Overview
Senior Quality Lead Jobs in Basel, Switzerland at Hays
Title: Senior Quality Lead
Company: Hays
Location: Basel, Switzerland
Background:
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 five 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.
General Information:
Start Date: asap
Latest Possible Start Date: 01.10.2026
Planned Duration of Employment: 1 year
Extension: possible
Workplace: Basel
Workload: 100%
Home Office: Yes, 2 days a week
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 operationalization 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
- Fluency in written and spoken English; bi or multi-lingual skills are desirable
- Clinical Operations experience or quality function in system validations
