Team Lead

vor 7 Monaten


Basel, Schweiz Coopers Group AG Vollzeit

Team Leader - GxP Audit

We are seeking a qualified Lead Auditor to play a pivotal role in our GxP (Good Clinical, Laboratory, Manufacturing, Pharmacovigilance, and Distribution Practices) Audit Team. As the Lead Auditor, you will be responsible for the planning and execution of audits to evaluate GxP compliance, including GCLP, GCP, GDP, GMP, and GVP, in line with CSV (Computer System Validation) requirements.

**Responsabilities**:

- GxP Audit Planning: Collaborate with GxP Audit Program Owners and Quality Subject Matter Experts to define the GxP Annual Audit Plan.
- Audit Execution: Lead and oversee the execution of audits as per the annual audit program, ensuring adherence to standard operating procedures (SOPs) and department manuals.
- Audit Resource Management: Ensure that audits are properly staffed, conducted, and reported in compliance with established procedures.
- Audit Deliverables: Review draft audit plans and reports, and oversee the timely closure of audits, including the review and approval of Corrective and Preventive Action (CAPA) plans.
- Risk Management: Identify and escalate compliance issues and risks to senior management when necessary.
- Inspection Management Strategy: Contribute to the development and execution of the Inspection Management Strategy by collaborating with Global Process Owners (GPOs) and other Quality department leaders.
- Regulatory Authority Inspections: Support the preparation for and hosting of regulatory authority inspections, as needed.
- Knowledge Sharing: Provide key insights and strategic information derived from internal and external audits and related processes on a regular basis.
- Regulatory Knowledge: Stay informed about company policies, SOPs, drug development, manufacturing, distribution, FDA and EU regulations, and relevant international standards such as ICH guidance.
- Lead Auditor: Act as the Lead Auditor when required.
- Team Leadership: Lead and mentor the QA Auditor Team

**Your profile**:

- A university degree in Life Sciences or a related field.
- A minimum of 15 years of experience in the pharmaceutical industry, including responsibilities related to GxP compliance.
- Proficiency in conducting GxP audits and inspections.
- In-depth knowledge of GMP, GDP, GLP, and familiarity with EU, US, and RoW regulations.
- Exceptional verbal and written communication skills.
- Desired: Prior experience as an Inspector or in managing auditor teams.

Sounds like a great job?



  • Basel, Schweiz Brenntag Vollzeit

    **TEAM LEAD CHEMICAL WAREHOUSE**: Our team in **Basel** currently has an opening for a **Team Lead Chemical Warehouse** **YOUR ROLE & RESPONSIBILITIES**: - Fachliche und disziplinarische Führung der Mitarbeitern - Organisation, Steuerung und Kontrolle der auftragsbezogenen Produktionsprozesse - Organisation der Warenein - und Ausgänge im Bereich Bulk und...

  • Team Leader Facility

    vor 4 Wochen


    Basel, Schweiz AMAC Aerospace Switzerland AG Vollzeit

    **Your daily tasks & responsibilities** - Work on an operational level as Team Leader & be responsible for the following areas / tasks - all maintenance work (e.g. mending of electronic installations, paint jobs etc.) are handled properly and in time - all routine landscaping tasks are handled properly and in time - company cars are being refueled and...


  • Basel, Schweiz Digitec Galaxus AG Vollzeit

    **Team Leader Post Department**: - Zürich - 80% - 100% - After Sales Service - Deutsch Willst du bei der Nummer 1 im Schweizer Onlinehandel mitarbeiten? Digitec Galaxus AG legt grossen Wert auf zufriedene Kunden und optimiert daher kontinuierlich die Prozesse. Als Team Leader Post Department hast du die einmalige Möglichkeit, eine zentrale Rolle bei der...


  • Basel, Schweiz Richemont Vollzeit

    Code de référence: 85624**Team Leader Customer Contact**: - Richemont- Neuchatel, NE, CH- PermanentRichemont, l’un des leaders mondiaux dans le secteur du luxe, possède différentes Maisons spécialisées dans la joaillerie, l’horlogerie et les accessoires haut de gamme. Chaque Maison incarne fièrement une tradition de style, de qualité et...

  • Technical Team Lead

    vor 7 Stunden


    Basel, Schweiz Oliver James Associates Vollzeit

    A well known **Health care Company **based in **Basel **is looking for a **Technical Team Leader **to join their growing company. A small but motivated company with 300 employees looking to provide patients with digital health solutions across Switzerland and Germany. After operating in these markets for around 20 years, they are looking to take there...


  • Basel, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

    **About Idorsia Pharmaceuticals Ltd** Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core. Headquartered in Switzerland - a European biotech hub -...


  • Basel, Basel-Stadt, Schweiz Straumann Group Vollzeit

    Job Title: Regulatory Affairs Team LeadAbout the Role:We are seeking a highly skilled Regulatory Affairs Team Lead to join our team at Straumann Group. The successful candidate will be responsible for ensuring that all products in scope are designed, manufactured, and distributed in accordance with applicable regulatory requirements.Main Responsibilities:*...


  • Basel, Schweiz Skillhubs Vollzeit

    As a Manufacturing Team Leader, you will spearhead a dynamic team of Manufacturing Associates, orchestrating day-to-day operations with precision and a steadfast commitment to **cGMP compliance** and safety standards. Your role is crucial in upholding the integrity of our manufacturing processes, serving as a linchpin for technical problem-solving and...


  • Basel, Schweiz OnTarget Communications Vollzeit

    **Location**:Basel, Switzerland **Relocation Supported**:Yes **Job Title**:Aircraft Maintenance Team Lead for Gulfstream **Benefits**: - Opportunities for professional development including free English lessons - Minimum five weeks of holiday time each year - Subsidised meals in on-site cafeteria and additional employee discounts - Free shuttle bus...

  • Consulting Content Lead

    vor 7 Monaten


    Basel, Schweiz Roche Vollzeit

    The Position Position Summary: This is a unique position, designed to drive ongoing development and performance in the P&OG Consulting AoP, specifically in the Team Effectiveness space. The Consulting Content Lead has the following responsibilities: Establish consistent best practices in the area of Team Effectiveness and the supporting...

  • Gcp Team Lead Basel

    vor 7 Monaten


    Basel, Schweiz Novartis Vollzeit

    390761BR **GCP Team Lead Basel**: Switzerland **About the role** 5600 scientists working on over 300 discovery programs in 8 disease areas focusing on 90 new molecular entities makes BioMedical Research (BR), Novartis the premier place to develop your career as a pharmaceutical professional. If you are curious, scientifically minded, and want to...


  • Basel, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Team Leader Air Freight

    vor 3 Monaten


    Basel, Schweiz AIT Worldwide Logistics, Inc. Vollzeit

    Introduction: **Move the world with us!** AIT is a global freight forwarding and logistics company headquartered in Chicago. Are you looking for an exciting and varied job? Then you are exactly right for us! Become part of the international supply chain and move the world with us! Does that sound interesting? Then make AIT Worldwide Logistics the next stop...


  • Basel, Schweiz Roche Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...


  • Basel, Schweiz Novartis Vollzeit

    393659BR **Clinical Document Management: Migration Team Lead**: Switzerland **About the role** We are seeking a CDM Migration Team Lead to join our CDM team reimagining TMF at Novartis! This position is accountable for leading business activities relating to data migrations in and out of Novartis electronic Document Management Systems (eDMS), ensuring...

  • Team Leader

    vor 7 Monaten


    Basel, Schweiz 5 palate GmbH Basel Vollzeit

    **Team Leader / Restaurant Manager** Your tasks Operational management of the catering department in cooperation with the kitchen team management Ensuring customer-oriented and professional guest care (active collaboration in gastronomy) Management of a team of approx. 10 people Creation of work plans Planning, organization and implementation of events in...


  • Basel, Basel-Stadt, Schweiz Roche Vollzeit

    Job Description:The position of Strategic Team Effectiveness Lead at Roche is a unique opportunity for a seasoned professional to drive ongoing development and performance in the P&OG Consulting AoP, specifically in the Team Effectiveness space.Responsibilities:Establish consistent best practices in the area of Team Effectiveness and ensure they are...

  • Team Leader Fitness

    Vor 2 Tagen


    Basel, Schweiz Decathlon Switzerland Vollzeit

    **POSITION**: Team Leader (m/w) **NETWORK**: Running - Fitness **START**: Ab März oder nach Vereinbarung -------------------------------------------------------------------------------- - WER SIND WIR? Wir sind Decathlon - einer der größten Sportartikelhersteller und -händler der Welt! Gemeinsam machen wir die Sportwelt blau, und das seit 1976. Uns...


  • Basel, Schweiz Straumann Group Vollzeit

    **Job Purpose** As Team Leader Regulatory & Compliance - Regenerative Solutions, you will be part of a small but highly motivated and very international team, dedicated to our regenerative product portfolio. With your regulatory and compliance knowledge, you will support product developments and life cycle activities for the regenerative portfolio in order...


  • Basel, Schweiz Idorsia Pharmaceuticals Ltd. Vollzeit

    **About Idorsia Pharmaceuticals Ltd** Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core. Headquartered in Switzerland - a European biotech hub -...