Senior Analyst, Compliance

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R&D Operations

Laboratory Operations

Professional

Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at

We are searching for the best talent for a Senior Analyst, Compliance in Malvern, PA or Spring House, PA.

The role of Sr. Compliance Analyst will support compliance activities across R&D Therapeutic Development & Supply (TDS) organization. A Compliance Associate is responsible for ensuring that a company adheres to all relevant regulations and quality standards within the industry. The position will support implementation of quality systems, ensuring local processes align with global regulations, ensuring 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.

This position will interact with TDS functional SMEs, process owners, and collaborate with quality organizations to promote compliance and proactively identify areas of improvements to reduce non-conformances and optimize processes. This role typically involves a variety of tasks aimed at maintaining compliance with laws and guidelines. Below is a detailed job description.

• Monitor and interpret relevant regulations and guidelines (e.g., FDA, ISO, OSHA, ICH, EMA, WHO, Compendial, etc.) applicable to the organization and in accordance with CMC stage gates and phases.
• Ensure compliance with regulatory requirements during research & development and tech transfer processes.
• Ensure that all processes are assessed per phased appropriate risks and meet quality & regulatory requirements.
• 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.
• Initiate Change controls, assess appropriate risks, execute plans per defined plan and timeline.
• Collaborate with cross-functional teams, including key partners and quality, to ensure E2E compliance.

• Ensure processes and laboratories are inspection ready at all times.
• Conduct informal audits and inspections of laboratory practices, documentation, and processes.
• Perform risk assessments and reviews to ensure adherence to quality standards throughout the project lifecycle.
• Identify gaps proactively and areas for improvement and implement corrective and preventive actions.
• Serve as a liaison between the functions, stakeholders, and quality during inspections and audits.

• Evaluate systems, applications, and processes to ensure safeguards are in place to maintain security and integrity of data including adequate electronic governance and audit trail are established for data controls and traceability through the life of the data.
• Ensures analytical software data flow is evaluated for per ALCOA++

• Prepare and review compliance documents, including protocols, Standard Operating Procedures (SOPs), and technical reports.
• Ensure that all documentation is accurate, complete, and in compliance with regulatory standards.
• Maintain control documentation related to compliance and quality processes.
• Prepare reports and presentations for stakeholders summarizing compliance status, findings from audits, and any necessary corrective actions.
• Prepare training materials and provide training on compliance and quality regulations.

• Conduct risk assessments to identify potential…