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Head of Quality Compliance and Systems

vor 3 Monaten


Neuenburg, Neuenburg, Schweiz Takeda Vollzeit

Description

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:

"Empowering our people to shine":

Locations

CHE - Neuchatel

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time