ROLE AND RESPONSIBILITIES:
• To work closely with the Dir. Quality Control in the establishment, development and operation of the systems and processes for Freeline’s QC capability covering both in-house and external testing, in GMP and GCP arenas.
• Working with the QC function heads and Project leads to establish and operate planning processes for short, mid and long-term testing, introduction of technological advances and capacity creation.
• Co-ordinate and manage QC service provision for Freeline’s product development programs
• Develop and track KPIs for critical business deliverables
• Support planning and execution of projects to establish and expand new internal lab services and capacity
• Develop and maintain systems for managing contracts and budgets for external testing at 3rd party suppliers
• Ensure ongoing update of the QC business plan and work with the team to develop resource/capacity proposals to meet future business needs
• Drive development and implementation of policies and procedures and work with QA to ensure optimal design of QMS
• Project manage/lead substantial systems projects such as LIMS implementation, QC documentation generation and archiving
• Health, Safety and Environment committee representation
• Secretary for departmental meetings
• Ensure all operations are conducted in compliance with required standards, regulations and guidance.
QUALIFICATION, EDUCATION AND EXPERIENCE REQUIREMENTS
• Required: Educated to degree level or equivalent in an analytical or biological/physical science discipline
Experience & skills
• Strong background in QC and/or development analytical settings in pharma/biotech
• Strong understanding and demonstrable experience of the application of GxP requirements including design and implementation of SOPs/systems for regulated environments
• Experience of working with or at test house CROs
• Experience of preparing for, hosting and/or delivering audits, internally and/or externally and of with regulatory inspections
• Experience of participating in or leading analytical and manufacturing investigations.
• Experience of working in a continuous improvement environment / implementing lean methodologies.
• Strong project planning skills with familiarity with MS project and typical Project Management tools.
• Demonstrates strong analytical and problem-solving skills.
• Excellent verbal and written communication, presentation and computer literacy skills.
• Excellent interpersonal and facilitation skills.
• Experience of cross-functional/matrix team working.
• Ability to work both autonomously and within a multi-disciplinary team environment.
• Qualification in project management or Operational Excellence/Lean Sigma practice an advantage
Permanent, Full time