QA – Product Quality Continuous Improvement Leader

Role Summary:
We are offering you an exciting workplace where you are playing a key role in our business and for our customers by driving improvements in our quality operations at the Uppsala Site, in Sweden. The Product Quality Continuous Improvement leader will report into QA and closely partner with site operations to drive product quality & process improvements resulting from internal & external data insights.

Essential Responsibilities:
In this role, you will represent the voice of the customer, identifying/influencing/leading Process and Product Quality Improvement Priorities, be responsible for coaching teams on Process Improvement Tools, drive the internal audit program, and report out results to the business leadership team.
Drive product quality & process improvement priorities based on trends from internal and external data
Coach/SME to X-functional members on RCA and process improvement tools
Lead X-functional teams to support with Product Quality Improvement priorities
Drive the development of site metrics, KPI's and trending
Take an active part in the site Internal audit program and use the output to drive process and product quality improvements
Support in customer interactions related to RCA and process improvements
Responsible for supporting report-outs to business leadership on improvements activity execution & performance as well as with regular report-outs for process performance metrics

Qualifications/Requirements:
Technical- /Chemical degree/or degree in the quality/health sciences field; or significant leadership experience in a Quality or Regulatory Assurance related field
Experience of quality standards such as ISO9001 and/or ISO13485 its application and requirements
Demonstrated experience leading product quality and process improvement projects
Can effectively communicate with all levels of the organization around the concepts of the QMS and process & product quality improvements
Demonstrated ability to use data/statistics/trends to drive improvements
Excellent written and spoken English and Swedish

Desired Characteristics:
Product-specific knowledge of Chromatography Media /Resins & in-depth understanding of related QMS processes
Experience of cGMP requirements
CAP coach / understanding of the Change Acceleration Process
Demonstrated knowledge of continuous improvement methodologies (i.e 6 Sigma/DMAIC)
Accountable for actions and results
Resourceful - seek simple solutions and effectively use internal /external resources