
Biopharmaceutical Quality Director
5 days ago
About Danaher - Global
">We are seeking an experienced Quality Assurance Professional to lead our Uppsala site Quality Assurance organization and Quality Management System (QMS). This role will report directly into the Global QARA organization and is based onsite at our Uppsala site.
Key Responsibilities
- Represent the Uppsala site as the lead Quality Management Representative Responsible for the leadership & development of the Uppsala QA function.
- Support the Global QMS team on Global process and procedure changes and represent the needs of the site during change management and continuous improvement discussions.
- Monitor and Report Quality KPI's including, reporting on performance/trend insights within business reviews.
- Ensure adequate QA support to Site Projects, including new product development.
- Evaluate and Improve QMS procedures, work instructions, and IT System effectively supporting the Uppsala organization - Collaborate with Global QMS systems, documentation control and training leaders as required.
- Cultivate effective communication style with stakeholders and establish cross-functional operating mechanisms, where appropriate to ensure Quality goals are met.
Requirements
- Bachelor's Degree in a Science or Engineering discipline.
- Extensive Experience working in Quality Assurance/Quality Engineering within Life Science, Medical Device or Biopharma manufacturing environments.
- Senior Leadership experience within Quality Assurance/Quality Engineering.
- Comprehensive Understanding, comprehensive understanding of ISO 9001 & ISO 13485 requirements.
- Excellent Communication skills (written and oral), fluent in both Swedish & English.
- Project Management experience, managing project teams and working cross-functionally, both locally & globally.
- Analytical Skills, exceptional analytical, problem-solving & root-cause analysis skills.
- Product Life Cycle, demonstrated expertise to effectively communicate within all levels of the organization around the entire product life cycle management (design controls, verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management, services).
- Continuous Improvement, experienced in continuous improvement methodologies & tools (i.e. LEAN six sigma, DBS, SPC and data trending).
Preferred Qualifications
- GMP Requirements.
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