QEA Compliance Lead

2 days ago

Boston, United States Cognizant Full time

Cognizant Technology Solutions is currently seeking a highly skilled QEA Compliance Lead - Life Science who will be responsible for overseeing the enterprise-level assessment of GxP (Good Practice) systems, conducting risk assessments, and evaluating processes to ensure compliance with regulatory standards. This role requires a deep understanding of GxP guidelines, risk management, and process improvement.

Are you ready to be a change-maker? At Cognizant, we believe those who challenge the way they work today will lead the way tomorrow Ability to work independently and remotely, with willingness travel for client engagements as needed.

Responsibilities:

· Lead the assessment of GxP systems across the enterprise to ensure compliance with regulatory requirements and industry best practices.

· Develop and implement risk management strategies to identify, assess, and mitigate risks associated with GxP systems and processes.

· Evaluate and improve existing processes to enhance efficiency, compliance, and quality.

· 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

· Maintain comprehensive documentation of assessments, risk management activities, and process improvements. Prepare and present reports to senior management and Client business stakeholders

· Work closely with cross-functional teams, including Quality Assurance, IT, Operations, to ensure alignment and compliance.

· Provide training and guidance to staff on GxP compliance, risk management, and process improvement.

· Plan continuous improvement by enabling periodic review of the process adherence

Required Skills/Qualifications:

· 18+ years of experience in the Life Sciences industry specific to QEA – Quality Engineering and Assurance, with a focus on Process assessments, Risk management, and process improvement.

· Support and lead change management activities for systems

· In-depth knowledge of GxP guidelines (GMP, GLP, GCP, GDP, GVP) and regulatory requirements (21 CFR Part 11, EU Annex 11).

· 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.

· 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.

· Ability to lead and motivate cross-functional teams, adapt to changing regulatory environments and industry trends and attention to detail and commitment to quality.

· Think strategically and develop long-term plans for compliance and process improvement.

· Bachelor's degree in Life Sciences, Engineering, or a related field.

Preferred Skills/Qualification:

· Relevant certifications such as Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar are a plus.

· Advanced degree (Master's or Ph.D.) preferred.

Home office setup (network, phone, etc.) Our strength is built on our ability to work together. Our diverse backgrounds offer different perspectives and new ways of thinking. It encourages lively discussions, inspires thought leadership, and helps us build better solutions for our clients. We want someone who thrives in this setting and is inspired to craft meaningful solutions through true collaboration.

If you are comfortable with ambiguity, excited by change, and excel through autonomy, we’d love to hear from you.

#LI-FA1

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