Operations Support Manager, Investigations bei Jj

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

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Pharmaceutical Process Operations

Job Category:

People Leader

All Job Posting Locations:

Gurabo, Puerto Rico, 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 an Operations Support Manager, Investigations to be in Gurabo, PR!

You will be responsible for successfully leading and operating the Janssen Investigation Unit, guided by the Operations Director. This role entails coordinating and leading the Gurabo Site Investigations Unit to ensure its contribution in recommending, proposing, and formalizing alternatives for process, utility, and system improvements. In addition, the manager is tasked with implementing operational procedures that align with cGMP (current Good Manufacturing Practices), regulatory requirements for investigations, as well as the company’s policies, standards, and procedures. This position also involves assigning and leading supervision resources within the unit, while providing support, mentorship, coaching, and continuous monitoring/feedback to ensure thorough and timely completion of the site investigations.

Key Responsibilities:

• Implement a science-based, quality-focused Investigations System compliant with cGMPs and Regulatory guidance, ensuring final reports are accurate, properly issued, and timely.

• Provide leadership to build an Investigations Unit that meets J&J Innovative Medicine and regulatory requirements for event investigations.

• Review and approve investigation reports; monitor progress to ensure timely completion in line with cGMPs, GDP, SOPs, and policies.

• Ensure thorough investigations of all events; final reports are accurate, properly issued, and timely.

• Optimize resource allocation for the Investigations Unit; anticipate needs for additional support to complete reports.

• Identify, report, and assess deviations or events compromising quality; recommend remediation or preventive actions.

• Monitor and trend root causes; assess effectiveness of corrective actions and drive Quality System improvements.

• Develop and maintain updated SOPs/procedures governing the Investigation Unit for consistent cGMP compliance.

• Stay current with GMP/regulatory changes; align investigations to the operating environment and provide ongoing training.

• Establish robust follow-up mechanisms and cross-functional communication to review monitoring results, ensure accountability, and prevent recurrence.

Qualifications

Education:

• A minimum of bachelor’s in Science (e.g., Chemistry, Biology, Microbiology, Pharmacy), Engineering, or a related field is required

• A master’s or higher degree is desirable

Experience and Skills:

Required: 

• At least six (6) years of experience in related areas within the pharmaceutical or biotechnology industry

• Working experience with investigations and/or complaints

• Root Cause Analysis and Technical Writing skills

• People leadership experience

• Proficiency in Spanish and English languages (read, speak, and write)

Preferred:

• Working experience in solids and/or parenteral manufacturing

• Inspection and audit readiness experience

• Proficiency in SAP system  

Other:

• This position may require up to 10% of domestic/international travel

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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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