Remote - Senior Regulatory Compliance Lead

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Job description

Job Title- Senior Regulatory Compliance LeadLocation- Hybrid in Cambridge, MA (Travel is required)Duration;Start Date: 8/12/2024End Date: 1/31/2025Years of Experience:15+ Years of Experience 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 Required Skills/Qualifications: 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). 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.

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