Senior Regulatory Compliance Lead
Posted on :
24-07-2024
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Job Description
Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. Our client is an American multinational information technology services and consulting company and is a leading provider of information technology consulting and business process outsourcing services dedicated helping the worlds leading companies build stronger businesses.
Title: Senior Regulatory Compliance Lead
Work Location: Cambridge MA 02139
Job Type: Contract
Work Type: Hybrid (Travel is required)
Duration: 5 Months
Job Description:
- EnterpriseLevel 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 crossfunctional 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:
- Bachelors degree in Life Sciences Engineering or a related field. Advanced degree (Masters or Ph.D.) preferred.
Experience:
- Minimum of 1520 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:
- Indepth knowledge of GxP guidelines (GMP GLP GCP GDP GVP) and regulatory requirements (21 CFR Part 11 EU Annex 11).
Skills:
- Strong analytical problemsolving 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 crossfunctional 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 longterm plans for compliance and process improvement.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Employment Type
Full Time
Key Skills
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