Director Quality

Vor 6 Tagen


Basel, Schweiz Elanco Vollzeit

Education : EQUIVALENTEXPERIENCE

**As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.**

**Position Description**:
Provide leadership and oversight to a team of EEM Quality Assurance staff responsible for the quality oversight of third party CMOs manufacturing product for Elanco Animal Health Inc. to ensure they are effective and compliant with the relevant regulatory and company requirements. Drive continuous improvement of quality systems and processes pertaining to external manufacturing. The role is based in Basel, Switzerland, with oversight of external partners located primarily in Europe.

**Functions, Duties, Tasks**:
Main Responsibilities
- To lead a team of QA Third Party Managers and Specialists working within the EMEA region which includes duties such as: Setting priorities, assigning of duties, performance monitoring and management, staff training and development
- Ensure that team members follow internal company requirements, such as Ethics & Compliance, HSE and Finance, and demonstrate commitment to company values with a high level of demonstrated professionalism, integrity, and trust.
- Responsible for Quality oversight to external suppliers and third parties manufacturing product for Elanco to ensure that the delivered products comply with valid quality standards and legal requirements.
- Enable the robust selection and onboarding of third-party manufacturers or suppliers in compliance with both the regulatory/GMP requirements in alignment with Elanco Global Quality Standards and Procedures.
- Support product launches and manufacturing site transfers in compliance with internal and external requirements. Ensure Quality input to and evaluation of qualification and validation activities at third party manufacturers.
- Proactively monitor Key Performance Indicators (KPI) for suppliers and contractors to detect and address quality signals before compliance issues arise.
- Ensure in association with other relevant personnel that Product Quality Reviews/Annual Product Reviews are completed according to the required timelines.
- Implement continuous improvement initiatives associated with quality systems to ensure they are both robust and effective and enable appropriate levels of supplier monitoring and product quality performance.
- Engage with Elanco Global Quality Auditing and Compliance (EGQCA) to prepare for audits and manage CMOs relationships to ensure completion of appropriate CAPA plans.
- To ensure that all necessary QA instruments for the sourcing of GMP products from suppliers and contractors (e.g. Quality Agreements, Supplier Risk Assessments, Product Quality Reviews) are in place.
- Engage in resolution of manufacturing deviation investigations and CAPA identification to prevent reoccurrence. Manage and support Change Control activities. Complete Notification to Management as required for quality issues.
- Partner with Regulatory, Technical Services & Manufacturing Sciences, and external partners on regulatory submissions.

**Minimum Qualification (education, experience and/or training, required certifications)**:

- Bachelor’s degree in pharmacy or life science related field from reputable university
- Minimum 6 -year experience in pharmaceutical industry and QA operations.
- Thorough knowledge in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and regulatory requirement
- High flexibility to adjust quickly and effectively to frequent change and altered priorities, and able to work under pressure and compliance with strict deadlines
- German, English

**Additional Preferences**:

- Ideally French
- Knowledge of Quality Control, technical experience in manufacturing
- Experience with SAP and other Pharmaceutical Software systems such as TrackWise
- Knowledge of MS Excel, Word and Power Point

**Other Information**:

- Direct reports: approx. 7
- Travel: 10%

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status


  • Director Digital Quality

    vor 7 Monaten


    Basel, Schweiz Panda International Vollzeit

    **Director Digital Quality**: **Location** - Basel, Switzerland **Business Sector** - Biotechnology **Job ref** - 22276 **Published** - about 5 hours ago **Director Digital Quality** Are you a professional with expertise in digital quality management within the Pharmaceutical and Biotechnology manufacturing industry? Join a top-tier organization in...


  • Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Reporting to the Head Quality, International Organization, the Director of Quality Assurance Disposition will be responsible for providing QA oversight and support of Moderna’s international organization’s product disposition for clinical and commercial product manufactured at contract manufacturing organizations (CMO) and tested at...


  • Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Gi Group SA is seeking a highly experienced Senior Quality Assurance Director to join our team in Basel, Switzerland.About the RoleThis is a unique opportunity for a seasoned quality professional to lead our Quality Assurance team and drive excellence in quality management. As Senior Quality Assurance Director, you will be responsible for ensuring the...


  • Basel, Schweiz Ridgeline Discovery GmbH Vollzeit

    **Ridgeline Discov**ery is looking for an (Associate) Director, Quality Assurance**. Ridgeline Discovery, a Versant Ventures Discovery Engine, creates and operates Versant-financed innovative biotech companies in partnership with entrepreneurs, industry, and leading academics across Europe. In recent years, Ridgeline has assembled an international team of \...


  • Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Reporting to the Sr Director, Global Quality Operations, the Director, Product Quality Lead will be responsible for providing quality oversight of drug products throughout the product and design control lifecycle. Develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality and design control risks....


  • Basel, Schweiz Moderna Vollzeit

    The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide,...


  • Basel, Schweiz BeiGene Vollzeit

    General Description:_ The position will report to the Senior Director, Distribution Quality, will provide GDP/GSP expertise and manage day to day operations for distribution of IMPs and commercial products globally for BeiGene. The incumbent will ensure that clinical and commercial products are supplied to these markets in accordance with regulatory...


  • Basel, Schweiz Veristat Vollzeit

    Job Description: Associate Director Quality Assurance and Compliance The Associate Director, Quality Assurance and Compliance (QAC) - Europe serves as the operational manager to direct, oversee, and manage all European clinical quality assurance (QA) activities, and provides hands on administration and management of Quality Systems and ensures compliance...


  • Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Reporting to the Director, Product Quality Lead the Associate Director, Product Quality Lead will be responsible for developing, approving, monitoring and maintaining critical quality standards, identifying quality risks, ensuring quality management of product and processes lifecycle, leading improvement and alignment with current regulatory...


  • Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Reporting to the Director of Quality Management Systems, the Quality Standards and Policies Associate Director is responsible for enabling quality and compliance excellence by interpreting regulatory intelligence to support translation into the necessary Quality Standards. Working in collaboration with key stakeholders in Quality and across...


  • Basel, Schweiz Moderna Therapeutics Vollzeit

    The Role Critical Raw Material (CRM) play an essential role for our Product Quality impacting across all our programs. Reporting to the Sr Director - Product Quality, the A/Director - Product Quality Lead (PQL) will be responsible for providing end-to-end quality oversight to our critical raw material. Develop, approve, monitor, and maintain critical...


  • Basel, Schweiz J. Wagner GmbH Vollzeit

    WAGNER - Powered by Talents Mit weltweit mehr als 2.000 Mitarbeitenden an 19 Standorten sind wir einer der marktführenden Hersteller innovativer Beschichtungstechnik. Heimwerker, Handwerker und Industriekunden auf der ganzen Welt vertrauen auf unsere innovativen Produkte, die Ressourcen schonenden Technologien und unseren persönlichen, schnellen Service....


  • Basel, Schweiz Proclinical Vollzeit

    Proclinical are proud to announce our exclusive partnership with Ultragenyx Pharmaceuticals in support of their ongoing European expansion. Ultragenyx are a US based biotech committed to the development of innovative therapies for patients with serious rare and ultra-rare genetic diseases. Their unique approach has led to the successful development of...


  • Basel, Schweiz Moderna Vollzeit

    The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide,...


  • Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Reporting to the Sr. Director of Global Quality Control Standards and Policies, the Associate Director, Global QC Change Controls (& Deviations), will be collaborating closely with Moderna’s network of QC Laboratories, internal and external (affiliated Contract Testing Organizations (CTOs)/Contract Manufacturing Organization (CMOs)), with the...


  • Basel, Schweiz BeiGene Vollzeit

    General Description: The Associate Director of R&D Quality Systems, Strategy, and Excellence (International & Affiliate) plays a pivotal role in ensuring the consistent implementation and alignment of global quality policies, procedures, and GxP standards at the local and regional levels. This global position is responsible for supporting local affiliates...


  • Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Reporting to the Senior Director, Global Sterility Assurance, the Director, Global Sterility Assurance, will be providing technical and compliance leadership, collaborating closely with Moderna’s network of DS/DP manufacturing sites, microbiological laboratories, both internal and external (affiliated Contract Testing Organizations...


  • Basel, Schweiz Moderna Vollzeit

    **The Role**: The Associate Director of Risk Management, will partner closely with the Director of Risk Management and Metrics and the Director of Quality Systems to establish and oversee a Global Quality Risk Management system across Moderna that periodically identifies, evaluates, levels, and mitigates all the GxP related risks across the...


  • Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Moderna is seeking an AD/D External Quality Control based in Basal, Switzerland to oversee Quality Control (QC) testing including in-process, release, and stability in support of contract manufacturing and testing facilities and overall international operations for Moderna clinical and commercial products. This position reports to the Head...

  • Associate Director

    vor 2 Monaten


    Basel, Schweiz BeiGene, Ltd. Vollzeit

    Associate Director - Risk Based Quality Management Lead BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting...