Manager, JJEI Quality Risk Management

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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Johnson & Johnson is currently seeking a Manager JJEI Quality Risk Management to join our team located in Raritan NJ Spring House PA New Brunswick NJ or Titusville NJ with considerations given to alternate US based J&J sites at the discretion of the business.

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 Manager Quality Risk Management (QRM) is responsible for ensuring continuous improvement and sustainability of the Johnson & Johnson Enterprise Innovation (JJEI) Quality Management System in accordance with applicable regulatory requirements current Good Clinical Practices Good Laboratory Practices Good Manufacturing processes Good Pharmacovigilance Practices Safety Vigilance and company policies and procedures. The Manager is responsible for assessing compliance risks and analyzing information in order to provide management with risk assessments based on current regulations and company standards. The Manager will ensure appropriate actions are taken regarding various issues systemic or otherwise. The Manager will also play a pivotal role in the Development teams by providing robust quality strategies to guide new initiatives from the development through the clinical phases of drug and device trials.

Responsibilities

Risk Management

• Actively participates in R&D activities contributing to the identification and assessment of key risks and advising team members on effective mitigation strategies.
• Highlight new potential systemic risks to management.
• Collaborates with business partners across departments franchises sectors and RDQ to advise collaborate and solve on areas for improvement.
• Actively works with cross-functional business partners to provide early quality strategy identify risks and enact mitigation plans accordingly.

JJEI Quality Management System

• Support the creation control and distribution of the JJEI Quality Manual.
• Participate in the JJEI Quality System Management Review process to manage the effectiveness of the QMS.
• Provide the processes tools and support to enable JJEI to identify and communicate product quality complaints adverse events and other issues.
• Facilitate the Escalation process for JJEI quality and regulatory issues and events.
• Assist in the development of a Quality Audit Program to monitor the effectiveness of the quality system monitor the quality system of applicable suppliers and manage external audits (including Health Authority / Regulatory Agency Inspections).
• Collaborate with appropriate RDQ teams and/or sector business partners to:
  • Provide Documentation Management processes tools and support to enable JJEI management of procedural documents
  • Provide the Qualification & Training processes tools and support to enable JJEI management of Job Descriptions Summaries of Experience Training Curricula and Training Records
  • Provide Purchasing Controls processes tools and support to enable the JJEI use of Qualified Suppliers
  • Facilitate the quality and compliance due diligence assessment of external opportunities
  • Facilitate the establishment of quality agreements including Intra-Company Quality Agreements (ICQA) between JJEI and other J&J entities
• Assess and recommend the processes tools and support to enable the management of JJEI Nonconformance Root Cause & Corrective Action and/or Preventative Action (CAPA).

Support R&D initiatives across Medical Devices Innovative Medicine and JJEI

• Serve as the RDQ representative on JJEI solution development / clinical study teams / design and development teams.
• Support the JJEI Quality Management System by contributing to procedural revisions development of ICQAs providing metrics and supporting where other RDQ functions cannot be leveraged.
• Participate in the ongoing development deployment and execution of fit-for-purpose approach for the JJEI organization to enable the development of an innovative portfolio for single and cross sector programs.
• Support new asset and company integration as needed. Coordinate with the sector and JJEI to identify RDQ GxP quality risks in the post-acquisition phases and present integrated risk management solutions to senior leadership teams.
• Function as an advisor concerning GCP GLP GMP and Good Documentation Practices (GDP) providing appropriate compliance guidance to personnel performing human use activities. Contributes to implementation of processes and systems that lead to collection of data relevant to reporting quality metrics and continuous improvement.
• Oversee quality system element responsible team(s) to ensure appropriate management and support of JJEI core QMS related activities that encompass both drug and device(e.g. Audit Management Inspection Management Escalation Qualification & Training Document Controls Purchasing Controls NC/CAPA).

Other Duties

• Participate in Med Tech and Pharma sector initiatives related to Device Quality Systems and other related duties as assigned by management.
• Develop and apply advanced knowledge related to Design Data Analysis Advanced Statistics etc.
• Remain current in skills and industry trends. Assures personal training and skill levels remain current by promptly completing assigned training and remaining current in professional and industry knowledge/trends.
• Maintain relevant and necessary GMP knowledge.
• Assist in the development and training of staff members.
• Attend project team meetings as needed and communicate outcomes to supervisor.
• Participate on technical or other internal teams as required.
• Carry out duties in compliance with all local state and federal and international regulations and guidelines including EMEA FDA EPA OSHA and global health authorities as applicable. Comply with all company and site policies and procedures.
• Successfully complete regulatory and job training requirements.

Requirements

• Required Minimum Education: BA/BSc or equivalent
• Required Years of Related Experience: A minimum of 8 years of experience working in the healthcare industry (pharmaceutical industry medical device industry contract research organization and/or healthcare/hospital system) required
• Proficiency in Microsoft Office Applications
• Proficiency in speaking and writing English
• Excellent interpersonal oral and written communication skills
• GCP quality and/or clinical trials experience in pharmaceutical or other regulated product development
• Experience with Quality Systems including ISO 13485 ISO 14971 EN 62366 cGMP and ICH requirements
• Knowledge of Combination Product Devices Biotech and/or Pharma Manufacturing particularly in technology transfer/design transfer design controls and risk management
• Strong Decision-Making Skills: Makes decisions independently on problems and methods
• Excellent technical writing skills; experienced in SOPs protocols reports
• Working knowledge of statistical methods/processes
• 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.
• Up to 10% travel expected (primarily domestic travel with some international travel)

Preferred Knowledge Skills and Abilities:

• Strong knowledge of Good Manufacturing Practice (GMP) Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP)
• Experience with fundamentals of clinical trial risk management
• Global clinical trial experience
• Experience working in a Quality function (Quality Management Quality Assurance/Control and / or Compliance)
• Experience working to ICH guidelines
• Health Authority Inspection experience (FDA EMA and other inspectorates)
• Strong Project Planning/Management skills
• Proven ability to analyze & interpret collective data to provide insights to drive decision-making
• Experience with medical devices pharmaceutical products risk management activities
• Prior experience in R&D and development environment
• Prior leadership of and participation in projects across departments: Strong project management and communication skills
• Conflict Management and Facilitation skills
• Ability to speak present and/or respond before groups of customers employees Regulatory agencies clients and to address common inquiries

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 external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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Manager