Compliance Specialist Pharma (all genders)Singen (Hohentwiel), Baden-Württemberg
At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.
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
Compliance Specialist Pharma (all genders)
In this role, you will support our international Compliance Department, significantly contributing to the adherence and future assurance of GMP compliance at the Singen site. Moreover, you will actively engage various projects, e.g. in Dengue Vaccine projects, providing you with the opportunity to participate in groundbreaking vaccine development initiatives and make a substantial contribution to global health.
Your main responsibilities:
- Coordinate local guideline compliance / gap assessment process, including maintaining process SOP in alignment with the latest regulatory guidance, industry requirements and Takeda's global SOPs.
- Track and manage corrective and preventive actions (CAPAs) resulting from gap assessments.
- Management and maintenance of SISR (Site Inspection Success Register) for Singen (quarterly updating)..
- Perform gap assessments for inspection and audit findings at other Takeda sites.
- Assist in the management, coordination, and performance of Health Authority Inspections, Customer Audits, and Internal Quality Audits.
- Support activities related to inspection readiness, such as IRE (Inspection Readiness Exercise) and walkthroughs.
- Contribute to the self-inspection process by performing self-inspections as a Lead Auditor, representing process owners, and tracking and closing corrective measures.
- Maintenance of Compliance Documentation e.g. Site Master File, Quality Manual as well as preparing and review of SOPs relevant for the Compliance Department.
- University degree in natural sciences or a related field.
- You have gained first experience in the pharmaceutical industry including Quality unit experience.
- With a broad overview of all relevant national and international pharmaceutical directives, guidelines and knowledge of their requirements you can support us in various projects at the Singen site.
- You are familiar with the use of MS Office tools and can demonstrate proficiency with electronic quality management systems.
- Effective communication and consistently delivering on commitments.
- Proficiency in both English and German is essential, with a particular emphasis on written German skills.
In this position you will report to the Inspection Management Quality Compliance.
Attractive and competitive salaryaccording to collective bargaining agreement
Open-minded and modern working environment
Hybrid working model
30 vacation days
Company pension plan
Further education and training
Subsidized sports programs
Supplementary nursing care insurance
Employee Stock Purchase Plan
Employee Referral Program
Deferred compensation as desired
Future amount (addition only for tariff positions)
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 Singenaround 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. Singenis 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
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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