Manager Preclinical Quality Risk Management- GLP Lead
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Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Manager Preclinical Quality Risk Management- GLP Lead, located in Spring House, PA, USA or Beerse, Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssen.com for more information.
This position will enable end to end quality risk management for Janssen R&D business partners performing or outsourcing Good Laboratory Practice (GLP) work. The Manager Preclinical Quality Risk Management will partner with business functions to manage quality risks and coordinate issue resolution in order to promote submission success and protect approval status. The role includes proactive risk identification, assessment and mitigation at the level of external service providers, internal GLP-related processes or programs as well as new asset integration in close collaboration with partner functions. Key business partners include Nonclinical Safety, Discovery Sciences, Janssen Biotherapeutics, Preservation and Material Protection, Viral Vaccines, Environmental Health, Safety & Sustainability.
• Manage execution of the GLP Internal and Contract Research Organization (CRO) partners integrated quality risk management framework in collaboration with key Janssen and CRO stakeholders.
• Maintenance of GLP universe (internal and CRO) across Janssen R&D.
• Identification of systemic risks related to GLP quality management systems (internal and CRO) and/or Janssen’s oversight processes with input from different angles including Health Authority information, performance monitoring, audit findings, business partner strategies and insights, evolving regulatory requirements and trends etc.
• Collaborate with cross-functional preclinical development teams to assess identified risks and develop risk mitigation activities.
• Ensure appropriate risk monitoring, oversight and communication.
• Capture key risks and mitigation plans in a risk management system and assure all actions are driven to resolution
• Support development of the audit schedule and scoping of GLP audits as requested from BRQC QA
• Lead quality components related to qualification of new GLP CROs in support of the overall sourcing strategy
• Contextualize key quality insights to primary stakeholders and provide quality consultancy
• Support timely management of significant quality events related to internal and CRO contractual services in collaboration with relevant preclinical functional teams including but not limited to formal escalation, support of CAPA development and/or overseeing execution of risk management activities
• Provide quality input into governance models led by key GLP stakeholders to assure operational management is assessed for potential quality impact. Facilitate risk mitigation activities as needed to address quality concerns that arise from operational governance models
• Support health authority inspections and post-inspection commitments to address requests/commitments related to GLP
• Support CRO components of integration plans following a license or acquisition deal
• Support GCLP, Animal Welfare, preclinical non-GLP or Discovery risk management activities as assigned by the Preclinical Risk Management Head
• BA/BS required, MA/MBA preferred
• Minimum 8 years of expertise in pharmaceutical/biotech environment is required.
• Minimum 5 years of expertise in GLP required.
• Active experience as study director, principal investigator and/or quality professional required.
• In depth knowledge of global OECD and FDA GLP regulations and guidelines required.
• Familiar with different GLP study types and components such as toxicology, pathology, bioanalysis, genetic toxicology, toxicokinetics in a global multisite setting required.
• Collaborative and open attitude, customer oriented, diplomatic and problem-solving skills, familiar with risk-based thinking.
• Risk management experience is preferred.
• Must be proficient in English language
• Awareness of quality requirements in Discovery and non-GLP development, GCLP and of Animal Welfare is preferred.
• May require less than 10% travel
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)