Senior Quality Lead

Randstad Switzerland; Basel; Hybrid; CHF 140.000 - 190.000; Vollzeit

Benefits dieser Stelle

Home office 2 days/week

Zusammenfassung

Randstad Switzerland seeks a Senior Quality Lead in Basel to design and implement QA strategies, lead GxP audits, and drive regulatory readiness across molecules, processes, and affiliates. You will ensure quality data supports regulatory decisions and corporate goals, coordinating with global stakeholders.

The ideal candidate has 5+ years guiding GxP audits within pharma/biotech/medical devices, deep drug development knowledge, and strong IS/ audit-reporting skills; English fluency is required,

Qualifikationen

• Bachelor's degree or equivalent in science or quality field.
• 5+ years leading GxP audits and complex quality projects.
• Experience with drug development and global regulations (FDA, EU, ICH).
• Proficient in audit management systems and data reporting.

Aufgaben

• Design and implement quality strategies across programs.
• Lead complex audits and present findings to senior stakeholders.
• Prepare for inspections and support regulatory reviews.
• Collaborate with cross-functional teams to ensure quality standards.

Kenntnisse

GxP audits

Quality leadership

Stakeholder management

Analytical thinking

Ausbildung

Bachelor's degree or equivalent in science/quality

Tools

Audit management systems

Quality data analytics tools

Jobbeschreibung

For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a Senior Quality Lead.

General Information:

• Start Date: ASAP
• Planned Employment Duration: 1 year with the possibility of extension
• Workplace: Basel
• Home Office: Possible, 2 days in a week
• Department: Audit (TLQB)
• Team: 5 people
• Working Hours: Standard

About the job:

The Senior Quality Lead is an experienced Quality Professional who supports the organization through the development and delivery of Quality Assurance strategies, audits, and conclusions for various entities (e.g., molecules in development, post-approval products, affiliates, processes, programs). This role ensures effective implementation of Quality Assurance to stakeholders and Health Authorities by generating evidence and actionable data through complex audits and quality activities.

The perfect candidate:

Possesses extensive experience within the pharmaceutical, biotechnology, or medical device industries, including comprehensive knowledge of product development lifecycles and relevant GxP regulations, such as GCP, GVP, and IVD/MD. They should demonstrate at least 5 years of experience leading GxP audits and managing complex quality projects, complemented by a deep understanding of drug development processes and global regulatory landscapes. Proficiency in information systems—specifically regarding audit management and analysis reporting tools is required, as is prior experience in clinical operations or quality functions related to system validations.

Tasks & Responsibilities:

Design and Implementation of Quality Strategies:

• Establish relationships with business stakeholders and lead the development of molecule/product/process/affiliate-level approaches with appropriate measures (CtQ Factors)
• Analyze quality data to identify trends and risks, providing insights to business partners

Delivery of Activities to Assess Quality Status

• Lead and perform complex audits and quality assessments.
• Synthesize individual audit issues into systematic conclusions and present findings and associated risks to senior stakeholders, ensuring quality data fulfills regulatory requirements and supports organizational goals

Demonstration of Implementation to Health Authorities

• Play a lead role in inspection preparation and management.
• Provide training to staff and ensure relevant materials are prepared for regulatory review

Execution of PDQ Goals

• Lead assigned goals and initiatives and drive the development or revision of PDQ processes

Networking:

• Maintain and influence partnerships with senior business stakeholders and PDQ domains
• Facilitate cross-functional collaboration to ensure quality standards are met globally

Compliance:

• Expert knowledge in GxP regulations (FDA, EU, ICH guidance) and internal policies
• Ensure all activities are conducted in compliance with regulatory and company requirements

Must Haves:

• Bachelor’s degree or equivalent in a scientific or quality-related field. Advanced degree preferred
• Significant experience in the pharmaceutical / biotech / medical device industry, including knowledge of the end to end development and operationalisation of products, and the associated GxP regulations and considerations (e.g., GCP,GVP, IVD/MD Regulations)
• Min. 5 years experience in leading GxP audits and managing complex quality projects
• In-depth knowledge of drug development processes and global regulatory landscapes
• Good understanding of Information Systems, e.g., audit management and analysis reporting tools
• Understanding of business operations and strategies
• Fluency in written and spoken English; bi or multi-lingual skills are desirable
• Clinical Operations experience or quality function in system validations
• Leadership and Stakeholder Management: Demonstrates exceptional ability to influence, negotiate, and mentor while effectively managing relationships with diverse stakeholders in global settings.
• Analytical and Strategic Thinking: strong data and digital literacy, with the critical thinking ability to synthesize complex or ambiguous information into clear, actionable insights.
• Execution and Independence: Combines strong organizational and project management skills with the capacity to work effectively—both independently and collaboratively—within international, agile matrix organizations.
• Communication: Utilizes advanced presentation and communication skills to drive decision-making and foster cross-functional collaboration.

Application Submission Deadline: 25.08.2026