Senior Quality Lead

ITech Consult AG; Basel; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

ITech Consult AG in Basel seeks a Senior Quality Lead to architect and implement Quality Assurance strategies across molecule/product development and affiliates, leading GxP audits and ensuring inspection readiness. You will partner with global stakeholders, synthesize audit findings into actionable insights, and drive risk-based quality improvements across the organization.

The ideal candidate brings 5+ years of GxP audit leadership in pharma/biotech/medical devices, deep drug development and

Qualifikationen

• Bachelor's degree or equivalent in a scientific or quality-related field.
• 5+ years of leading GxP audits and managing complex quality projects.
• Deep knowledge of drug development processes and global regulatory landscapes.
• Proficiency with audit management and analysis reporting tools.
• Fluency in written and spoken English; German is a plus.

Aufgaben

• Design and implement Quality Strategies with CtQ measures.
• Lead and perform complex GxP audits and quality assessments.
• Synthesize audit findings into regulatory-friendly conclusions for senior stakeholders.
• Drive inspection readiness and management, including Health Authority interactions.
• Provide staff training and ensure regulatory materials are prepared for review.
• Coordinate cross-functional collaboration to meet global quality standards.

Kenntnisse

QA Leadership

GxP Audits

GxP Regulations

Audit Management

Stakeholder Mgmt

English Fluency

Ausbildung

Bachelor's degree in science or quality

Tools

Audit management systems

Jobbeschreibung

Senior Quality Lead: Quality Assurance / GxP audits / audit management / GCP / GVP / IVD/MD /Clinical Operations / Stakeholder Management / English / German

Background:

The Senior Quality Lead is an experienced Quality Professional who supports the Roche/Genentech 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.

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) (
• 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.

Reference Nr.: 925166
Rolle: Senior Quality Lead
Industrie: Pharma
Location: Basel
Pensum: 100%
Start: ASAP (01.10.2026)
Duration: 12 + Months
Deadline: 24/08/2026