Remote - Senior Regulatory Compliance Lead
Intone Networks Cambridge
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.
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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