QRC ManagerApply Now Email Me Job ID SR0031906 Date posted 01/15/2019 Location:Neuchâtel, Switzerland
An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 650 employees) for a Quality & Regulatory Compliance Manager.
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. This is a 7 months Takeda's contract.
The jobholder ensures the compliance of the NE Manufacturing site with global regulations as well as with licenses during routine manufacturing and projects. Expectations of regulators are met and business continuity will be supported. The jobholder is the site point of contact and coordinator for communication with authorities following requests to local RA.
The jobholder manages Quality Systems activities for the NE site.
The role provides leadership to a quality professional team supporting talent growth as well as linking the people process with a compliance business strategy for the site.
The jobholder is a member of the senior Quality Team of the Neuchatel Site and supports other quality functions and departments as required
Essential duties and responsibilities
- Manage and develop a team of Quality professionals to assure compliance excellenceat the site, ensure professional growth and career progression and contributes to a Workforce Plan for the site QA Organization.
- Lead the activities related to the establishment and the functioning of the quality management system at the site
- Lead a permanent Inspection ready status on site preparing regulatory audits, paper based inspections, internal inspections, and ensure the corrective actions bring benefit to the site. Manage communication process to the authorities and global functions, especially when reporting on major changes/issues as well as utilizing the escalation process established by Takeda.
- Ensure all regulatory filings are compliant with our Processes, Product Specifications and Facility set up and ensure integration of global regulatory expectations into site Q Systems, in particular for emerging markets
- Ensure a Change Control system is established to support the site operations.
- Ensure that all Quality Systems are established and executed on Site. Effectiveness is demonstrated through KPIs and management reviews are being conducted in line with Takeda Guidance
- Comply with all EHS requirements.
Education & Experience
- University degree in Life Science
- Minimum 8 years of experience in the pharmaceutical industry including Quality Systems.
- Fluent English and French
- Thorough knowledge of global cGMPs
- Experience hosting and preparing for inspections
- Experience with Continuous Improvement initiatives
- Has people management experience and can lead a team to deliver results
- Full time job, daily working hours Monday-Friday
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