Senior Quality Lead

Flexsis; Basel; Hybrid; CHF 150.000 - 190.000; Vollzeit

Benefits dieser Stelle

Home office 2 days/week

Zusammenfassung

Flexsis is recruiting for Roche in Basel for a Senior Quality Lead to drive GxP audits and quality programs. The role focuses on establishing molecule/product/process audit strategies, leading complex audits, and ensuring regulatory compliance with health authorities.

You will interact with senior stakeholders and guide quality improvements in a Basel setting. The position offers hybrid work with home office 2 days per week, a 1-year term with possible extension, and immediate start options.

Qualifikationen

• Bachelor’s degree or equivalent in a scientific or quality-related field (advanced degree preferred).
• 5+ years leading GxP audits and managing complex quality projects.
• Deep knowledge of drug development processes and global regulatory landscapes.
• Experience with audit management and regulatory reporting tools.

Aufgaben

• Lead development of molecule/product/process audit approaches with CtQ factors.
• Analyze quality data to identify trends and risks for senior stakeholders.
• Lead audits and quality assessments and manage inspection readiness.
• Synthesize audit findings into systemic conclusions and present risks to executives.
• Ensure regulatory data supporting quality goals and health authority demonstrations.

Kenntnisse

GxP audits

Regulatory knowledge

Quality leadership

Data analysis

Ausbildung

Bachelor’s degree or equivalent in a scientific/quality field

Advanced degree preferred

Tools

Audit management software

Regulatory reporting tools

Jobbeschreibung

Flexsis is a company of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise as well as the competencies within the Interiman Group, we offer tailored solutions in personnel consulting.

For our client Roche in Basel, we are looking for a reliable and motivated (m/f/d)

Senior Quality Lead

• Start Date: asap


• Latest Possible Start Date: 01.10.2026


• Planned Duration of Employment: 1 year


• Extension: possible


• Workplace: Basel


• Home Office: Yes: 2 days a week

Tasks & Responsibilities:

• 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

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