Head of Quality Assurance

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Job Description

About the role:

As Head of Quality Assurance (QA) at our Lessines site you will lead and develop the QA organization setting strategic direction and providing operational oversight for Quality Assurance activities supporting a large complex biopharmaceutical manufacturing operation.

How you will contribute:

Reporting to the Quality Site Head you will be accountable for the effectiveness of QA systems and processes ensuring that quality decisions and dispositions comply with cGMP and global regulatory requirements while enabling safe reliable and timely product supply. Responsibilities include:

• Lead the QA organization of >90 employees providing quality oversightacrossPurification Aseptic Filling Packaging Warehousing and Shipping including site sterility assurance governance and batch disposition for marketed and clinical products.
• Partner with Manufacturing Engineering Supply Chain and QC to embed quality across operations; provide strong visible Quality leadership and independent shop-floor oversight to ensure robust GMP compliance across 24/7 operations and enable timely issue resolution in collaboration with cross-functional partners.
• Champion compliance and be accountable for implementation by influencing cross-functional partners to adopt and follow applicable regulatory requirements Quality Systems and Global and Local procedures; monitor adherence address gaps and escalate risks as needed.
• Ensure the QA organization provides end-to-end oversight by applying risk-based decision-making to review/approve deviations investigations CAPAs and change controls ensuring timely implementation of health authority/regulatory requirements.
• Ensure timely compliant batch disposition and product release to support reliable supply for marketed and clinical products worldwide.
• Set the QA strategy priorities and performance standards aligned with site and business strategy to ensure sustained cGMP compliance and inspection readiness. Ensure robust QA resource planning and budget stewardship including organizational design succession planning and capability building.
• Make independent quality decisions for the site balancing compliance supply continuity and risk in a transparent data-driven manner.
• Champion innovation and transformation by leveraging external networks and digital solutions to drive continuous improvement simplify processes and strengthen quality performance across the site.
• Serve as the sites primary QA interface to health authorities and global stakeholders supporting the site inspection readiness program and representing the site/ Operating Unit in Global Quality initiatives and cross-functional projects.
• Provide strategic directionas a member of the Site Quality Leadership Team.

What you bring to Takeda:

• Masters degree in pharmaceutical chemical biological or technical sciences.
• 10 years of experience in a GxP-regulated pharmaceutical or biotech environment.
• Proven people leadership experience in complex highly regulated (GxP) environments.
• Strong knowledge of cGMP FDA CFR EU GMP and global regulatory requirements for biological products with proven GMP inspection experience. Exposure to FDA and AFMPS inspections and agency interactions is a plus.
• A proven ability to foster a culture of accountability and collaboration driven by operational excellence and digital transformation.
• Strong Transformational Agility: ability to anticipate change lead through ambiguity and lead others through transformation.
• Strong risk-based decision-making with excellent communication influencing and relationship-building skills with internal and external stakeholders across all levels.
• Expertise in microbiology contamination control and aseptic processes/practices is a plus.
• Fluent in English and French (written and spoken).

What Takeda can offer 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 70/20/10 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 sustainable and eco-friendly transportation and on-site charging stations for electric vehicles.
• Additional Perks: Meal vouchers eco-cheques a flex plan a 13th-month salary and pension support.

More About Us:

Takeda is a global leader in rare diseases and ranks among the top three manufacturers for plasma-derived products.

Our production site in Lessines with over 50 years of expertise represents biotechnological excellence. The site specializes in the purification of immunoglobulins plasma-derived therapies and the filling and packaging of life-saving treatments for blood disorders.

Every year we meet the needs of more than 250000 patients worldwide. As Takedas third-largest production site we play a key role in global operations proudly distributing several million vials annually to over 80 countries.

Certified as a Great Place to Work in many countries Takeda offers stimulating careers fosters innovation and encourages excellence. We believe in an inclusive and collaborative work environment where every talent contributes to our mission: Better Health and a Brighter Future for people around the world.

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