Quality Validation Lead

工作内容

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About The Role

Job Description

You are part of the Quality Systems team at the Takeda Lessines site and lead a team of Quality Validation Engineers.

As Quality Validation lead, you guarantee the quality oversight of the site’s qualification, validation and revalidation activities.

You will lead a team of +- 7 people

How You Will Contribute

• Quality oversight and active quality support for validation and revalidation activities at the site
• Manage through the site Quality Validation Engineers the coordination of the Quality Validation activities
• Support definition of site validation strategy using risk-based approach and associated with varied projects covering facilities, utilities, equipment, process, product, cleaning, material, shipping, IT and computerized systems.
• Ensure the status of site validation system is established and maintained in accordance with intern local and global procedures, regulatory requirements and guidance/standards and in collaboration with the validation teams.
• Ensure compliance with applicable provisions of the Takeda Quality Management System, the regulations and standards applicable to the operations. Interface with regulators during inspections.
• Provide support, expertise and guidance in interpreting policies, regulatory regulations, and internal regulations to assure compliance.
• Support site digital transformation and continuous improvement for topics related to your part of the business. Identify, encourage and drive improvement opportunities.
• Support for the ongoing adaptation and further development of the validation system with regard to quality requirements
• Communicate effectively at all levels within Quality, as well as cross functionally with departments and sites.
• Support risk analysis activities. Demonstrate proficiency in applying risk management tools and practices.
• Responsible for the coaching, training, and development of the Quality Validation team.
• Identify the need for external contributors with respect of the project milestones and budget constraints. You assure their onboarding, training and coaching.
• Ensure an adequate Training and Qualification program is in place
  

What You Bring To Takeda

• Bachelor’s or Master’s degree in engineering, chemistry, biology or related discipline
• Minimum 5 years of experience in Quality or related field in the pharmaceutical industry
• Minimum 5 years of leadership experience, developing people and strength in managing projects and initiatives
• A thorough understanding of pharmaceutical quality management systems and regulations including current GMPs & GDDPs.
• Experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections preferred
• Fluency in written and spoken French and English
• Personal accountability for results and integrity. Critical thinking, analytical, deal with ambiguity and problem-solving skills.
• Demonstrated ability to work autonomously and to take decisions
• Organizational and ability to innovate, lead change, deliver strong results and build the confidence as well as trust of stakeholders.
• Experience with Continuous Improvement initiatives
• Ability to lead multidisciplinary and multi-site projects
• Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
• Strong organizational skills
  

What Takeda Has To Offer

• Family work environment
• Informal working atmosphere with attention to improve your work-life balance
• Flexible ways of working
• Competitive salary package for a Lead role
• Full time permanent contract
• Room for horizontal and vertical growth within the company
• Joining a company with strong results every year and with massive investments from the Corporate to develop further the site.
• Opportunity to interact with numerous colleagues around the globe, multinational collaboration within the Global Quality Business Unit.
  

More About Us

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.

Empowering our people to shine

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics, marital or other status. At Takeda, we embrace diversity as a whole.

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Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time