Manager, Quality Clinical Risk Management

Job description

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. Job Function: Quality Job Sub Function: Clinical Quality Job Category: Professional All Job Posting Locations: Beerse, Antwerp, Belgium Job Description: Johnson & Johnson is currently seeking a Manager, Quality Clinical Risk Management to join our R&D Quality CRM team located at a J&J office in Spring House, PA; Titusville, NJ; Raritan, NJ; Horsham, PA: High Wycombe, UK: Beerse, Belgium; Basel, Switzerland, and Madrid, Spain. 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 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): US- Requisition Number: R-106260 UK - Requisition Number: R-106893 Belgium - Requisition Number: R-106896 Spain- Requisition Number: R-106903 Switzerland - Requisition Number: R-106912 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. This is a position in R&D Clinical Quality. This Manager role is an independent clinical quality-risk leadership position responsible for translating risk signals into proactive mitigation, escalation, inspection/submission readiness, and quality decision support across trials and programs. The role combines hands-on risk ownership with significant cross-functional influence With minimal direction from the RDQ Dir, Clinical Risk Management: •Risk Management: Actively participates all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies. • Leads regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned). • Maintains CQP (Clinical Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews • Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews • Communicates and facilitates risk updates to R&D Business Partners as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned). • Highlight new potential systemic risk to RDQ CRM management. Issue Consultation, Issue Escalation, and Compliance Assessment: Develops and ensures a consistent interpretation of issues that require quality investigations • Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management. • Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities • In collaboration with partners in RDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self - Identified, Inspection, Audit) Submission Support: Pre-submission Quality Portfolio Review (QPR) • Leads the Cross-Functional Trial Team and other key contributors in QPR content development & follow-up Activities • Coaches and mentors other team members on QPR for coordination and management of activities Inspection Readiness and Support • Drives ongoing inspection readiness activities with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including, preinspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams. • Provides front and back room support for Sponsor-Monitor inspections at J&J Sites including post inspection support. Provide inspection support per contractual agreement for third party inspections (vendors, co-development partners and contract research organizations) • Provides remote support for investigational site inspections including post inspection support. • Provides supervision and/or coaching for others on inspection support and readiness Consultancy • Provides independent advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy. Post-licensing and Acquisition (L&A) / Integration: With the guidance from the CRM L&A Team and Therapeutic Area Head or Delegate: • Support the coordination of the quality integration of the acquiring asset or company/partner and deliver robust documentation within the program/trial integration plans (90-day plan) and execute assigned responsibilities per plan. • Provide general guidance to stakeholders • As required, provide input into Quality Agreements with (Co-)development Partners and execute responsibilities per agreement. • Supports and facilitates asset divestment Other activities: Participates in CRM, cross-RDQ J&J, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions (as a team member or workstream/project lead). • Works with limited supervision, independently making decisions for compounds and studies • Provides training and coaching to peers and new employees, as needed Required Minimum Education: BA/BSc or equivalent (Scientific, medical, or related discipline) Required Years of Related Experience: A minimum of 8 years of experience working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) required Required Knowledge, Skills and Abilities: • Proficiency in Microsoft Office Applications • Proficiency in speaking and writing English • Excellent interpersonal, oral, and written communication skills • Proven strong GCP quality and/or clinical trials experience • Experience collaborating in a cross-functional team environment • Flexibility to respond to changing business needs • Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures Percentage Traveled: Up to 10% (Primarily domestic travel with some international travel) Preferred Related Industry Experience: Healthcare industry (pharmaceutical industry and/or healthcare/hospital system) Preferred Knowledge, Skills and Abilities: • Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP) • Experience wit