General Electric Company

Director, Central Quality Audit, Pharmacovigilance

General Electric Company • $125K — $150K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
5 - 7 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • 5+ years of leadership experience in auditing with a focus on team development.
  • Qualified Lead Auditor with valid certification.
  • Master’s in related field plus 5+ years or Bachelor’s with 10+ years of relevant experience.
  • Proven experience in addressing global quality compliance issues directly.
  • Knowledge of regulatory quality management systems including cGMP, GDP, and GCP.

Responsibilities

  • Develop and maintain a global PV audit strategy aligned with regulatory standards.
  • Oversee all aspects of PV audit operations, from planning to execution and follow-up.
  • Identify compliance risks and provide actionable recommendations to leadership.
  • Support health authority inspections related to pharmacovigilance activities.
  • Track and report on PV audit KPIs to highlight compliance trends.
  • Manage audit-related modules within the electronic Quality Management System.
  • Lead a team of auditors, focusing on coaching and performance management.

Benefits

  • Flexible total rewards designed to support career growth and ambition.
  • Comprehensive medical, dental, and vision coverage.
  • 401(k) plan with employee and employer contributions.
  • Life, disability, and accident insurance included.
  • Tuition reimbursement for continuing education.
Full Job Description
Job Description Summary
Managing, ensuring and improving capabilities to comply with external standards and regulations. Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.

Job Description

Roles and Responsibilities

  • Own the Pharmacovigilance (PV) Audit Program: Develop, implement, and maintain the global PV audit strategy, ensuring alignment with regulatory expectations (e.g., EMA, FDA, MHRA, PMDA) and industry best practices.
  • Manage Audit Operations: Oversee scheduling, planning, execution, reporting, and follow-up for PV audits, including internal audits and audits of service providers and affiliates. Fully participate in the audit program; actively owning and executing PV audits.
  • Risk Identification and Communication: Identify high-risk compliance issues, escalate findings, and provide actionable recommendations to senior leadership.
  • Regulatory Inspection Support: Prepare for and support PV-related health authority inspections, including back-room management and post-inspection follow-up.
  • Metrics and Reporting: Define and track PV audit KPIs, ensuring visibility of compliance risks and trends to leadership.
  • System Ownership: Manage audit-related modules within the electronic Quality Management System (eQMS), including support of configuration, UAT, and documentation.
  • Team Leadership: Lead and develop a team of 3–5 auditors, providing coaching, mentorship, and performance management.
  • Cross-Functional Collaboration: Partner with PV Operations, Quality, and Regulatory teams to ensure audit outcomes drive continuous improvement.
  • Strategic Influence: Contribute to policy development and influence PV compliance strategy across the organization.

Required Qualifications

  • Minimum 5 years of people leadership experience, including team development and performance management.
  • Qualified Lead Auditor with active certification.
  • Master’s degree and 5+ years in pharmacovigilance or pharmaceutical industry; or Bachelor’s degree and 10+ years relevant experience.
  • Minimum of 5 years’ experience driving Global programs to resolve quality compliance issues (directly).
  • Experience with Pharmaceutical QMS requirements and regulatory requirements including but not limited to cGMP, GDP, GPvP, GCP and GLP.

Desired Characteristics

  • Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
  • Prior Veeva and TrackWise Digital experience a plus.
  • Prior health authority experience a plus.
  • IRCA, ASQ (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt).
  • Extensive experience in the Medica Device and Pharmaceutical industry.
  • Understanding of product quality improvement using tools such as Six Sigma, DFR.
  • Demonstrated ability to analyze and resolve problems.
  • Exceptional conflict-resolution skills.
  • Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.
  • Demonstrated ability to lead programs / projects. Ability to prioritize and drive multiple programs.
  • Ability to energize others by building a connection with the team through personal involvement and trust, providing feedback and coaching to develop others, and accountability of actions.
  • Strong oral and written communication skills in English.
  • Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others.
  • Ability to travel globally up to 15%.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

    We will not sponsor individuals for employment visas, now or in the future, for this job opening.

    Additional Information

    Relocation Assistance Provided: No

    About General Electric Company

    GE Healthcare provides medical technology, intelligent devices, and care solutions. They offer medical imaging, information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies. GE Healthcare's mission is to improve patient care and outcomes by providing innovative healthcare solutions. Their technologies are used in hospitals, clinics, research institutions, and pharmaceutical companies worldwide to diagnose and treat various medical conditions.

    General Electric Company Careers

    Join the dynamic team at General Electric Company, a global leader in innovation and technology. As one of the most respected companies worldwide, we offer unparalleled job opportunities that propel your career to new heights. Work You’ll Do At General Electric Company, you’ll be part of a diverse team committed to transforming industries and improving lives through leadership in sectors such as aviation, power, renewable energy, and healthcare. Our culture thrives on innovation and leadership, fostering an environment where you can grow professionally and personally. Lead in a Unique Market Position General Electric Company stands at the forefront of digital and industrial transformation. Here, you’ll leverage your skills to solve complex challenges, drive growth, and lead projects that have a global impact. Our commitment to professional development and diversity training ensures that every team member is equipped to lead and innovate. Collaborate with Industry Experts Work alongside a global network of professionals, each bringing a wealth of knowledge and experience to our collaborative projects. General Electric Company’s culture of inclusivity and teamwork makes it a prime environment for networking and personal development. Innovative Work Join us to work on groundbreaking projects that redefine what’s possible. Our teams at General Electric Company are constantly pushing the boundaries of technology and innovation to create solutions that not only meet but exceed the needs of our customers and communities around the world. Be Part of a Great Team At General Electric Company, we understand that our employees are our greatest asset. That’s why we offer competitive benefits, extensive career advancement opportunities, and a supportive environment that values work-life balance. Our commitment to employee growth is reflected in our robust training programs and our focus on internal mobility. Future-Proof Your Career With a career at General Electric Company, your growth is limitless. Through our various training programs, internships, and leadership development initiatives, you can enhance your skills and advance your career in a direction that aligns with your professional and personal aspirations. Explore Job Opportunities and Internships Whether you’re starting your career or looking to make a significant impact in your field, General Electric Company offers a range of positions and employment opportunities that cater to your talents and ambitions. From internships that provide real-world experience to leadership roles that challenge your strategic thinking, there’s a place for you here. Stay Connected Join Our Team Search open positions that match your skills and interests. We are always on the lookout for passionate, curious, and solution-driven team players. Explore the possibilities that await you at General Electric Company. Keep Up to Date Stay informed with career tips, insider perspectives, and industry-leading insights—all from the people who work here. At General Electric Company, we’re more than a company—we’re a community. Job Alert Emails Customize your subscription to receive job alerts, the latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities available at General Electric Company and become part of a team that’s reshaping the future of technology and industry. Join General Electric Company today and be a part of our journey to build a better world through essential technology and innovative solutions. Your career at General Electric Company awaits—explore, innovate, and lead with us.
    Learn more about General Electric Company
    Size
    168,000 employees
    Market Cap
    $90.4 billion
    Industry
    Business Services
    Net Income
    $5.7 billion
    Founded
    1892
    5 Year Trend
    -9.1%
    Revenue
    $79.6 billion
    NASDAQ
    GE
    * Ladders Estimates

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