At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

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Job Function:

R&D Operations

Job Sub Function:

Laboratory Operations

Job Category:

Professional

All Job Posting Locations:

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

Job Description:

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 https://www.jnj.com/innovative-medicine

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

Job Description

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.

Core 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.

Qualifications

• Education: Bachelor’s degree in a relevant scientific discipline, life sciences, engineering, or a related field. A master’s degree or relevant certifications is a plus.
• Experience: 5+ years of experience in GMP laboratories, with a focus on compliance within a regulated environment.

Skills

• 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.

Work Environment

• The Compliance Associate typically works in an office environment but may require visits to laboratories and clinical & commercial manufacturing facilities.
• This role requires occasional travel to expanded Malvern facility (outside of the main campus) and to nearby sites in PA & NJ up to 25% in the US and up to 10% outside US.
• This role is integral to the organization’s success by ensuring that all products and processes not only comply with regulations but also meet the highest quality standards.

This job posting is anticipated to close on March 9, 2026. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state, or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid 

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Coaching, Communication, Data Management and Informatics, Epidemiology, Ethical and Participant Safety Considerations, Inventory Management, Laboratory Operations, Laboratory Safety, Mental Agility, Molecular Diagnostics, Motivating People, Problem Solving, Research and Development, Standard Operating Procedure (SOP), Toxicology, Vendor Management