Quality Assurance Manager Qc

vor 1 Woche

Basel, Basel-Stadt, Schweiz Takeda Pharmaceutical Vollzeit

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 daytoday 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 longterm 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 510 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 wellbeing, 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

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