Quality Systems Manager

Proclinical is currently recruiting for a Quality Systems Manager with a pharmaceutical company located in Boston, MA.

Job Responsibilities:

• Lead Functional Subject Matter Experts to define aligned processes for QS performance data collection, report, assessment and manage risks identified.
• Manage the implementation of key Continuous Improvement projects as needed.
• Implement and maintain processes aligned with applicable policies and standards to report on QS performance data, including monitoring of key leading and lagging indicators of QS performance as well as product performance.

Skills and Requirements:

• Bachelor's degree in biostatistics, life sciences or related field with strong background in statistics
• 4 to 8 years of experience in biopharmaceutical/pharmaceutical or related industry with strong background in statistics, data analytics or continuous improvement.
• Hands-on experience as a project manager.
• Lean/Six Sigma Green Belt certification
• Thorough knowledge of cGMPs, GXPs and Quality Systems required
• Advanced quality certification strongly desired (i.e., Six Sigma Green Belt, Certified Lean Expert, etc.).

If you are having difficulty in applying or if you have any questions, please contact Janelle Jones at 617-830-7544.

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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