| Need Senior Regulatory Compliance Lead at Hybrid in Cambridge, MA-12 Months Contract at Cambridge, New York, USA |
| Email: [email protected] |
| From: Venki, NAM INFO INC [email protected] Reply to: [email protected] Hi Greetings from NAM Info Inc!!! Please find the below immediate requirements from my Client. Please revert me back with updated copy of resume, Visa status and contact details Note: Send resumes to [email protected] for quick submittals. Position: Senior Regulatory Compliance Lead Location: Hybrid in Cambridge, MA Duration: 12 Months Contract Job Summary: 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 regulatory standards. Excellent understanding of Pharma GXP assessment framework, FDA predicate rules, SLC Harmonization, 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. Top Skills: IT systems process assessment experience GxP Desired Skills: Excellent oral and written communication skills. Strong leadership and project management capabilities. Ability to work independently and manage multiple projects simultaneously. A proactive approach to staying updated with the latest industry regulations and standards. Thanks & Regards... Venki R 7327775185 -121 (EXT) Senior Executive (Staffing) N am Info Inc Email : [email protected] Website - www.nam-it.com 2525 US Highway 130, Building D, Suite 2-Cranbury, NJ-08512 The harder you work, the luckier you get Follow us on: USA | CANADA | INDIA MBE Certified Company , E Verify Company Note: This is not an unsolicited mail. Under Bill 1618 Title III passed by the 105th USA Congress this email cannot be considered as spam as long as we include our contact information and an option to be removed from our emailing list. If you have received this message in error or, are not interested in receiving our emails, please accept our apologies. To be removed from our mailing list, please reply with the subject line "REMOVE". All removal requests will be honored ASAP. We sincerely apologize for any inconvenience caused to you Keywords: access management rlang information technology Massachusetts New Jersey Need Senior Regulatory Compliance Lead at Hybrid in Cambridge, MA-12 Months Contract [email protected] |
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| Fri Aug 02 23:07:00 UTC 2024 |