May 31, 2024

Takeda Pharmaceutical

Neuchâtel

OTHER

Quality Assurance Manager QC & Raw Material

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Job Description

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 Quality Control and Raw Material activities related to sterile biologic products manufacturing, ensuring compliance with the license, regulations as well as c GMP Regulations. He/she will manage and develop his/her team 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 Quality Control activities and Raw Material management related to his/her scope of responsibility
Ensures raw material release and manages specifications
Collaborates with suppliers to address quality issues and implement corrective action plans
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.
Supports the Quality on the Shop Floor culture
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., Laboratories, Supply Chain, Manufacturing)
Contributes to site strategic projects and objectives
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 partmental 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 with extensive experience in Quality Control operations
At least 5 years of experience in people management
Good knowledges of method validation/verification and equipment/software validation requirements
Excellent knowledge of c GMP/GLP
Experience of aseptic filling under isolator and of visual inspection is highly appreciated
Qualified Person/delegate experience is a plus
Fluent English (C1) and French (min B2) is a must

What Takeda offers you:

Competitive salaries
Full accident coverage
Participation in health insurance premiums
Advantageous pension plans
Subsidised meals
Financial participation in employee sports activities
Transport: support for local public transport passes, free parking, car sharing programme.
Takeda Neuchâtel offers its employees an attractive working environment and conditions. The well-being, safety, development and career advancement of its employees are at the heart of our vision and our Human Resources, Health, Environment and Safety policies
Takeda Neuchâtel is an employer committed to its employees and to future generations.

Learn more about Takeda Neuchâtel :

With over 700 employees, Takeda Neuchâtel is one of the ten largest employers in the Canton of Neuchâtel and one of the leading biopharmaceutical production sites in Switzerland. Operating 24 hours a day, 7 days a week, the site employs a wide range of professionals trained in biotechnologies and their application in industrial production.

With more than twenty nationalities, Takeda Neuchâtel offers an international, diverse and innovative working environment within a company that is firmly rooted and committed to its local ecosystem.

Takeda Neuchâtel is certified as a training company by the Swiss State Secretariat for Economic Affairs. We train young apprentices in various fields such as laboratory quality control, logistics, IT and biopharmaceutical production.

"Empowering our people to shine:

Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and job applicants without regard to skin colour, religion, gender, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law.