Johnson & Johnson

Director, Bioresearch Quality Process Management

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: New Brunswick • California • Florida • United States

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Salary

💰 $150,000 - $258,750 per year

Job Level

Lead

About the role

  • 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.
  • Ensure MedTech R&D Quality Bioresearch procedures comply with industry regulations (e.g., FDA, ISO) and internal policies.
  • 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.
  • 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.
  • 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.
  • 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.
  • Establish and maintain strong relationships with internal and external stakeholders to advocate for Bioresearch quality and process excellence.
  • Establish process for visibility to activity drivers and portfolio.
  • Ownership of creating and maintaining central visibility for budget planning, prioritization and value creation.

Requirements

  • 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
  • Preferred: Leadership in digitalization initiatives and AI application/products
  • Established expertise or experience in process excellence or design, clinical risk management, and process management
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.
  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
bioresearch quality strategyrisk managementprocess optimizationdata analyticsclinical risk managementbioresearch auditsNC/CAPA/Escalationproject managementlean methodologiesprocess excellence
Soft Skills
leadershipinterpersonal skillsteamworkcritical decision-makinginfluencingstrategic alliancesattention to detailresults orientedself-motivatedcross-functional collaboration