QC Operations Manager

  • Freeline
  • Job type: Permanent
  • Closing by 30/10/2019
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Description

 

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

Education

• 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.

Other

• 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

Job type

Permanent, Full time

Location

Stevenage, UK

Apply now

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