About the job QA RA Director
About our Client
Our client is a Life Sciences company with a great history of developing products/equipments to support industries within the Biotech and Consumer Goods sector. They believe in constantly improving their processes to come up with cutting edge technologies to further enhance their products. Quality and safety play a big part in their organisation and as such, they are looking for a QA Director to support their growth plans.
Reporting to a VP/Head
of QA, the role involves strong leadership and stakeholder management in
addition to overseeing all QA functions.
Additional Responsibilities Include:
· Develop and maintain the Quality Management System in accordance with ISO standards.
· Manage and groom a team – Quality Operations, Process Quality Engineering and QMS to be a capable and high functioning team.
· Establish quality and reliability standards by constantly fine-tuning processes and procedures for the facility.
· Collaborate with R&D, Operations, Supplier Quality, to drive continuous product quality improvements.
· Champion best practices for quality of design transfer to manufacturing, including incoming and in-process test method development and validation.
· Work closely with various QA Leaders in the respective countries.
· Facilitate and ensure compliance for FDA inspections, internal audits and any other external audits.
The Successful Applicant
To be successful in
this role you should more than 10 years of experience managing a team with strong
knowledge of FDA, ISO, & GMP regulations. You should have strong understanding
of Process Validation with a strong passion for continuous improvement projects
as the business places a high emphasis on this.
What’s on Offer?
You will be in an organisation that promotes growth and learning with great transparency to their employees.