Operations Compliance Specialist

Johnson & Johnson is recruiting for an Operations Compliance Specialist, located in Malvern, PA.

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 https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

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The Operations Compliance Specialist position in Malvern is an exceptional opportunity to join a world-class company and make a significant impact in the production of Biologics Drug Substance (DS) clinical supplies. As an Operations Compliance Specialist, you will play a crucial role in ensuring regulatory compliance and maintaining the highest quality standards. This is a unique chance to work with a proven team and contribute to the successful implementation of compliance systems.

The Malvern Clinical Operations & External Partnerships (MCO & EP) department is responsible for the production of Biologics Drug Substance (DS) clinical supplies at 3rd party contract manufacturing organizations (CMO’s), Drug Product/Drug Substance (DPDS) internal sites and Supply Chain internal sites. The MCO team is responsible for manufacturing the Biologics DS (drug substance) clinical supplies at the Malvern manufacturing site. The Operations Compliance Specialist position in Malvern is responsible to ensure the MCO team adheres to regulatory requirements and produces high quality batches. They will act as a key subject matter expert (SME) in Audit and Compliance topics to support the manufacturing and delivery of DS (drug substance) clinical materials per CMC (Chemistry Manufacturing & Control) timelines.

Key Responsibilities:

• Collaborate with internal teams at the site and global level to monitor and enforce standards and guidelines.
• Evaluate and assess any regulatory or compliance guideline updates to ensure the clinical manufacturing plant adheres to the latest standards.
• Monitor and track non-conformances, corrective actions, and change controls within the team to ensure on-time closure and drive completion of any resulting action items.
• Act as the department SME of compliance systems (i.e. Comet, Summit, Trackwise, Beacon).
• Act as the single point of contact (SPOC) for any new regulatory introduction that may come through the company.
• Act as the SPOC regarding quality and any new site-wide/global-wide initiatives or system rollouts.
• Act as the bridge/liaison between operations and quality organizations.
• Training coordination for the MCO department, including curriculum management and ownership, user group assignments, training leadership, and training compliance.
• Ensure operations readiness for internal and external audits and function as the primary contact for audits and inspections for the department.
• Ensure the high-quality standards of documentation are delivered and coordinate the internal periodic review of documentation within the department.
• Develop relationships with external contractor agencies.
• Periodically review the job descriptions of the contract workers to ensure they are meeting the needs of the department and work with the contracting agency to ensure delivery of the contractual obligations.
• Ensure that any issues or concerns are promptly communicated to the contracting agency and appropriate steps are taken to address the performance of contract workers.