We are looking for a Compliance Manager to join our team in India. This is an amazing opportunity to work on the Quality and Compliance aspects of all of Clarivate’s GxP offerings in the Life Sciences business lines.
About You – experience, education, skills, and accomplishments
- Graduate or Postgraduate preferably in life sciences. Equivalent experience may be accepted in lieu of a degree.
- At Least 7 years of experience in a software/Computer Systems Validation (CSV) role within the pharmaceutical or life sciences industries, experience in creating and maintaining SOPs preferred
- Must be familiar with US and EU regulations and guidance
It would be great if you also had . . .
- Experience in creating and maintaining SOPs preferred
- Proven ability to work with and direct diverse and cross-functional teams to accomplish goals
- The ability to interact confidently with department heads and other senior leadership regarding corporate compliance
What Will You be Doing in this Role?
Assists with Governing GxP Computer Systems Validation by:
- Working directly with members of Regulatory Compliance Management and other internal teams to ensure the accuracy and consistency of system software development validation deliverables, as well as to proactively communicate the status of validation undertakings, including communication of any identified barriers to management.
- Assisting with authorship and conduct of other assigned pre-and/or post-review/approval activities related to computer systems Validation documentation. This includes but is not limited to, System Risk Assessments, 21 CFR Part 11 Assessments, Computer Validation Plans, Test Plans, Test Reports, Requirement Specifications, Release Memos and Validation Summary Reports.
- Supporting and/or conducting Validation efforts for all internal projects, as assigned.
- Fostering Validation knowledge both for development teams as well as the wider Clarivate audience.
- Reporting results and reviewing anomalies, as appropriate, to the Regulatory Compliance team.
- Ensuring a high degree of Inspection Readiness for Systems in CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within CSV responsibility
- Utilizes expert knowledge in identification and management of risks pertinent to computer systems validation practices within a regulated landscape.
- Proactively monitor systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
Facilitates the identification and development of Standard Operating Procedures (“SOP”) by:
- Assisting with the writing, revising, and reviewing of Validation SOPs, as assigned
Assists with the management of other Quality/Regulatory Compliance initiatives and programs by:
- Supporting Regulatory Compliance team management with the development, monitoring, and management of in-scope project costs, schedules, resources, and quality/compliance standards.
- Assisting with developing and enhancing quality/compliance processes to promote, facilitate, and ensure compliance with all regulatory and company standards.
- Participating in the development and maintenance of quality systems and process improvements
- Investigating quality/compliance issues and identifying/implementing corrective and/or preventative actions, as directed
- Supporting the development and implementation of proper document management and change control processes relating to system development and Validation.
- Supporting internal and external audit activities (including, but not necessarily limited to customer and Health Authority regulatory audits).
About the team
The Quality & Business Excellence team oversees the entire Quality Management System (QMS) of our directly or indirectly GxP-regulated software offerings. We work closely with all other functions of the business, including (but not limited to) Technology/Development, IT/Infrastructure, Risk Management office, Information Security, Operations, Finance, and Legal. The team currently consists of 7 deeply experienced Quality Management professionals, across geographies in the U.S., U.K., and India.
Hours of Work
- You will be expected to work on a work schedule (12: 00 PM IST to 9:00 PM IST) to provide for reasonable hours of collaborative work with the US team and there could be a slight extension on an as-needed basis.
- Hybrid Work mode
At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.
