Zurich, Switzerland
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Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
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Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2020.
At Takeda, your determination and energy, combined with our cutting-edge technology and global R&D, offers families and communities hope for Better Health and a Brighter Future.
Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.
At Takeda, there is an unwavering commitment to putting patients first, and to creating a workplace that is underpinned by empowerment and focused on diversity, collaboration and steadfast values.
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Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
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Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as the QA Head for Cell Therapy in our Zurich office.
Here, you will be a vital contributor to our inspiring, bold mission.
Lead the Quality activities related to commercial launch of Takeda’s new Cell Therapy and act as the main contact between the Local Operating Companies and the manufacturing sites;
Work closely and collaboratively with broader cross-functional regenerative medicines team ensuring Local Operating Companies & CoEs are trained and prepared to launch and commercialize Cell Therapy;
Ensure Cell Therapy documents (SOPs, Quality Agreements, etc) and systems are up-to-date and aligned with Takeda QMS as well as Cell Therapy requirements;
Coordinate global change controls of Cell Therapy and follow up on action plans;
Support the manufacturing sites to ensure the efficient and effective resolution of critical product quality/compliance issues. Accountable to provide leadership to drive issues resolutions timely;
Support cell therapy manufacturing sites to ensure the local site Quality Systems are aligned with Takeda QMS and Cell Therapy requirements;
Participate in Regulatory strategy development, revising and/or approving documents, such as supplements/variations, renewals, CMC maintenance reports, annual reports and assure consistency of regulatory filings for assigned product(s);
Support product and site inspections& audits from Regulatory Authorities & other organizations.
REQUIRED QUALIFICATIONS
Knowledge and experience working with EU ATMP (Advanced therapy medicinal products) regulatory submissions and regulatory agency expectations and inspections in this field.
Proven leadership skills, involving several levels of an organization to successfully meet the objectives
Experience working with complex organizational and ability to work across functions and with all levels of the organization where the incumbent may not have direct authority
Demonstrated excellence in developing & managing effective teams
Graduate degree in either a management or technical discipline preferred
Minimum of 10 years experience in the Pharmaceutical industry with significant experience in biologics, vaccines, and/or biopharmaceuticals
Minimum of 5 years experience in QA/QC with increasing responsibility
Demonstrated knowledge of GMPs, compliance issues, inspectional trends, industry quality assurance practices and systems, and personal management skills
Job requires frequent travel
WHAT TAKEDA CAN OFFER YOU
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering Our People to Shine
Discover more at takedajobs.com
Zurich, Switzerland
Employee
Regular
Full time
Job ID R0023785
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By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that I agree with Takeda’s Privacy Notice, Privacy Policy and Terms of Use.
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as the QA Head for Cell Therapy in our Zurich office.
Here, you will be a vital contributor to our inspiring, bold mission.
Lead the Quality activities related to commercial launch of Takeda’s new Cell Therapy and act as the main contact between the Local Operating Companies and the manufacturing sites;
Work closely and collaboratively with broader cross-functional regenerative medicines team ensuring Local Operating Companies & CoEs are trained and prepared to launch and commercialize Cell Therapy;
Ensure Cell Therapy documents (SOPs, Quality Agreements, etc) and systems are up-to-date and aligned with Takeda QMS as well as Cell Therapy requirements;
Coordinate global change controls of Cell Therapy and follow up on action plans;
Support the manufacturing sites to ensure the efficient and effective resolution of critical product quality/compliance issues. Accountable to provide leadership to drive issues resolutions timely;
Support cell therapy manufacturing sites to ensure the local site Quality Systems are aligned with Takeda QMS and Cell Therapy requirements;
Participate in Regulatory strategy development, revising and/or approving documents, such as supplements/variations, renewals, CMC maintenance reports, annual reports and assure consistency of regulatory filings for assigned product(s);
Support product and site inspections& audits from Regulatory Authorities & other organizations.
REQUIRED QUALIFICATIONS
Knowledge and experience working with EU ATMP (Advanced therapy medicinal products) regulatory submissions and regulatory agency expectations and inspections in this field.
Proven leadership skills, involving several levels of an organization to successfully meet the objectives
Experience working with complex organizational and ability to work across functions and with all levels of the organization where the incumbent may not have direct authority
Demonstrated excellence in developing & managing effective teams
Graduate degree in either a management or technical discipline preferred
Minimum of 10 years experience in the Pharmaceutical industry with significant experience in biologics, vaccines, and/or biopharmaceuticals
Minimum of 5 years experience in QA/QC with increasing responsibility
Demonstrated knowledge of GMPs, compliance issues, inspectional trends, industry quality assurance practices and systems, and personal management skills
Job requires frequent travel
WHAT TAKEDA CAN OFFER YOU
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering Our People to Shine
Discover more at takedajobs.com
Zurich, Switzerland
Employee
Regular
Full time
Job ID R0023785