Jason Johal at CK Science is currently recruiting for a CPO Quality Unit Head to join a global pharmaceutical company based in Surrey on a full time, permanent basis.
The CPO Quality Unit Head will ensure quality governance and quality planning in the Country organization through the implementation of quality systems and processes and the annual Quality Plan. They will also prevent significant quality issues or regulatory non-compliance which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the financial performance of the company as well as the reputation.
If successful, you will be joining a CPO Leadership Team that reports functionally to Global QA for a Global Pharma company. In return there is an attractive salary, coupled with excellent benefits and career progression opportunities.
As CPO Quality Unit Head you will:
- Lead the local QA organization to ensure implementation, maintenance and upgrading of the local Quality System and Standard Operating Procedures in order to drive compliance of all cGXP and Pharmacovigilance related processes and tasks with local/International regulatory requirements and the Novartis Quality Manual
- Ensure quality governance and quality planning in the Country organization through the establishment and implementation of the annual Quality Plan, the Country Quality Review Board, appropriate Key Quality Indicators, and Quality Risk Assessments.
- Lead the country Quality Review Board
- Ensure Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) oversight and quality & compliance of Development and Medical Affairs (MA) projects, products and programs (Phase I through Phase IV)
- Ensure that co-ordinated contact is maintained with the local Regulatory Authorities, the local partners (suppliers, third parties, licensees, and distributors) and Pharma Global Quality Assurance
- Ensure that all drug products are released in accordance with the registered specifications and are released to the market in accordance with local/international regulations and ensure that a respective Change control procedure is in place
- Ensure CPO readiness for all GxP regulatory inspections.
- Ensure management of external inspections, complaints, recalls, counterfeits and product tampering according to the Company Quality Manual and local written procedures.
- Ensure that local audits are performed within the CPO organization and at 3rd parties, as appropriate.
Qualifications and skills:
The successful CPO Quality Unit Head will have the following qualifications, skills & experiences:
- Extensive experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, clinical development or production or a directly related area
- Strong leadership skills
- The ability to build the team according to requirements.
- QP status would be advantageous
- Strong knowledge of GMP and/or GCP
- Degree in Life Sciences or related fields
For more information or to apply for this CPO Quality Unit Head role please contact Jason Johal via email firstname.lastname@example.org or 01438 723 500. Please quote reference ST24492 in all correspondence.