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Senior GxP Regulatory Compliance Lead Location- Cambridge, MA
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Job Title- Senior GxP Regulatory Compliance Lead
Location- Cambridge, MA *(Hybrid & Travel is required)
Job Summar: The Senior Compliance Validation Lead will be responsible for the 521 assessment, validation, and qualification of SOPs and Guidelines, as well as the development and implementation of Infrastructure Qualification SOPs, Templates, and Frameworks. This role requires a deep understanding of ALM, Veeva, and Service Now platforms, with a strong emphasis on Risk Assessment, Gap Assessment, Audit Findings, and fit-for-purpose assessments.
Key Responsibilities:
Conduct 521 assessments, validation, and qualification of SOPs and Guidelines to ensure compliance with regulator standards.
Excellent understanding of Pharma GXP assessment framework, FDA predicate rules, SLC Harmonization, and Periodic reviews.
Develop and maintain Infrastructure Qualification SOPs, Templates, and Frameworks.
Utilize knowledge of ALM, Veeva, and Service Now to enhance compliance processes.
Perform Risk Assessments and Gap Assessments to identify and mitigate potential compliance risks.
Address Audit Findings promptly and effectively, ensuring all compliance issues are resolved.
Conduct Fit for Purpose assessments to ensure all compliance tools and processes meet the required standards.
Conduct 521 assessments, validation, and qualification of SOPs and Guidelines to ensure compliance with regulator standards.
Excellent understanding of Pharma GXP assessment framework, FDA predicate rules, SLC Harmonization, and Periodic reviews.
Develop and maintain Infrastructure Qualification SOPs, Templates, and Frameworks.
Utilize knowledge of ALM, Veeva, and Service Now to enhance compliance processes.
Perform Risk Assessments and Gap Assessments to identify and mitigate potential compliance risks.
Address Audit Findings promptly and effectively, ensuring all compliance issues are resolved.
Conduct Fit for Purpose assessments to ensure all compliance tools and processes meet the required standards.
Qualifications:
Proven experience in compliance validation and qualification within a regulated environment.
Familiarity with ALM, Veeva, and Service Now platforms.
Strong analytical skills to perform Risk Assessments and Gap Assessments.
Ability to address and resolve Audit Findings efficiently.
Experience conducting Fit for Purpose assessments.
Proven experience in compliance validation and qualification within a regulated environment.
Familiarity with ALM, Veeva, and Service Now platforms.
Strong analytical skills to perform Risk Assessments and Gap Assessments.
Ability to address and resolve Audit Findings efficiently.
Experience conducting Fit for Purpose assessments.
Top Skills
IT systems process assessment experience
GxP
IT systems process assessment experience
GxP
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