Cognizant Technology Solutions is looking for a Compliance Test Manager with GXP to join our team of IT professionals in a permanent role. If you meet our background requirements and skills and are looking for an opportunity with these skills and expertise, here is the ideal opportunity for you!
About Cognizant's QEA Practice:
We are the largest Quality Assurance Practice Globally servicing 800+ Clients. We bring the industry-leading vision and expertise to help with Quality Engineering transformation journeys for our reputed clients.
Location: New York, NY
Required Skills
- Regulatory Knowledge: Deep understanding of industry-specific regulations and standards.
- Analytical Skills: Ability to interpret complex regulatory requirements and assess their impact on the organization.
- Attention to Detail: Meticulous attention to detail to ensure compliance with all regulatory requirements.
- Communication Skills: Strong ability to communicate regulatory requirements and policies effectively to all levels of the organization.
- Problem-Solving Skills: Ability to identify compliance issues and develop effective solutions.
- Project Management: Strong organizational skills to manage multiple compliance projects and deadlines.
- Risk Management: Proficiency in identifying and mitigating compliance risks.
- Audit Experience: Experience in conducting regulatory compliance audits and assessments.
- Leadership: Ability to lead and mentor a compliance team.
Roles and Responsibilities
- GxP Training, Inspection and Audit Readiness Manager.
- Manages, creates, and maintains training curricula and activities for stakeholders (around 1000 users).
- Authors and executes workflows for Standard Operating Procedures (SOP), Work Instructions (WI), Standards and Policy in Veeva Document Management System (VEEDMS).
- Authored and owned deviations, CAPA's, and Request for Change Controls (RFC), and Change Controls on regulatory, governance, clinical, and safety domains in Veeva Quality Management Suite (VEEQMS).
- Handles and monitors reports for training compliance, audit and inspection reports, SOX-related activities in Power BI Dashboards.
- Analysis and evaluating the Key Performance Indicators (KPI) for process improvement and CAPA's.
- Engaging and communicating highly technical information to different types of audiences, including senior business leaders, leadership, and project team members.
- Developing Compliance Programs: Creating and implementing compliance programs to ensure adherence to regulations.
- Monitoring Regulatory Changes: Keeping up to date with changes in regulations and ensuring the organization adapts accordingly.
- Conducting Audits: Performing regular audits to ensure compliance with regulatory requirements.
- Training and Education: Providing training to employees on compliance-related topics.
- Reporting: Preparing reports for senior management and regulatory bodies.
- Collaboration: Working with other departments to ensure comprehensive compliance coverage.
Salary and Other Compensation:
The annual salary for this position is between [$71,100- $112,500] depending on experience and other qualifications of the successful candidate. This position is also eligible for Cognizant's discretionary annual incentive program, based on performance and subject to the terms of Cognizant's applicable plans.
Work Authorization
Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship (H-1B, L-1B, L-1A, etc.)
Benefits:
Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
- Medical/Dental/Vision/Life Insurance
- Paid holidays plus Paid Time Off
- 401(k) plan and contributions
- Long-term/Short-term Disability
- Paid Parental Leave
- Employee Stock Purchase Plan
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