Quality Systems Senior Specialist (Change Control)

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Job Description
About the Role:
As a Quality Systems Senior Specialist based at our Lessines site, you will play a critical role in ensuring the effective implementation, maintenance, and continuous improvement of Takeda's global Quality Management System (QMS) - with a primary focus on Change Control Management.
You will act as a key interface between global standards and local execution, translating compliance requirements into clear, efficient processes that enable business continuity and regulatory readiness. You will also champion a culture of quality by training, supporting, and engaging site users.
This is a hybrid role, requiring a balance of strategic insight and operational execution - ideal for someone who thrives in a complex, cross-functional, and continuously evolving environment.
How you will contribute:

• Lead and own the Change Control process at site level, in alignment with global QMS requirements and tools (e.g., Veeva, TrackWise)
• Conduct gap assessments between global and local SOPs; ensure local procedures and training materials are current and aligned
• Develop and maintain local documentation, including SOPs, work instructions, and training modules
• Act as Local Business Administrator for the QMS tool, ensuring proper system setup, user access, and technical oversight
• Coordinate Interfacility Change Requests by consolidating site impact assessments and maintaining communication with global stakeholders
• Deliver training sessions (initial and refreshers), and provide coaching to end users to ensure effective system adoption and compliance
• Support audits and inspections, coaching auditees and preparing records that reflect QMS compliance
• Monitor QMS performance metrics such as overdue records, lead time, and cycle time; investigate root causes and propose corrective actions
• Generate and present reports and dashboards for local and global Quality stakeholders
• Serve as data provider for Product Quality Review (PQR) and other governance processes
• Identify, lead, and implement continuous improvement initiatives, including simplification of QMS processes at Lessines
• Represent Lessines in global QMS forums, sharing best practices and driving cross-site alignment
• Facilitate Communities of Practice (CoP) at the site and participate in inter-site networks
• Organize and lead local governance boards related to QMS topics
• Promote a strong quality culture and foster user ownership through communication, training, and support
• Escalate systemic challenges to the Quality Systems Manager and contribute to process remediation and evolution

What you bring to Takeda:

• Bachelor's or Master's degree in a technical, chemical, biological or pharmaceutical discipline
• Minimum 3 years of experience in Quality Systems, Quality Operations, or related function in a regulated environment (pharma or biotech preferred)
• Strong analytical and problem-solving skills; ability to interpret data, identify trends, and recommend actions
• Solid understanding of quality system principles and Good Documentation and Data Practices (GDDP)
• Experience working with electronic QMS tools (e.g., Veeva, TrackWise) is a strong asset
• Excellent communication and facilitation skills; comfortable presenting to diverse audiences
• Proven ability to develop, deliver, and adapt training content
• Ability to manage multiple priorities, stakeholders, and deadlines in a matrix environment
• Fluent in English (minimum B1 level)
• Proficient with Microsoft Office tools (Excel, PowerPoint, Word)
• Demonstrated ability to lead improvement projects and influence cross-functional teams

What Takeda can offer to you:
We want our employees to succeed in everything they do - at work, at home, and in the community. This is why we offer world-class benefits and access to resources that can support people.
Our sector and the needs of our patients are constantly changing, which is why we emphasize continuous training. We actively support and invest in the development of our employees through a 50/40/10 training model.
We offer a comprehensive benefits package, prioritizing wellbeing, career growth, and work-life balance:

• Generous Time Off: 20 days of paid vacation in accordance with Belgian legislation and 12 Working Time Recovery days with additional days granted based on seniority and age.
• Health & Wellbeing: Comprehensive health and hospitalization insurance, annual check-ups starting at age 45, and support for preventive healthcare.
• Family Support: Paid leave for maternity, paternity, and adoption, along with dedicated spaces for nursing mothers.
• Career Development: Access to a Learning Catalog, language courses, and opportunities for internal and international mobility.
• Transportation & Eco-Benefits: Contributions for public transport, incentives for cycling, and on-site charging stations for electric vehicles.
• Additional Perks: Meal vouchers, eco-cheques, a flex plan, a 13th-month salary, and pension support.

Important Considerations:
At Takeda, our patients rely on us to create quality products, and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, hot environment and load manual handling.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals and biologicals products that may require specific protection (respiratory, skin, etc.)

More About Us:
The Takeda Lessines manufacturing site plays a vital role in the production of Takeda's plasma-based therapies. With over 75 years of pioneering legacy, Takeda is a global leader in rare diseases and ranks in the top three for plasma-derived products. Our Lessines manufacturing site is a state-of-the-art biotechnology production facility with over 50 years of experience, specializing in immunoglobulin purification, plasma-derived therapies, and packaging for treatments targeting blood disorders. Serving more than 250,000 patients worldwide, we are dedicated to delivering high-quality therapies that make a significant impact. As Takeda's third-largest global production site, Lessines plays a pivotal role in our international operations, producing and distributing million vials annually to more than 80 countries.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
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Locations
BEL - Lessines
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time