| Sr Regulatory Compliance Lead // 6+ Months // Hybrid in Cambridge, MA *(Travel is required) at Cambridge, New York, USA |
| Email: [email protected] |
| Hi Team, Client: CTS / Vertex Location: Hybrid in Cambridge, MA *(Travel is required) Duration: 6+ Months LinkedIn and Passport Number Mandatory 15+ Years of Experience Skills: Strong analytical, problem-solving, and project management skills. Excellent communication and interpersonal skills. Identify project Risk & Issues and assist in providing the required mitigation plan. Domain knowledge: Leverage the Life Sciences domain knowledge in implementation of process, tools and technology, focused best practices to oversee and ensure that the appropriate controls and validation requirements are implemented. Support/ Lead creation of SOPs, business process documents and work instructions. Certifications: Relevant certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar are a plus. Preferred Skills/Qualification: Leadership: Ability to lead and motivate cross-functional teams. Attention to Detail: Strong attention to detail and commitment to quality. Adaptability: Ability to adapt to changing regulatory environments and industry trends. Strategic Thinking: Ability to think strategically and develop long-term plans for compliance and process improvement. Education: Bachelor's degree in Life Sciences, Engineering, or a related field. Advanced degree (Master's or Ph.D.) preferred. Experience: Minimum of 15-20 years of experience in the life sciences industry, with a focus on Process assessments, Risk management, and process improvement. Support and lead change management activities for systems. Knowledge: In-depth knowledge of GxP guidelines (GMP, GLP, GCP, GDP, GVP) and regulatory requirements (21 CFR Part 11, EU Annex 11). Job Description- Enterprise-Level Assessment: Lead the assessment of GxP systems across the enterprise to ensure compliance with regulatory requirements and industry best practices. Risk Management: Develop and implement risk management strategies to identify, assess, and mitigate risks associated with GxP systems and processes. Process Improvement: Evaluate and improve existing processes to enhance efficiency, compliance, and quality. Regulatory Compliance: Ensure that all GxP systems and processes comply with relevant regulatory standards, including FDA, EMA, and other global regulatory bodies. Study the impact on tools (ALM, Vaults & Service Now) & Framework Documentation and Reporting: Maintain comprehensive documentation of assessments, risk management activities, and process improvements. Prepare and present reports to senior management and Client business stakeholders Stakeholder Collaboration: Work closely with cross-functional teams, including Quality Assurance, IT, Operations, to ensure alignment and compliance. Training and Development: Provide training and guidance to staff on GxP compliance, risk management, and process improvement. Continuous Improvement: Plan continuous improvement by enabling periodic review of the process adherence "I may miss your call , but I never miss to reply to you . Email is the best way to reach me" Thanks , Gopi | 469.639.2505 www.OrbITpeople.com Keywords: information technology Massachusetts Sr Regulatory Compliance Lead // 6+ Months // Hybrid in Cambridge, MA *(Travel is required) [email protected] |
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| Thu Jul 25 19:58:00 UTC 2024 |