Aktuelle Jobs im Zusammenhang mit Global External Quality Technical Team Lead - Baar - Biogen

  • General Manager, External Operations Europe

    Vor 4 Tagen

    Baar, Schweiz Biogen Vollzeit

    **Job Description** About the role** - Location_: Baar, CH as per local hybrid policy - Business travel_ :Ability to travel domestically and internationally as needed. You will oversee technical and business operations at designated external manufacturing sites, serving as the primary point of accountability for strategic and tactical activities and be...

  • Production Lead, External Manufacturing

    vor 1 Tag

    Baar, Schweiz Biogen Vollzeit

    **Job Description** About the role** Potentially under the coordination of a Virtual Plant Manager, you manage manufacturing operations for specific product(s) at one or more contract manufacturing organisations (CMOs). Responsibilities include commercial and/or clinical supply. Here you participate to one or several virtual plant teams. Manage a subset of...

  • Cmo Quality Lead

    vor 3 Wochen

    Baar, Schweiz Biogen Vollzeit

    Job Description** About This Role** In this role you will manage the Quality Activities with key/preferred manufacturing and testing partners (CMOs) for assigned products/projects by ensuring quality of product / process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process improvements. The...

  • Sr Production Lead, External Manufacturing

    Vor 7 Tagen

    Baar, Schweiz Biogen Vollzeit

    **Job Description** About this role** Under the coordination of a Virtual Plant Manager, you manage manufacturing operations for specific product(s) at one or more CMOs. Responsibilities include commercial and/or clinical supply. You participate to one or several virtual plant teams and manage a subset of product(s) with one or more CMOs. In this role you...

  • Cmo Quality Lead

    Vor 4 Tagen

    Baar, Schweiz Biogen Vollzeit

    **Job Description**: **About This Role** The main purpose of this job is to manage the Quality Activities with key/preferred manufacturing and testing partners (CMOs) for assigned products/projects by ensuring quality of product / process transfers, validations, issues investigations, tracking and resolution in a timely manner as well as process...

  • Production Lead, External Manufacturing

    Vor 3 Tagen

    Baar, Schweiz Biogen Vollzeit

    Job Description** About This Role **In this role you will work under the coordination of a Virtual Plant Manager and manage manufacturing operations for specific product(s) at one or more CMOs. **What You’ll Do**: - Responsibilities include commercial and/or clinical supply. - Participate to one or several virtual plant teams. Manages a subset of...

  • Quality Lead

    vor 1 Woche

    Baar, Schweiz Automated Engineering Services Vollzeit

    **Job Title: Quality Lead (CMO)** **The company** Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. Our clients are driven to continuously innovate and create meaningful value in all they do to help patients and families fully live their best lives. They value the uniqueness and diversity of employees...

  • Quality Cluster Lead

    vor 1 Woche

    Baar, Schweiz AstraZeneca Vollzeit

    **Quality Cluster Lead - West Europe & Southern Europe (WESE)** **Baar, Zug, Switzerland** **Salary & Benefits Competitive** **Introduction to role**: Are you ready to take the next step in your career and make a significant impact in the world of pharmaceuticals? We are seeking a dynamic and experienced Quality Cluster Lead to oversee the design,...

  • Global Patient Finding Lead

    Vor 3 Tagen

    Baar, Schweiz Biogen Vollzeit

    **Job Description** About the role** Location: Baar, Switzerland As Biogen portfolio continues to evolve including Rare Disease and beyond, this role leads and drives all Customer Excellence & Operations (CE&O) related patient finding capabilities and activities predominantly, in close collaboration with key cross functional stakeholders: - You define and...

  • Sr. Associate Ii, External Audit

    vor 1 Woche

    Baar, Schweiz Biogen Vollzeit

    **Job Description**: **About This Role** As a key contributor within the Corporate Quality organization, the Sr. Associate II, External Audit will be primarily responsible for performing external audits of Biogen vendors and suppliers. **What You’ll Do** - Coordinate, conduct, and provide follow-up for on-site audits and/or assessments of external...

  • Medical Evidence Quality Director

    vor 4 Wochen

    Baar, Schweiz AstraZeneca Vollzeit

    **Title - Medical Evidence Quality Director** (International)** **Location - Luton UK or Zug Switzerland.** **Salary - Competitive with attractive package** We are now recruiting an** Medical Evidence Quality Directo**r within **BioPharmaceuticals Medical (BPM).** Medical Affairs ensures the best patient outcomes by providing healthcare decision-makers...

  • Sr. Associate Ii, External Audit

    Vor 4 Tagen

    Baar, Schweiz Biogen Vollzeit

    **Job Description**: **About This Role** As a key contributor within the Corporate Quality organization, the Sr. Associate II, Corporate Quality will be primarily responsible for performing external audits of Biogen vendors and suppliers. **What You’ll Do** - Coordinate, conduct, and provide follow-up for on-site audits and/or assessments of external...

  • Global Corporate Affairs Lead

    vor 1 Woche

    Baar, Zug, Schweiz K-Recruiting Life Sciences Vollzeit

    About the Role">We are seeking a highly motivated Corporate Communications Manager to join our Rare Disease Corporate Affairs team.">The successful candidate will have a strong background in corporate communications and be able to provide strategic counsel to our affiliates and international regions.">You will be responsible for developing and implementing...

  • Digital Engineering Lead

    vor 3 Wochen

    Baar, Schweiz Biogen Vollzeit

    **Job Description**: Location: we are flexible for this role to be in our European locations ( for example Switzerland, Poland, Netherlands etc) **About the role**: As **Digital Engineering Lead** you will be responsible of the Ecosystem supporting Digital HCP engagement in the Global Digital CoE and its connection with rest of Biogen Ecosystem. You will...

  • Vice President, R&d Quality Assurance, Clinical

    vor 1 Woche

    Baar, Schweiz AstraZeneca Vollzeit

    Help push the boundaries of science to deliver life-changing medicines to patients! With science at its heart, this is where breakthroughs born in the lab become transformative medicine - for the world’s most complex diseases. Striving to understand the needs of diverse populations and act accordingly, we aim to transform healthcare to secure a future...

  • Global Study Manager

    vor 16 Stunden

    Baar, Zug, Schweiz Novocure Vollzeit

    We are seeking a Global Study Manager to lead our Phase III neuro-oncology study across multiple European countries.Responsibilities:Oversee site feasibility, selection, start-up, monitoring, and regulatory submissions for a multinational trialDevelop and manage budgets to ensure financial oversightCollaborate with CROs and vendors to ensure contracted...

  • General Manager, Fill Finish

    Vor 2 Tagen

    Baar, Schweiz Biogen Vollzeit

    **Job Description** About the role** **Location** Baar, Switzerland as per local HR hybrid policy **Travel**: Ability to travel domestically and internationally as needed. You will oversee technical and business operations at designated external manufacturing sites, serving as the primary point of accountability for strategic and tactical activities and...

  • Global Digital Engagement Capability Lead

    vor 1 Woche

    Baar, Schweiz Biogen Vollzeit

    **Job Description**: **About This Role** Specifically, this role will provide the following: - Identification, selection, implementation, roadmap, and maintenance of digital channel capabilities including best practices, templates, process flows, operational management, roles & responsibilities, playbooks, KPIs, data collection requirements and measurement...

  • Global Medical Lead Digital Health Solutions

    Vor 6 Tagen

    Baar, Schweiz Biogen Vollzeit

    **Job Description**: Neurological diseases are highly complex, devastating, and there are still significant challenges in how we understand and treat them. At Biogen Digital Health (BDH), we aspire to transform patients’ lives by making personalized & digital medicine in neuroscience a reality. Leveraging data-science and digital technologies, we drive...

  • Regcmc Small Molecules Team Lead

    vor 3 Wochen

    Baar, Schweiz Biogen Vollzeit

    **Job Description** About this role** **The role can be US based hybrid in Cambridge or RTP or Baar based in Switzerland** **What you'll do** - Accountable for line management and development of direct reports. - Managing RegCMC small molecule resources efficiently - budget tracking, ensure proper resources allocation (including external regulatory...

Global External Quality Technical Team Lead

vor 4 Wochen

Baar, Schweiz Biogen Vollzeit

Job Description**
About This Role**
In this function you will lead the Global External Quality Technical team in relation to daily activities.

You will provide support in Global External Quality (GEQ), Quality Systems, Program Management, CMO processes, and Release documentation activities for all commercial and clinical products (incl. external and internal Deviations, CAPAs and Change Controls, as well as performs transactions in the IT Quality systems that are under the Quality Oversight of GEQ organization.

The role also includes leading and supporting projects and process improvements impacting the GEQ processes as well as acts as BPO for GEQ owned processes (e.g. CMO Management).

In this role you will also provide support during product market launch activities (project management support, GCCs etc.) as well as lead/support projects from a systems perspective (e. g support in continuous improvement initiatives, global processes alignment, regulatory intelligence actions implementation for internal and external processes etc.).

Qualifications**
What You’ll Do**:

- Manage the Global External Quality Technical Team: Ensure training of the team and development of the team members.
- Support the Global External Quality organization as required in the management of Quality operations and Quality system activities including system follow up of deviations, CAPAs, and change controls (internal and external including Market launch activities), as well as the Authorization to Manufacture and product Transport approvals under the responsibility of Global External Quality.
- Lead projects, and global processes alignment (internal and external) as well as continuous improvement initiatives, regulatory intelligence actions monitoring and implementation.
- Perform resource allocation analysis for the Global External Quality organization on a monthly basis and communicate results and associates resource allocation actions (assignment of team support) to Global External Quality Leadership Team.
- Manages preparation and execution of Quality Management Reviews (global, Baar & CAM sites).
- Act as QA contact for IT Quality systems enhancements and business processes updates as needed.
**Who You Are**

**Required Skills**:

- Diploma/BS in Biochemistry, Microbiology, Chemical/Biochemical Engineering or other scientific topic
- Min. 5-7 years of experience in the pharmaceutical / biotechnology industries.
- Knowledge of cGMP requirements.
- Experience in Quality Systems.
**Preferred Skills**
- Experience in IT quality systems qualification, or project management (lean six sigma) is a plus

Additional Information**
Why Biogen?**
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.