Quality Assurance Manager Qc

**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 cGMP 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 cGMP/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 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