Head of Quality Compliance and Systems
vor 1 Monat
At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.
**Job ID** R0121047**Date posted** 04/22/2024**Location** Neuchâtel, Canton of Neuchâtel**About the role**
***:
**A unique opportunity is now available for the Head of Quality Compliance & Systems position located at our biological production site in Neuchâtel.**:
**You will have the overall responsibility to oversee that the processes are effectively established and maintained. Additionally, you'll play a pivotal role in enhancing the overall site capability.**:
**Your expertise will be instrumental in enhancing site capabilities, driving diversity, and fostering an inclusive work environment.**:
**How you will contribute**
***:
Regulatory Inspection Process:
- You will ensure Compliance with Takeda Quality Management System, regulations and standards, manage Compliance Risk Assessments and represnet your department during regulatory inspections.
- Ensure the oversite of Quality Systems Pocesses.
- You will lead a permanent Inspection ready status and Manage communication and escalation to authorities and global functions.
- Responsible for maintaining site licenses, renewals and paper inspections and lead the program of Self-Inspection.
- Be the representative for Halal certification.
Quality Governance:
- Report on quality metrics and KPIs.
- Conduct Quality Council.
- You will monitor complaints responsesaintain Risk management and Risk Register.
Leadership & Partnership:
- Continuously fosters the growth and development of team members.
- Cultivates robust partnerships with essential business stakeholders
- Act as QP delegate/RP for the site.
**What you bring to Takeda**
***:
- A Master’s (1 year) degree in pharmacy (or higher).
- 10 years of experience in Quality or related fields in the pharmaceutical industry.
- At least 5 years of leadership experience, developing people and strength in managing projects and initiatives.
- Experience with Continuous Improvement initiatives and operations (specifically deviations and Change control).
- A thorough understanding of pharmaceutical quality management systems relating to commercial manufacturing, including GMPs.
- Experience in interacting with health authorities including hosting/direct involvement with agency inspections.
- Fluent English and French.
- Proficient in Microsoft Word, PowerPoint, Excel, Trackwise, Veeva and digitalization of metrics.
**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 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._
**Locations**: CHE - Neuchatel
- ** Worker Type**: Employee
- ** Worker Sub-Type**: Regular
- ** Time Type**: Full time
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