IT Systems Quality Manager

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About The Role

Job Description

In this role, you will actively participate to the digital transformation of the Takeda Lessines’ facility. You will manage the Laboratory management systems, ensure the quality partnership with our digital, robotics & innovation team and actively participate to the development of the digital mindset in GxP environment.

You will lead a small team of specialists in Laboratory Management Systems, IT/Computerized Systems regulations, and digital tools (Artificial intelligence (AI), Machine learning (ML), Virtual Reality (VR), Augmented reality (AR), Robotic process automation (RPA), cobots, etc.

How You Will Contribute

• Manage the execution and maintenance of Laboratory Management Systems (LIMS)
• Collaborate with business partners including IT, Quality SMEs, Business System Owners and digital team for giving guidance on computerized systems/applications, meaning these are developed in compliance with the applicable company procedures, quality & regulatory requirements and applicable industry computerized systems standards
• Identify, promote, build business cases and implement or support implementation of solutions to participate to the digital transformation of Quality processes
• facilitate the communication/understanding between system owners and quality representatives
• be an active contributor to solve issues, making a lasting impact by transforming operations
• Build knowledge and understanding of data’s process flow and digital tools using these data’s
• Take part in the quality workforce transformation by developing knowledge of data preparation/manipulation, visualization and reporting tools
• Benchmark and share best practices with other sites and the pharmaceutical industry
• Responsible for the coaching, training, and development of the IT Systems Quality Team.
  

What You Bring To Takeda

• Bachelor’s in Sciences or Computer or an equivalent degree.
• A solid understanding of Data Integrity & Computerized System current regulations (e.g., 21 CFR Part 11, EudraLex Volume 4 Annex 11, FDA Data Integrity and Compliance Guidance, MHRA ‘GXP’ Data Integrity Guidance, PIC/S Data Management and Integrity Guidance, GAMP 5 life cycle approach, ICH, …)
• A thorough understanding of pharmaceutical quality management systems including validation and regulations ia current GMPs & GDDPs. Experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections preferred
• Understanding of data manipulation and visualization tools
• understanding of how technology efforts are tied to the achievement of business goals
• ability to lead or participate to quality risk assessments performed in the context of creation of business cases linked to digital solutions
• Practical knowledge of working in a pharmaceutical company Ideally minimum of 5 years of experience within pharma industry
• Organizational and ability to innovate, lead change, deliver strong results and build the confidence as well as trust of stakeholders.
• Possess effective leadership and self-management
• Ability to effectively communicate and influence others across all levels of the organization
• Ability to write and speak in the English language.
• Excellent oral and written communications skills, business acumen with analytical, critical thinking and problem-solving skills.
  

What Takeda Can Offer You

• Informal working atmosphere with attention to improve your work-life balance
• Flexible ways of working
• Competitive salary package for a Manager 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