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.
Implement quality systems, ensuring local processes align with global regulations.
Investigate non-conformances thoroughly and implement corrective and preventive action plans in compliance with applicable regulations.
Collaborate with TDS functional SMEs, process owners, and quality organizations.

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 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.

Senior Analyst, Compliance

Key skills