Quality Manager

Vor 3 Tagen

Basel, Schweiz Panda Vollzeit

Quality manager Job description

**Quality Manager (f/m/d) 100%**
A leading contract development and manufacturing partner (CDMO) for biotech and pharma customers is seeking a Quality Manager. The role involves commissioning, qualification, and process validation of a new manufacturing facility, as well as establishing the quality management system and processes to ensure compliance with national/international requirements and cGMP standards.

**Main responsibilities**:

- Involved in quality-related activities for manufacturing processes
- Review and approval of documents such as Standard Operating Procedures, Master Manufacturing Batch Records, Deviation Reports, Change Requests, Qualification/Validation Protocols and Reports, etc.
- Ensure appropriate investigation and recording of manufacturing deviations
- Manage investigations of customer product complaints and ensure timely completion of documentation
- Drive completion of Corrective and Preventive Actions (CAPA) and effectiveness check items
- Perform Batch record reviews for Drug Substance and Drug Product on behalf of the Responsible Person
- Evaluate product-related changes, assess relevance to regulatory filings, provide change notifications, and approve change requests
- Manage life cycle management of all manufactured products in compliance with GMP
- Represent QA in project/tech transfer teams for new manufacturing processes
- Support and participate in internal and external audits, including inspections by health authorities
- Identify emerging QA topics, communicate to the organization, and contribute to the development of Quality and Compliance strategies and standards
- Support GMP training programs
- Promote a strong Quality culture within the organization

**Your profile**:

- Bachelor's or Master's degree in biotechnology, pharmacy, life science, or related field
- Over 3 years of experience in the GMP regulated pharmaceutical industry, preferably in a quality and compliance role in production and CAPEX projects
- Strong knowledge of GMP regulations
- Strong team orientation
- Structured, focused, and well-organized working attitude
- Open-mindedness for new ideas and suggestions
- Agile, highly motivated, and dynamic drive
- Solution-oriented mindset
- Experience in representing Quality and Compliance in the operational manufacturing environment
- General knowledge of manufacturing processes and analytical methods
- Ability to identify non-compliance with quality standards during project execution
- Ability to prioritize and manage work in a fast-paced environment with critical project timelines
- Good operational level of English, German language skills are an asset

**Organization and offer**:
The organization is a prominent contract development and manufacturing partner (CDMO) in the biotech and pharma industry. With headquarters in Basel, Switzerland, and production facilities in Denmark and Switzerland, they are dedicated to enabling their biotech and pharma customers to deliver life-changing treatments to patients. Setting themselves apart as the first CDMO globally to offer a complete supply chain for manufacturing live bacteria strains for therapeutic use, they bring together exceptional capabilities and expertise.

  • Quality Manager

    vor 2 Wochen

    Basel, Schweiz PM Group Teilzeit

    Overview We are seeking an experienced Quality Manager to oversee site quality matters for a pharmaceutical construction project in Switzerland. This role requires a seasoned professional to establish/maintain the highest quality standards throughout the construction and commissioning phases of a pharmaceutical manufacturing facility. Responsibilities The...

  • Quality Manager

    vor 1 Woche

    Basel, Schweiz PM Group Vollzeit

    Overview We are seeking an experienced Quality Manager to oversee site quality matters for a pharmaceutical construction project in Switzerland. This role requires a seasoned professional to establish/maintain the highest quality standards throughout the construction and commissioning phases of a pharmaceutical manufacturing facility. Responsibilities The...

  • Quality Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Novartis Pharma GmbH Vollzeit CHF 100'000 - CHF 150'000 pro Jahr

    Job ID REQ Nov 19, Schweiz Summary Location: Basel, Switzerland #onsite Role Purpose: Manage independently technical development projects and related processes to support departmental portfolio, projects and objectives according to agreed timelines and standards within Technical Research & Development (TRD About the Role Major accountabilities: Manage...

  • Quality Manager We

    vor 2 Wochen

    Basel, Schweiz PM Group Vollzeit

    **Quality Manager WE**: - Permanent - Basel, Switzerland - Engineering - 5277 **Overview - We wish to appoint a Quality Manager to support the expanding business in Western Europe (WE).- The Quality Manager will be responsible for implementing and monitoring PM Group’s Quality Management System (QMS) and for driving excellent and consistent service...

  • Quality Manager We

    vor 2 Wochen

    Basel, Schweiz PM Group Vollzeit

    : - We wish to appoint a Quality Manager to support the expanding business in Western Europe (WE). The Quality Manager will be responsible for implementing and monitoring PM Group’s Quality Management System (QMS) and for driving excellent and consistent service delivery across all WE business units and associated sites. The successful applicant will...

  • Quality Assurance Manager

    Vor 3 Tagen

    Basel, Schweiz ITech Consult Vollzeit

    **Project**: For our customer a big pharmaceutical company in Basel we are looking for a highly qualified **Quality Assurance Manager (M/F/d).** **Background**: As part of the Quality Unit on-site, the team QA Facility & Engineering ensures GMP compliance of all production facilities at the Basel Drug Substance Manufacturing site. The team’s...

  • Quality Manager

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Novartis Vollzeit CHF 90'000 - CHF 120'000 pro Jahr

    Job Description SummaryLocation: Basel, Switzerland #onsiteRole Purpose:Manage independently technical development projects and related processes to support departmental portfolio, projects and objectives according to agreed timelines and standards within Technical Research & Development (TRD).Job Description Major accountabilities: Manage project related...

  • Quality Assurance Manager

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Work Selection Vollzeit CHF 90'000 - CHF 120'000 pro Jahr

    Für unseren renommierten Geschäftspartner, die F. Hoffmann-La Roche in Basel, suchen wir als First-Tier-Supplier per sofort einen motivierten und engagiertenQuality Assurance Managerfür einen unbefristeten Einsatz.Der Bereich Basel Drug Substance am Konzernhauptsitz in Basel ist in verschiedene Produktionseinheiten für monoklonale Antikörper (MAB),...

  • Quality Assurance Manager/in

    vor 2 Wochen

    basel, Schweiz ELAN Personal AG Vollzeit

    Quality Assurance Manager/in Hintergrund:Der Bereich Basel Drug Substance am Konzernhauptsitz in Basel ist in verschiedene Produktionseinheiten für monoklonale Antikörper (MAB), Single-Use Technology (SUT) und Antibody Drug Conjugates (ADC) gegliedert. Innerhalb dieser dynamischen Umgebung stellt das Quality Assurance (QA) Team die Einhaltung höchster...

  • Quality Manager

    Vor 3 Tagen

    Basel, Schweiz Jobs via eFinancialCareers Vollzeit

    Apply for the Quality Manager - Swisslinx role at Jobs via eFinancialCareers. Job Description Start: ASAP Duration: 6 months Location: Basel Responsibilities Serve as the primary quality contact for all communications related to drug substance and drug product PPQ. Review and approve PPQ documentation including protocols, reports, and discrepancies. Review...