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Senior Regulatory Compliance Lead
1 month ago
Job Title- Senior Regulatory Compliance Lead
Location- Hybrid in Cambridge, MA *(Travel is required)
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:
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.
