Manager, Clinical QA Program Lead

Jobtailor; Allschwil; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an experienced audit leader to drive and deliver GCP and GxP audit programs in collaboration with global compliance teams. The role emphasizes strategy, execution, and stakeholder alignment within regulated clinical environments.

The position requires a bachelor’s degree and 5+ years in a GxP/compliance field, with hands-on GCP audit experience and the ability to work on-site three days per week at the JNJ location in Basel area.

Qualifikationen

• Bachelor's degree or equivalent required.
• 5+ years in compliance or related R&D GxP field.
• Experience conducting GCP audits.
• Experience developing audit strategies for GCP/Supplier audits.
• On-site work 3 days/week at JNJ location.

Aufgaben

• Audit strategy: Drives and delivers audit strategies and capabilities for applicable therapeutic program level(s), Clinical System, Clinical Supplier, or Local Operating Company audits.
• Fosters partnership between audit strategy and execution teams and enhances the value of Clinical audit programs.
• Monitors audit outcome trends and identifies collaboration opportunities with stakeholders to resolve compliance related matters.
• Conducts GCP audits and supports GxP audits as applicable (up to 50% time).
• Develops tactical and operational audit plans to implement and deliver domain-specific audit strategies.
• Independently leads and manages domain-specific compliance audit programs as laid down in a comprehensive audit schedule.
• Guides auditors in the scope definition, planning, conduct and reporting of audits.
• Prepares and reviews audit summary reports to share/escalate significant information with senior leaders.

Kenntnisse

GCP audits

Audit strategy

GxP compliance

Stakeholder collaboration

Ausbildung

Bachelor's degree

Jobbeschreibung

Audit 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.
• Fosters the partnership between audit strategy and execution teams and enhance the value of Clinical audit programs.
• Monitors audit outcome trends and identifies collaboration opportunities with stakeholders to resolve compliance related matters.
• Conducts GCP audits & supports GxP Audits as applicable (expected up to 50% time).
• Develops tactical and operational audit plans to implement and deliver domain-specific audit strategies.
• Independently leads and manages domain-specific compliance audit programs as laid down in a comprehensive audit schedule.
• Guides auditors in the scope definition, planning, conduct and reporting of audits.
• Prepares and reviews audit summary reports to share/escalate significant information with senior leaders.

Requirements

• A minimum of a bachelor’s or equivalent University degree is required.
• Requires 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.

Core Competencies

Demonstrates expertise in developing and executing audit strategies within GxP-regulated environments, with a strong focus on GCP audits and compliance. Capable of leading audit programs, preparing comprehensive reports, and fostering collaboration among stakeholders.