Recruitment Fraud Alert
Takeda has received reports that there are instances of identity thieves posing as Takeda employees in an attempt to steal personal information from job seekers. In these cases, identity thieves visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and personal identification numbers. If you receive unexpected offers of employment from people claiming to work for Takeda, we suggest you do not correspond with them, do not click any hyperlinks and do not open any attachments.
At Takeda, we will never ask for personal financial information during any step of the interview nor do we charge job seekers fees as part of the recruitment process. Takeda’s recruiting correspondence will be sent by a recruiting representative with an @takeda.com email address – not @gmail.com, @yahoo.com, @hotmail.com or any other email domain service.
If you believe you have been contacted by an unauthorized person, please contact your local law enforcement agency immediately.
Quality Systems Manager
Primary duties :
- ensure that the Quality System processes are effectively established, maintained and improved
- manage through the site Systems Execution Leads the coordination of the Quality Systems activities including the Deviation, Change Control, Documentation, GMP training and Laboratory Information Management processes and systems.
- Manage the execution and maintenance of :
- the Deviation Process. Ensures that deviations, associated investigations and action plans are appropriately and timely performed and documented.
- the Change Control Process. Ensures Changes are appropriately documented and timely implemented.
- the Documentation Process.
- The GMP training quality oversight
- Laboratory Information Management System (LIMS)
- administration access role of analytical equipment’s.
- Responsible for ensuring compliance with all applicable provisions of the Takeda Quality Management System, the regulations and standards applicable to the operations.
- Conduct gap analyses, implement Quality Management System procedures in departments and manage compliance.
- Understand and assure conformance to applicable Takeda standards and regulations. Interface with regulators during inspections.
- Define and manage action plans to ensure satisfactory quality metrics
- Establish goals for the Quality Systems department in alignment with the global and site strategy, and take action as needed to ensure timely delivery of goals.
- Responsible for the coaching, training, and development of the Quality Systems team.
- Ensure an adequate Training and Qualification program is in place
Education and Experience Requirements
- Bachelor’s – Master’s degree in engineering, chemistry, biology or related discipline
- At least 5 years’ experience in Quality or related field in the pharmaceutical industry.
- At least 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.
Key Skills, Abilities, and Competencies
- Fluent 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
- PC skills and be competent in Word, Excel, PowerPoint and SharePoint