Director, Bioresearch Quality Process Management

Johnson & Johnson•Brunswick, OH

33d

About The Position

Johnson & Johnson is recruiting for a Director, Bioresearch Quality Process Management , located at one of the identified Johnson & Johnson Medtech sites: New Brunswick, NJ; Mountain View, CA; Cincinnati, OH; Jacksonville, FL; Miami, FL; Raritan, NJ; Irvine, CA; Palm Beach Gardens, FL; Santa Clara, CA and Danvers, MA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The Director, Bioresearch Quality Process Management, is a highly experienced and strategic leader accountable to spearhead Bioresearch related quality process enhancements and governance. In partnership with MedTech Bioresearch R&D Quality functional leads and MedTech Q&C Centers of Excellence, this critical role is instrumental in enabling transparency of bioresearch quality risks across MedTech Business Units, with fit for purpose and standardized quality processes & approaches in support of pre-clinical, clinical, medical safety and pharmacovigilance quality program activities. The role will also ensure compliance with regulatory standards, enhancing product quality, and leading continuous process improvement across the organization. Critical capabilities and experiences include strategic risk governance, stakeholder engagement, process excellence, risk management, and people management. The Director will enable standardization for excellence, efficient and effective leverage of centralized services, drive end-to-end BU line of sight to risk areas, cross BU risk sharing and deployment of improvement strategies.

Requirements

Bachelor’s or equivalent university degree is required
A minimum of 10 years working in regulated environments
Ability to effectively apply project management tools and lean methodologies when leading projects and programs
Excellent leadership skills, self-starting/motivated with highly developed interpersonal and teamwork skills
Ability to quickly process and communicate complex information and make critical decisions with limited information
Experience with strategy execution and implementation, and reporting to executive level leadership
Experience influencing or persuading others to accept new ideas, approaches, or concepts or gains alignment on divergent issues with limited guidance
Experience with Integrations, Clinical quality processes and procedures and systems, including remediation efforts
Established trusted leadership, anticipating business needs and proactively takes actions; leverages relationships; develops strategic alliances
Big picture orientation with attention to detail and results oriented
Ability to work in a matrix and multi-cultural environment
Travel availability up to 20% (domestic and international) is required
English language proficiency (written and verbal) is required

Nice To Haves

Leadership in digitalization initiatives and AI application/products
Established expertise or experience in process excellence or design, clinical risk management, and process management

Responsibilities

Leadership & Strategy: Directly responsible and accountable for supervision and development of direct reports. Develop and implement an integrated bioresearch quality strategy that aligns proactive risk management and MedTech organizational goals to enable process optimization and innovation. Lead the quality process management team to promote a culture of quality and continuous improvement. Strategic oversight of activities and functions responsible for providing centralized visibility and reporting on risk data reporting.
Regulatory Compliance: Ensure MedTech R&D Quality Bioresearch procedures comply with industry regulations (e.g., FDA, ISO) and internal policies.
Bioresearch Quality Process Management: Design and optimize scope of Bioresearch R&D Quality processes and drive risk insights, including Clinical Risk Management, Bioresearch Audits, NC/CAPA/Escalation through cross-functional collaboration within R&D Quality MedTech Bioresearch, MedTech Q&C functions, Subject Matter Experts and cross functional business partners. Identify areas of improvement and implement best practices including business development due diligence, clinical risk management, integration and inspections for bioresearch quality. Responsible for driving innovation and continuous improvement in portfolio bioresearch quality activity processes.
Data Analytics, Reporting & Governance: Establish and utilize data analytics through digitalization and AI to monitor quality metrics and drive decision-making of bioresearch quality activities. Prepare reports for senior management on quality performance and improvement initiatives. Enable cross Business Unit governance of bioresearch quality risks, mitigations and sharing of best practices.
Training & Development: Oversee the development of training programs for staff on bioresearch quality processes and compliance requirements to ensure a knowledgeable workforce. Establish and enable sharing of best practices through communities of practice across MedTech Businesses.
Risk Management: Establish potential risks in pre-clinical/clinical/Med Safety/PV quality systems and processes and implement mitigation strategies to minimize impact and drive innovation. Responsible for owning the process to provide centralized insights on risks, on portfolio quality activities, and reporting processes.
Stakeholder Management: Establish and maintain strong relationships with internal and external stakeholders to advocate for Bioresearch quality and process excellence.
Portfolio & Budget Management: Establish process for visibility to activity drivers and portfolio. Ownership of creating and maintaining central visibility for budget planning, prioritization and value creation.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits