Sr Supervisor Ops Investigations

Johnson & Johnson • Gurabo, PR

3d • Hybrid

About The Position

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.

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 Sr Supervisor Ops Investigations to join our Team! This is an onsite/hybrid role.

Requirements

• A Bachelor’s degree in Science, Chemistry, Biology, Microbiology, Pharmacy, Engineering, or a related field is required.
• A minimum of five (5) years of experience in related areas within the pharmaceutical, biotechnology, or related industry is required.
• Minimum two (2) years of supervisory experience in related areas within the pharmaceutical, biotechnology, or related industry is required.

Nice To Haves

• A master’s degree is desirable but not mandatory.
• Working experience in solid dosage forms and/or parenteral manufacturing is highly desirable.

Responsibilities

• Responsible for directly supervising the Operations Support Specialists - Investigations and Sr. Operations Support Specialists - Investigations, coordinating activities related to the investigation of events in Janssen Gurabo.
• Ensure that all events are thoroughly investigated in accordance with cGMPs, FDA, and other regulatory guidelines in the pharmaceutical industry, and that final reports are accurate, properly issued, and completed in a timely manner.
• Provide leadership and guidance to direct reports to meet the requirements of both J&J Innovative Medicine and Regulatory Agencies in relation to event investigation.
• Review investigation reports and monitor progress to ensure timely completion, consistent with cGMPs, Good Documentation Practices, site SOPs, policies, and operational needs.
• Write investigation reports as necessary.
• Monitor investigation unit activities to ensure resources are appropriately assigned and anticipate the need for additional assistance in completing reports.
• Monitor, analyze, and evaluate root causes identified in investigations to review the effectiveness of previously implemented actions and recommend improvements to Quality Systems if necessary.
• Develop and maintain updated procedures outlining the operation of the Investigation Unit to consistently meet applicable cGMPs.
• Maintains current with new or revised GMP regulations, site products, controls, projects, and processes to ensure investigation reports align with the operating environment.
• Ensure that Investigation Unit resources receive adequate and consistent training in applicable procedures and stay up to date on procedure revisions, as well as technical and regulatory knowledge required for their responsibilities.
• Identify and promptly notify management of deviations or events where the quality standards of a product/material may compromise marketed products and recommend action plans for remediation or prevention.
• Collaborate and communicate effectively with relevant functional areas to discuss due date commitments that may impact material/product release and explore alternative actions, if necessary.
• Maintain open communication with Janssen colleagues and external customers/contractors when evaluating events or actions involving the processing or testing of Fajardo products at other sites and inform management of the need for extended investigation or actions.
• Provide technical assistance to Investigation Unit resources and site functional area management and participate in the review and evaluation of GMP-related issues related to manufacturing, packaging, storage, and laboratory processes (e.g., investigations, CAPAs, APRs, changes, audits).
• Participate, lead, or assist in Cross Functional Investigations and RCPS, as required.
• Establish an effective follow-up mechanism or system to ensure investigation activities are consistently addressed, reports are issued, and timely completion is achieved.
• Regularly communicate with functional areas to review and share the results of monitoring and trending evaluations, providing feedback on the effectiveness of actions taken and requiring commitments or accountability to prevent recurrence.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager