About the role:
An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 670 employees) for a Quality Manager, within the Quality Assurance Department.
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Unit team within a world-class Biotech manufacturing environment.
The scope of the role is to manage the day-to-day and the medium to long-term operations related to purification manufacturing activities of biologic products, ensuring compliance with the license, regulations as well as cGMP Regulations. He/she will manage and develop his/her team in order to contribute to their career growth. The job holder is expected to act as Qualified Person Delegate.
How you will contribute:
• Ensures the day-to-day quality oversight of the manufacturing operations related to his/her scope of responsibility
• Responsible for the effective management of the quality systems operating in his/her scope, including deviations (events), CAPA, batch review, change control, documentation, etc. Effectiveness is demonstrated through KPIs and management reviews in line with Site Guidance.
• Provides direction in the event of manufacturing incidents that may potentially affect quality or compliance
• Ensures that deviations and complaints are investigated, reports are available
• Ensures that escalation mechanisms as defined in site regulations are being adhered to Supervises ongoing daily departmental activities for areas of direct responsibility, and when required assist other areas in the successful performance of these activities.
• Ensures a constant alignment with his/her QA peers to provide a consistent quality support to the entire Neuchâtel site and beyond
• Cultivates a smooth and collaborative partnership with his/her local and global business partners (i.e., Manufacturing, Supply Chain, Laboratories)
• Contributes that responses to Regulatory and Compliance requests (RA questions and submissions, Observations, Compliance gaps, Audits, etc.) related to his/her group are provided in a timely manner and with appropriate level of quality
• Represents area of responsibility internally and externally
• Acts as QP delegate and perform all related activities including batch disposition
• Manages a team of about 10 people and conduct Compensation reviews, Performance Review Conversations, Setting of Objectives, Development Plans
• Manages the resources to ensure medium to long-term departmental objectives and time scales are achieved
• Owns personal accountability for all EHS Aspects, ensuring his/her team is operating in a safe workplace
• Drives continuous improvement and Lean Culture
What you bring to Takeda :
• University degree in Life Science
• Minimum 5-10 years of experience in sterile and/or biological products pharmaceutical industry having held different positions in operations
• People management
• Qualified Person/delegate experience is a plus
• Fluent English (C1) and French (min B1) is a must
Working Environment:
• Full time job, daily working hours Monday-Friday
What Takeda can offer you:
• Attractive salaries
• Full accident cover
• Participation in health insurance premiums
• Advantageous retirement plans
• Subsidized meal
• Financial participation in the sports practices of its employees
• Transportation: support in local public transport, free parking, carpooling program
• Takeda Neuchâtel offers to its employees an attractive framework and working conditions. The well-being, safety, development and career development of its employees are at the heart of our vision and of our Human Resources, Health, Environment and Safety policies.
• Takeda Neuchâtel is an employer committed to its employees and future generations.
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 religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status.
Locations
CHE - Neuchatel
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time