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Quality Assurance Strategist

Waltham, MA, United States

Job Summary: Quality Assurance Strategist

Regulatory and Quality Compliance Oversight

• Experience with (but not limited to) the following U.S. and global regulations: o 21 CFR Part 58 GLP o ISO 9001, ISO 17025

• Experience with biopharma services including CDx/IVD applications.

• Support QMS strategy and tactics.

IND Submission Experience

• Develop plan and provide regulatory and quality oversite to define what would be required to support IND submissions with customers.

Audit Support

• Conduct internal audit to identify potential compliance deficiencies and mitigate risk to the company and its customers.

• Provide audit readiness and real-time audit support.

Customer Report Review

• Ensure reports and associated data generating activity complies with 21 CFR Part 58, GLP.

• Review customer reports for accuracy, completeness, clarity, and sign off on activities documented in the quality summary.

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