Senior Quality Lead

Actalent; Basel; Vor Ort; CHF 140.000 - 210.000; Vollzeit

Zusammenfassung

Actalent in Basel, Switzerland is seeking a Senior Quality Lead to drive QA strategies across products, programs, and processes, ensuring compliance with global quality and regulatory standards.

You will lead audits, assess quality risks, and provide guidance to stakeholders, shaping continuous improvement of quality systems and regulatory readiness. This role requires deep GxP expertise and the ability to influence senior leaders and cross-functional teams.

Qualifikationen

• Bachelor's degree in a scientific, life sciences, quality, or related discipline.
• Extensive knowledge of GxP regulations and standards, including GCP, GVP, and IVD/Medical Device regulations.
• Strong understanding of end-to-end product development and commercialization processes.
• Minimum 5 years of experience leading GxP audits and managing complex quality projects.

Aufgaben

• Develop and implement quality assurance strategies for products, processes, programs, and business functions.
• Lead and conduct complex GxP audits and quality assessments across multiple areas.
• Lead inspection preparation activities and support regulatory authority inspections.
• Lead assigned quality initiatives and strategic objectives; drive process improvement.
• Establish and maintain strong relationships with senior stakeholders and quality partners.

Kenntnisse

Quality strategy

Stakeholder engagement

Audit management

Regulatory compliance

GxP knowledge

Data analytics

Cross-functional leadership

Ausbildung

Bachelor's degree in life sciences or related

Tools

Audit management systems

Quality management tools

Data analytics platforms

Jobbeschreibung

Our client is seeking an experienced Senior Quality Lead to drive Quality Assurance strategies across a diverse portfolio of products, programs, processes, and business functions. This role plays a critical part in ensuring compliance with global quality and regulatory standards by designing and executing quality oversight activities, leading complex audits, and providing strategic quality guidance to key stakeholders.

The successful candidate will leverage deep expertise in GxP environments, product development lifecycles, and global regulatory requirements to assess quality risks, generate actionable insights, and support inspection readiness. This position requires a highly collaborative quality professional who can influence senior stakeholders, lead cross-functional initiatives, and contribute to the continuous improvement of quality systems and processes.

Responsibilities

Quality Strategy & Risk Management

• Develop and implement quality assurance strategies for products, processes, programs, and business functions.
• Build strong partnerships with key stakeholders and define quality approaches, including critical-to-quality (CtQ) measures.
• Analyze quality data to identify trends, emerging risks, and opportunities for improvement.
• Provide strategic recommendations to support quality and business objectives.

Audits & Quality Assessments

• Lead and conduct complex GxP audits and quality assessments across multiple areas.
• Evaluate audit findings, identify systemic risks, and consolidate observations into clear quality conclusions.
• Present audit outcomes and risk assessments to senior leadership and stakeholders.
• Ensure quality data and audit evidence support regulatory expectations and organizational goals.

Regulatory Inspection Readiness

• Lead inspection preparation activities and support regulatory authority inspections.
• Ensure relevant documentation, evidence, and training materials are prepared and maintained.
• Provide guidance and training to internal teams on quality and compliance requirements.
• Demonstrate effective implementation of quality systems and processes to regulatory authorities.

Quality Improvement & Process Excellence

• Lead assigned quality initiatives and strategic objectives.
• Drive the development, enhancement, and revision of quality processes and standards.
• Support continuous improvement efforts that strengthen compliance and operational effectiveness.

Stakeholder Engagement & Collaboration

• Establish and maintain strong relationships with senior business stakeholders and quality partners.
• Influence decision-making and promote a culture of quality across the organization.
• Facilitate cross-functional collaboration to ensure consistent quality standards are applied globally.

Compliance & Governance

• Serve as a subject matter expert in GxP regulations, including FDA, EU, and ICH requirements.
• Ensure all quality activities are performed in alignment with regulatory expectations and internal quality standards.
• Monitor evolving regulatory requirements and assess their impact on quality processes and operations.

Must-Haves

• Bachelor's degree in a scientific, life sciences, quality, or related discipline.
• Strong understanding of end-to-end product development and commercialization processes.
• Minimum 5 years of experience leading GxP audits and managing complex quality projects.
• In-depth knowledge of drug development processes and global regulatory frameworks.
• Experience in Clinical Operations and/or quality functions related to computerized system validation and quality oversight.
• Extensive knowledge of GxP regulations and standards, including GCP, GVP, and IVD/Medical Device regulations.
• Strong understanding of global regulatory agency requirements, including FDA, EMA, and ICH guidelines.
• Experience with audit management systems, quality management tools, and data analytics/reporting platforms.
• Solid understanding of business operations, quality governance, and risk management principles.
• Proven ability to influence, negotiate, and build trust with stakeholders at all organizational levels.
• Strong leadership skills with experience mentoring teams and leading cross-functional initiatives.