Sr. Specialist External Quality
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.
While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Belgium R-109826, Italy R-109827, Switzerland R-109772 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Latina, Italy
Job Description
External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners. In this role, you will play a crucial part in maintaining the highest quality and compliance standards for our Synthetic products, specifically focusing on Drug Products,
produced at external manufacturing sites. You’ll collaborate closely with our External Quality Site Lead and be a champion for quality in everything we do The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.
Key Responsibilities
Provide quality assurance support and oversight for external Synthetics manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities. Review, coordinate and provide quality concurrence or approval, as applicable, for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements. Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends. Identify, communicate and escalation quality, compliance or supply risks in a timely manner and support practical, risk-based mitigation and remediation plans. Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners in alignment with External Quality processes. Collaborate with External Quality Site Leads, Product Quality, MSAT,
Planning, Procurement, Regulatory, EHS, Qualified Persons and external partners to ensure registered requirements and patient supply needs are met. Support external manufacturers during J&J; audits, health authority inspections and regulatory commitments, including preparation, response review and follow-up of agreed actions. Participate in technology transfer, new product introduction, product lifecycle management, process improvement and risk management initiatives for Synthetic products. Contribute to continuous improvement of External Quality processes, documentation practices, quality culture and performance management across internal and external stakeholders.
Minimum Qualification
Minimum of a Bachelor’s degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline. Minimum of 4 years of experience in quality management, quality assurance, production, quality control, R&D; or a related pharmaceutical and/or biotechnology environment. Experience working in a GMP-regulated environment, preferably including quality support for external manufacturing, drug product or drug substance manufacturing, packaging, testing, release or commercial supply. Working knowledge of cGMP, ICH requirements, quality systems and applicable health authority expectations. Ability to review and assess quality records, identify gaps, support root cause analysis and contribute to effective CAPA and risk-based decision-making. Excellent verbal and written communication skills, including the ability to communicate effectively with internal functions and external partners. Ability to work independently with minimal supervision, manage multiple priorities, meet tight timelines and
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.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.
While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): Belgium R-109826, Italy R-109827, Switzerland R-109772 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Latina, Italy
Job Description
External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners. In this role, you will play a crucial part in maintaining the highest quality and compliance standards for our Synthetic products, specifically focusing on Drug Products,
produced at external manufacturing sites. You’ll collaborate closely with our External Quality Site Lead and be a champion for quality in everything we do The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.
Key Responsibilities
Provide quality assurance support and oversight for external Synthetics manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities. Review, coordinate and provide quality concurrence or approval, as applicable, for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements. Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends. Identify, communicate and escalation quality, compliance or supply risks in a timely manner and support practical, risk-based mitigation and remediation plans. Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners in alignment with External Quality processes. Collaborate with External Quality Site Leads, Product Quality, MSAT,
Planning, Procurement, Regulatory, EHS, Qualified Persons and external partners to ensure registered requirements and patient supply needs are met. Support external manufacturers during J&J; audits, health authority inspections and regulatory commitments, including preparation, response review and follow-up of agreed actions. Participate in technology transfer, new product introduction, product lifecycle management, process improvement and risk management initiatives for Synthetic products. Contribute to continuous improvement of External Quality processes, documentation practices, quality culture and performance management across internal and external stakeholders.
Minimum Qualification
Minimum of a Bachelor’s degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline. Minimum of 4 years of experience in quality management, quality assurance, production, quality control, R&D; or a related pharmaceutical and/or biotechnology environment. Experience working in a GMP-regulated environment, preferably including quality support for external manufacturing, drug product or drug substance manufacturing, packaging, testing, release or commercial supply. Working knowledge of cGMP, ICH requirements, quality systems and applicable health authority expectations. Ability to review and assess quality records, identify gaps, support root cause analysis and contribute to effective CAPA and risk-based decision-making. Excellent verbal and written communication skills, including the ability to communicate effectively with internal functions and external partners. Ability to work independently with minimal supervision, manage multiple priorities, meet tight timelines and