Senior Analyst, Compliance

Johnson & Johnson Innovative Medicine•Malvern, PA

1d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

A master’s degree or relevant certifications is a plus.
Strong project management skills leading & driving compliance improvement activities are preferred.

Responsibilities

Regulatory & Quality Compliance 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.
Audits & Inspections 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.
Laboratory Applications and System Support 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++ Documentation and Reporting 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.
Risk Management Conduct risk assessments to identify potential compliance risks and develop strategies for mitigation.
Monitor compliance issues/trends and strategize & implement improvements ensuring ongoing compliance.
Continuous Learning/Training Stay updated on changes in regulations and industry standards to ensure the organization’s compliance framework aligns with current requirements.
Participate in continuous improvement initiatives to enhance quality and compliance processes.
Provide training to organizational leaders, peers, and stakeholders on compliance requirements, quality standards, and best practices.
Serve as a resource for other scientists and team members regarding compliance-related issues.