Description

Senior Quality Lead
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 ()
Duration: 12 + Months
Deadline:
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About us:
ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services. jidda9547fob jit0834ob jiy26ob