Quality Assurance Senior Supervisor

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 Med Tech, 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.

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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:
Quality

Job Sub Function:
Quality Assurance

Job Category:
People Leader

All Job Posting Locations:
Athens, Georgia, 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

We are searching for the best talent for
Quality Assurance Senior Supervisor to be located in Athens, GA
.

Purpose

The Quality Assurance Senior Supervisor is responsible for the effective supervision and operation of the site Quality Investigation Unit, under the guidance of the Site Quality Head. Implement operational procedures to ensure that the Quality Investigations Unit functions are aligned with the cGMPs and FDA guidance. Supervises and coordinates the unit's resources activities providing support, guidance, advice and continuous monitoring/feedback to the Senior Investigation Quality Leaders to ensure that final investigation reports are thorough and completed on a timely basis.

Key Responsibilities

• Responsible for supervision of the Senior Investigation Quality Leaders and coordinates the overall activities related to the investigation of events in Innovative Medicine Athens, GA site.
• Ensure that all events are thoroughly investigated as per cGMPs and FDA and other Regulatory pharmaceutical industry guidance and that the final reports are accurate, adequately issued and timely completed.
• Provides leadership and direction to dotted/direct reports to satisfy both the Johnson & Johnson Innovative Medicine and the Regulatory Agency's requirements in relation to the investigation of events.
• Reviews investigation reports and monitors its progress to ensure these are completed in a timely manner, consistent with the cGMP's, Good Documentation Practices, site SOP's and policies and site operations' needs.
• Monitors the investigation unit activities to ensure resources have been adequately assigned and anticipate the need to provide or request additional assistance in accomplishing the completion of reports.
• Monitors, trends and evaluates the root causes identified in investigations in order to review the effectiveness of previously implemented actions or if additional actions are deemed necessary, such as recommending improvements to Quality Systems in light of gaps identified during the root cause analysis.
• Develops and maintains updated procedures that outline the operation of the Quality Investigation Unit to consistently and effectively meet the applicable cGMP.
• Ensures that the Investigations Unit resources are adequately and consistently trained in the procedures applicable to the position and up to date in the corresponding procedure revisions to effectively perform the duties assigned.
• Identifies and promptly notifies management of deviations or events where the quality standards of a product/material compromise marketed products and recommends action plans to remediate or to prevent such events.
• Liaise and effectively interacts with applicable functional areas to assure due date commitments that may affect material/product release are discussed or alternative actions can be implemented.
• Maintains an open communication process with other colleagues and external customers/contractors as required assisting in the evaluation of events or actions that involve the processing or testing of the products at other sites and informing management of the need to extend the investigation of the event and/or such actions.
• Provides technical assistance to the Investigation Unit resources and site functional area management and participates in the review and evaluation of GMP related issues that involve manufacturing, packaging, storage and laboratory processes, e.g., from investigations, CAPAs, APRs, changes or audits.
• Participates, leads and/or assists Cross Functional Investigations and RCPS, as required.
• Establishes an effective follow up mechanism or system to monitor that…