Manager, JJEI Quality Risk Management

Johnson & Johnson Innovative Medicine • Hopewell Township, NJ

2d • Hybrid

About The Position

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 https://www.jnj.com/innovative-medicine The 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.

Requirements

• 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.

Nice To Haves

• 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

Responsibilities

• 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.
• 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).
• 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).
• 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager