WayUp
Johnson & Johnson, Operations Support Manager, Investigations - Application via
WayUp, Gurabo, Gurabo, us, 00778
Johnson & Johnson, Operations Support Manager, Investigations
WayUp is partnering with Johnson & Johnson to hire top talent. 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.
Location: Gurabo, Puerto Rico, United States of America.
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: Minimum bachelor’s in Science (e.g., Chemistry, Biology, Microbiology, Pharmacy), Engineering, or related field is required; master’s or higher degree is desirable.
Experience: At least six (6) years of experience in related areas within the pharmaceutical or biotechnology industry; working experience with investigations and/or complaints.
Skills: Root Cause Analysis and Technical Writing skills; people leadership experience.
Languages: Proficiency in Spanish and English (read, speak, write).
Preferred Qualifications
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% 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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Location: Gurabo, Puerto Rico, United States of America.
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: Minimum bachelor’s in Science (e.g., Chemistry, Biology, Microbiology, Pharmacy), Engineering, or related field is required; master’s or higher degree is desirable.
Experience: At least six (6) years of experience in related areas within the pharmaceutical or biotechnology industry; working experience with investigations and/or complaints.
Skills: Root Cause Analysis and Technical Writing skills; people leadership experience.
Languages: Proficiency in Spanish and English (read, speak, write).
Preferred Qualifications
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% 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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