Support compliance activities across R&D Therapeutic Development & Supply (TDS) organization.
Ensure that a company adheres to all relevant regulations and quality standards within the industry.
Support implementation of quality systems, ensuring local processes align with global regulations.
Ensure non-conformances are investigated thoroughly, approved in a timely manner, and appropriate corrective and preventive action plans are implemented in compliance with applicable regulations and guidance.
Interact with TDS functional SMEs, process owners, and collaborate with quality organizations to promote compliance.
Monitor and interpret relevant regulations and guidelines applicable to the organization.
Ensure compliance with regulatory requirements during research & development and tech transfer processes.
Implement and maintain quality management systems (QMS) to ensure compliance with applicable standards.
Initiate nonconformance investigations and independently drive related activities including identification of root cause, defining, and executing corrective action plans, preventive measures, monitor effectiveness measures.
Collaborate with cross-functional teams, including key partners and quality, to ensure E2E compliance.

Bachelor’s degree in a relevant scientific discipline, life sciences, engineering, or a related field.
5+ years of experience in GMP laboratories, with a focus on compliance within a regulated environment.
Knowledge of current U.S. and EU cGMP’s/regulatory standards is required.
Knowledge of 21 CFR/Part 11 Compliance regulations governing equipment and application validation and controls is required.
Experience with GMP laboratory processes including working within lab testing environment is preferred.
Experience with conducting E2E investigations and defining corrective action plans is required.
Experience with performing change controls, assessing risks, executing plans in accordance with approved plan is required.
Focus on achievement and delivery of results with high sense of urgency is required.
Excellent analytical and problem-solving skills are required.
Attention to detail and organizational skills are essential for managing compliance documentation is required.
Excellent written and verbal communication skills are required.
Proficiency in relevant software and databases is preferred.
Ability to work independently and in team environment within matrix organization is required.
Strong project management skills leading & driving compliance improvement activities are preferred.

Senior Analyst, Compliance

Key skills