Manager, Clinical QA Program Lead

Job Description

Johnson & Johnson is recruiting for a Manager, Clinical QA Program Lead. This role can be located in various locations including Raritan, New Jersey, Titusville, New Jersey, Horsham, Pennsylvania, Spring House, Pennsylvania, Allschwil, Switzerland, Beerse, Belgium, High Wycombe, UK, and Madrid, Spain.

Main Responsibilities

• 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 the partnership between audit strategy and execution teams and enhances the value of Clinical audit programs through enhancing the audit report peer review process and the analysis and communications of meaningful audit outcomes.
• Maintains and shares expert-level GCP knowledge with the ability to provide critical information, advice, and guidance on complex quality and compliance issues.
• Leverages data analytics tools to analyze relevant data sources, evaluate and analyze the data to identify any relevant trends and insights as an input for the development of the appropriate audit program.
• 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 the relevant standard procedures, audit scopes, and audit plans are fully understood and applied in audit activities.
• Independently leads and manages the domain-specific compliance audit programs as laid down in a comprehensive audit schedule, through planning, conducting, and reporting of QA audits of activities, data, internal and external facilities and processes in GxP/non-regulated areas to assure adherence to company internal standards and policies/requirements, and compliance with applicable (Health Authority) regulatory requirements.
• This includes for cause, complex and business critical audits.
• Guides auditors in the 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 (or any materials) to share/escalate significant information with senior leaders.
• Proactively seeks solutions and contributes to the strategic direction for the execution of the audit plans, schedule, and inspection-related activities.
• Influences the effective implementation of audit processes ensuring global alignment and harmonization across domains and/or segments.
• Reviews risk profiles, provides expert input to risk management strategies, and translates them into audit plans and audit scope for therapeutic area program(s).
• Provides expert support to auditors and business partners when developing and approving CAPAs. Influences consistency of CAPAs for similar issues.
• Drives resolution of complex CAPAs and acts as mediator between the different functions involved as needed.
• Conducts peer review of audit reports.
• Serves as the primary contact for applicable Clinical QA domain specific activities related to HA Inspections, including inspection readiness and coordinating with other functions as needed.
• Takes an active role in, and leads, projects and teams in key project initiatives across the organization or company.
• Influences stakeholders and determines priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress.
• Effectively drives projects to completion.

Qualifications

• 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 JNJ location.

Preferred Skills

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

Additional Description

• For Pay Transparency 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)).
• Benefits 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
  • 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
• For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits.