Manager External Supplier QA (all genders)Singen (Hohentwiel), Baden-Württemberg
Vaccines prevent 2 to 3 million deaths each year and have transformed global public health. For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda's global vaccine business is applying innovation to tackle some of the world's most challenging infectious diseases, such as dengue, COVID-19, Zika and norovirus. Takeda’s team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world's most pressing public health needs.
Are you looking for a patient-oriented, innovation-driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a
Manager External Supplier QA (all genders)
Your main responsibilities:
Supports cGMP activities for products in late phase clinical programs, launch and commercial manufacturing, conducted on behalf of the VBU including manufacturing, testing, packaging and shipment of all materials, to ensure compliance with Takeda QMS, cGMP and global regulatory requirements.
Works as part of the Dengue QA Team with focus in Quality Assurance systems/process execution related to product specific late phase clinical programs and commercial activities, such as, but not limited to, batch disposition, document & data control, change control, investigations, inspection preparedness, life cycle management etc.
Assures consistency in achieving product quality and compliance across multiple Contract Manufacturing Organizations (CMO)s and global markets.
Responsible for day-to-day interactions with contract facilities like: CMOs, CTLs, and/or CSP
- Conduct and support investigations into Good Manufacturing Practice related issues or problems associated with audits, batch records and complaints.
- Review and approve manufacturing and testing deviations and investigations into out-of-specification results.
- Supports timely execution and completeness of change management at interface with CMOs and of internal Takeda change management.
- Review and approve batch production records and test records.
- Review and approve validation documentations
- Review and approve shipment or material transfer request
- Perform interim batch assessment in preparation for QP batch disposition.
To work with external manufacturing, project management, supply chain, technical operation, CMOs and QA to ensure timely closure of excursions to include deviations, CAPA, change controls and interim batch assessment as applicable.
Bachelor’s Degree or higher in Chemistry, Microbiology, or Life Sciences, or equivalent scientific discipline.
Minimum of 3 years of experience in quality or regulatory compliance within the pharmaceuticals, biologics, or other related industry(ies).
Good Manufacturing Practice experience, or experience in other regulated industry.
Excellent communication skills both oral and written in German and English.
Experience with supporting product inspections from global Regulatory Authorities.
Effectively represent Quality Assurance, both internally and externally.
Experience in routine office software packages and specialized software applications as appropriate.
Exhibit and promote Takeda Core Competencies.
In this position you will report to the Lead, External Supplier QA.
Temporary contract until: 31. March 2025
·Attractive and competitive salary
·Open-minded and modern working environment
·30 vacation days
·Company pension plan
·Further education and training
·Travel allowance for public transport
·Subsidized sports programs
·Supplementary nursing care insurance
·Employee Stock Purchase Plan
·Employee Referral Program
·Deferred compensation as desired
·Global Wellbeing Program
·Employee Recognition Program
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
In Singen around 1,000 employees specialize in the production of liquid, semi-solid and freeze-dried pharmaceuticals. In November 2019, we inaugurated our first dengue vaccine factory worldwide here. Singen is located at the beautiful Lake Constance in Baden-Württemberg.
How we will support you:
Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law. If you are living with disabilities, chronic illness or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.
Time TypeFull time
What makes a successful team member within Vaccines at Takeda?
Vaccines represent a new dimension of global impact — successful leadership at Takeda can be encompassed in these four pillars:
Demonstrating strategic enterprise thinking, finding innovative ways to serve patients and build trust, reputation and business
Creating the environment that inspires and enables people to move the organization forward
Focusing on the few priorities and delivers superior results
Elevating the capabilities of the organization for now and the future
Working at Takeda
InclusionHere, you will feel welcomed, respected, and valued as a vital contributor to our global team.
CollaborationA strong, borderless team, we strive together towards our priorities and inspiring mission.
InnovationBold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceRecognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
Work-LifeOur people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
EmpowermentThrough trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Create an exceptional people experience.
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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