This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
This role will be responsible for managing the Separation Sciences and in-process team while owning, facilitating, and undertaking activities pertaining to QCSS within QC. The successful candidate will focus on compliance, continuous improvement and implementing a lean culture and Right First Time (RFT) for QCSS duties and testing, including release/stability/in process of commercial product. The role also represents the QC unit by liaising with internal and external stake holders. The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.
Job Responsibility
Supervision/Management of QC Separation Sciences including In-process team
Responsible for providing Quality oversight to ensure that operations products are manufactured, tested, stored and distributed according to current cGMP, GDP and other applicable regulations
Provides coaching, feedback and mentoring to ensure team development
Builds relationships and collaborates cross functionally with ADL and Network colleagues to share lessons learned and improvements
Ensures deviations from established procedures are investigated and documented per procedure
Represents QC during Audits and Inspections regarding preparation and participation
Represents QC at site and network level
Supports Continuous Improvement and Error management initiatives, programs and projects
Works with minimal supervision but knows when to escalate or look for support
Requirements
Bachelor's degree in a Science related field is required. 6+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, with of 2 – 3 years of specific QC laboratory management experience is desirable
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating
Proven experience of leading teams
Nice to have
Specific knowledge HPLC, Capillary Electrophoresis and SDS/IEF Gels is an advantage
Experience leading cross-functional teams is desirable