Manager, Clinical QA Program Lead (2 openings)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity.

This position can be located in Raritan or Titusville, NJ; Horsham or Spring House, PA; Allschwil, Switzerland; Beerse, Belgium; High Wycombe, UK; Shanghai, China; or Madrid, Spain.

Responsibilities

• Audit Strategy
  • Drives and delivers audit strategies and capabilities for applicable therapeutic program level(s), Clinical System, Clinical Supplier, or Local Operating Company audits, ensuring connectivity and holistic alignment of strategies.
  • Fosters partnership between audit strategy and execution teams and enhances the value of Clinical audit programs through improving the audit report peer review process and analyzing and communicating meaningful audit outcomes.
  • Monitors audit outcome trends and identifies proactive collaboration opportunities with stakeholders to resolve compliance-related matters and enhance audit strategy and overall quality of clinical programs across therapeutic areas.
  • Maintains and shares expert-level GCP knowledge, providing critical information, advice, and guidance on complex quality and compliance issues.
  • Leverages data analytics tools to analyze relevant data sources, evaluate trends, and derive insights for developing appropriate audit programs.
• Audit Execution
  • Conducts GCP audits and supports GxP Audits as applicable (expected up to 50% time) with a focus on audits relevant to the responsible therapeutic areas.
  • Develops tactical and operational audit plans to implement and deliver domain-specific audit strategies.
  • Ensures relevant standard procedures, audit scopes, and audit plans are fully understood and applied in audit activities.
  • Independently leads and manages domain-specific compliance audit programs through planning, conducting, and reporting of QA audits to assure adherence to company standards and regulatory requirements, including for-cause, complex, and business-critical audits.
  • Guides auditors in scope definition, planning, conduct, and reporting of audits, providing regulatory and process expertise within the applicable therapeutic area program(s).
  • Prepares and reviews audit summary reports to share or escalate significant information with senior leaders.
  • Contributes to the strategic direction for the execution of audit plans, schedules, and inspection-related activities, influencing global alignment and harmonization.
  • Reviews risk profiles, provides expert input to risk management strategies, and translates them into audit plans and scopes for therapeutic area program(s).
  • Provides expert support to auditors and business partners in developing and approving CAPAs, driving resolution of complex CAPAs, and acting as a mediator between functions as needed.
  • Conducts peer reviews of audit reports.
• Inspection Support
  • Serves as the primary contact for applicable Clinical QA domain-specific activities related to Health Authority (HA) Inspections, including inspection readiness and coordination with other functions.
• Project Management
  • Leads projects and teams in key initiatives across the organization or company.
  • Influences stakeholders, determines priorities, checkpoints, and timelines for all aspects of work and projects to ensure adequate progress and completion.

Requirements

• A minimum of a bachelor’s or equivalent university degree is required.
• At least 5 years’ experience in an applicable compliance field and/or equivalent time and experience in a related R&D area (GxP-regulated discipline).
• Experienced in conducting GCP audits.
• Experienced in developing audit strategies and capabilities for applicable therapeutic program level(s), GCP System, and/or GCP Supplier audits.
• Must be able to work onsite 3 days/week at a JNJ location.

Benefits

• Time Off
  • Vacation: 120 hours per calendar year
  • Sick time: 40 hours per calendar year (48 hours for Colorado residents; 56 hours for Washington residents)
  • 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
• Retirement & Savings
  • Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)), subject to the terms of their respective plans.

Pay

The anticipated base pay range for this position is $102,000.00 - $177,100.00.