CPO Quality Unit Head – Surrey

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 job:

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.

Responsibilities:

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

Jason Johal  -  Manager at CK ScienceHow to apply:

Apply online:

For more information or to apply for this CPO Quality Unit Head role please contact Jason Johal via email jjohal@ckscience.co.uk or 01438 723 500.  Please quote reference ST24492 in all correspondence.

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GSK Offers to Share Scientific Data to Wipe Out Tropical Diseases

Mosquito

In recent years, pharmaceutical companies have come under increasing pressure to change their approach to providing cheap drugs to people in the developing world. Many have faced fierce criticism for their failure to drop prices for HIV drugs while millions died in Africa and Asia, for defending patents. However, it seems the Chief Executive of GSK, Andrew Witty has a plan to fix this problem.

As reported in the Daily Telegraph, GSK is planning to share scientific data and laboratories in a bid to wipe out tropical diseases, such as malaria.  Andrew Witty, the Chief Executive of GSK who recently spent time in some of the world’s poorest continents, including Africa, said the global pharmaceutical company has a “genuine appetite to change the landscape of healthcare for the world’s poorest people”. In fact, it is estimated that Africa carries 70% of the world’s healthcare burden, but only receives 3% of healthcare resources.

In 2009, GSK announced it would create a patent pool for some of its existing products and not-for-profit-pricing on a variety of drugs for the developing world. In addition, the pharmaceutical giant plans to release 13,500 of its compounds that are believed to have the potential to be developed into new malaria treatments.

GSK will also operate an ‘Open Lab’ scheme whereby the company will open one of its laboratories in Tres Santocs, Spain, for non-GSK scientists to use to investigate treatments for other tropical diseases. The lab will accommodate 60 scientists who will benefit from £4.9m of funding from GSK to help with their research.  Speaking of this innovative ‘Open Lab’ scheme, Witty stated, Speaking before leaving for New York, Mr. Witty said: “Malaria is a dreadful disease which stalks the fields and villages of many parts of the least developed world. It has been an intractable problem for decades. Enormous progress has been made through bed net programmes, for example, but a really effective treatment has been somewhat elusive. We need to enlist the help of scientists around the world and to make it as easy as possible for that brilliant scientist, wherever they are, to find that initial spark that could be the breakthrough.”

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