Senior Analyst, Compliance

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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 securit