Senior Quality Lead

Gi Group; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Gi Group in Basel seeks an experienced Senior Quality Lead with a strong background in pharmaceutical, biotech, or medical device industries. The role focuses on driving quality strategy, leading GxP audits, ensuring inspection readiness, and partnering with global stakeholders to uphold the highest quality and compliance standards.

The position requires at least 5 years of experience in leading GxP audits, extensive regulatory knowledge (GCP, GVP, IVD/MD, FDA/EU/ICH), and proven ability to

Qualifikationen

• Bachelor's degree in a scientific or quality-related field.
• Advanced degree preferred for higher accountability.

Aufgaben

• Develop and implement quality strategies across products, processes, and affiliates.
• Lead complex GxP audits and quality assessments.
• Present audit findings and recommendations to senior stakeholders.
• Drive continuous improvement through quality oversight and risk-based decision making.
• Lead inspection preparation and support health authority interactions.

Kenntnisse

GxP audits

Quality leadership

Stakeholder management

Regulatory knowledge

Audit management

Ausbildung

Bachelor's degree

Advanced degree preferred

Tools

Audit management systems

Jobbeschreibung

We are seeking an experienced Senior Quality Lead with a strong background in the pharmaceutical, biotechnology, or medical device industry. This role focuses on driving quality strategy, leading complex GxP audits, ensuring inspection readiness, and partnering with global stakeholders to maintain the highest quality and compliance standards.

Location: Basel

Contract: 1 year (extension possible)

Tasks & Responsibilities

Quality Strategy & Risk Management

• Develop and implement quality strategies across products, processes, and affiliates.
• Analyze quality data, identify trends and risks, and provide actionable insights.
• Establish strong partnerships with business stakeholders and define CtQ measures.

Audits & Quality Assessments

• Lead complex GxP audits and quality assessments.
• Present audit findings, risks, and recommendations to senior stakeholders.
• Drive continuous improvement through quality oversight and risk-based decision making.

Inspection Readiness & Compliance

• Lead inspection preparation and support health authority interactions.
• Deliver quality and compliance training to relevant teams.
• Ensure compliance with GxP regulations, including GCP, GVP, FDA, EU, and ICH requirements.

Stakeholder Management & Continuous Improvement

• Collaborate across global functions to ensure quality standards are met.
• Lead quality initiatives and support the development of PDQ processes.
• Influence senior stakeholders and promote a culture of quality excellence.

Requirements

• Bachelor's degree in a scientific or quality-related field; advanced degree preferred.
• Significant experience in the pharmaceutical, biotech, or medical device industry.
• Minimum 5 years of experience leading GxP audits and complex quality projects.
• Strong knowledge of GCP, GVP, IVD/MD regulations, drug development, and global regulatory requirements.
• Experience with audit management and quality reporting systems.
• Clinical Operations experience and/or quality experience in system validations.
• Excellent stakeholder management, communication, and leadership skills.
• Fluent in English; additional languages are an advantage.