Quality Assurance Manager

A midsized pharmaceutical company based in Waltham, MA is looking to hire for a Manager of Quality Assurance. As the Quality Assurance Manger, you must be a subject matter expert in validation documentation processes. These processes include but are not limited to; compliance of Good Documentation Practices, Quality System Implementation, & Data Integrity. This role is integral for the growth of the company and will report directly into the Head of Quality.

Job Responsibilities:

• Review and approve validation documentation generated for the company environment.
• Execute protocols, scripts, deviations, incidents, change controls, and system design specifications.
• Provide quality system guidance/training to the engineering staff and more junior quality colleagues to ensure compliance to GxP standard and processes.

Skills and Requirements:

• Bachelor's degree in Science. Master's degree in Science related field strongly preferred
• Minimum of 6 years of Pharmaceutical industry experience with at least 4 of those years working directly in documentation and Quality Assurance
• Strong validation and/or qualification experience - ie, IQD, OQD or PQD
• Ability to clearly communicate with customers & team on a regular basis
• Hands on experience with CAPA, Change Control (including emergency changes), Deviation, incidents, and validation documentation (IQ/OQ/PQ).
• Excellent communication skills are required. The QA Manager will, at times, be client facing and will be responsible for conducting quality trainings to the engineering staff to ensure GxP compliance.

If you are having difficulty in applying or if you have any questions, please contact Tom Maino at (+1) 646-693-0610 or t.maino@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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