QC Operations Manager
An international biotechnology company is recruiting a QC Operations Manager to their UK office. The organisation focuses on gene therapy to treat the suffering of people suffering from chronic systemic diseases. With a next-generation gene therapy platform to provide treatments for a wide range of diseases, this position represents an exciting opportunity to work with a leading company.
- Work closely with the Dir. Quality Control in the establishment, development, and operation of the systems and processes for the company's QC capability, covering both in-house and external testing, in GMP and GCP arenas.
- Work 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 the company'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.
Skills and Requirements:
- 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. Qualification in project management or Operational Excellence/Lean Sigma practice an advantage.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Joshua Godden at + 442038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.