurance

Qualifications/Requirements:

Minimum of Bachelor’s degree in a scientific discipline with five to seven years’ experience in a cGMP regulated pharmaceutical/biotech environment

• Strong knowledge of appropriate Quality Systems and cGMPs (FDA, EU, ICH) with the ability to assess compliance risks
• Demonstrated ability to work independently and remotely, prioritize, problem-solve and complete activities in a timely manner without daily direction from the Head of Quality or others.
• Strong verbal skills, technical writing skills and ability to work with others in a collaborative manner.
• Ability to anticipate and mitigate challenges and apply a flexible risk-based approach to problem solving
• Experience with Microsoft Office is preferred

Preferred Experience, Special Skills and Knowledge -

 

• Expertise and hands-on knowledge of GMPs
• Entrepreneurial, innovative, analytical, and solution-minded
• Proficiency in SharePoint, MS-Word, Excel, PowerPoint, Adobe Acrobat, and Veeva