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Head of Quality Viiv Healthcare
3 months ago
Site Name:
UK - London - Brentford
Posted Date:
May 2 2024
We're excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024.
Designed especially for us, it'll be one of the healthiest workplaces in the world, with best-in-class tech and bright, light spaces to help us thrive.
Head of Quality, ViiV Healthcare:
ViiV Healthcare is a global specialty HIV company, the only company that is 100% focused on researching and delivering new medicines for people living with, and at risk of, HIV.
ViiV has played a significant part in delivering breakthroughs that have turned HIV into a manageable health condition.
We offer the largest portfolio of HIV medicines available anywhere, and we continue our work to cater for the widest possible range of needs in response to the HIV pandemic.
We are aware of how much is at stake for those affected by HIV and we show up every day 100% committed to the patients.
But ViiV isn't just somewhere to work - it's a place to belong, an invitation to bring your very best, and a team full of impact-driven team members who are eager to make a difference.
As our Head of Quality, you will Provide quality leadership in support of all aspects of the ViiV business.This includes working with ViiV Central functions and Local Operating Companies, GSK R&D, GSK Supply Chain, Pfizer, Shionogi and third party business partners and suppliers.
Key Responsibilities:
- To ensure that ViiV, as a Manufacturing Authorisation holder (MAH), has a comprehensively designed and correctly implemented quality system incorporating good manufacturing practice, good distribution practice and quality risk management.
- To ensure that the ViiV Leadership continue to support the quality system and ensure the commitment of staff at all levels and all locations within the organisation.
- To ensure that all suppliers, including GSK/GSC as ViiV's major supplier, follow their own product quality systems. This would include oversight of factory compliance and quality performance to adequately protect ViiV's commercial and compliance business risks.
- To work as part of the GSK's GSC Quality Organisation to ensure there is independence of decision making and to ensure that all activities subcontracted to GSK under the Support Services Agreement are implemented efficiently and effectively.
- To work as part of the GSK's GSC Quality organisation to ensure that ViiV has access to the necessary Quality resources with necessary competencies to fulfil its quality responsibilities as an MAH.
- To work as part of the GSK's GSC Quality organisation to influence and discuss quality strategies that could, as GSK is the major supplier, impact the ViiV supply chain.
- To ensure that risks that could affect the quality for the products for which ViiV are the MAH are adequately managed.
- To be the ViiV Quality representative on the appropriate governance boards throughout the lifecycle of products (R&D, manufacturing and supply)
- To chair ViiV quality governance boards (ViiV Quality Council).
- To be the Quality representative on the ViiV Recall Board
- Fulfil all responsibilities as Responsible Person in the worldwide virtual wholesale distribution operations of ViiV Healthcare Trading Services UK Limited
- Fulfil all responsibilities defined in EU GDP Guidelines 2013/C 343 Chapter 2, Paragraph 2.2 as Responsible Person for Wholesale Distribution of Medicinal Products. Define where the duties are delegated to meet the responsibilities of the Responsible Person and Designated Person.
Why You:
Basic Qualifications:
- We are looking for professionals with these required skills to achieve our goals:_
- Degree in a relevant scientific discipline (e.g. Chemistry, Biology or Pharmacy) and significant relevant experience in senior Quality positions
- A broad based technical knowledge of critical aspects of manufacturing, quality and regulatory activities and requirements associated with production and distribution of pharmaceuticals.
- In depth understanding of Quality and cGMP/cGDP applicable within the pharmaceutical industry, developed though demonstrated experience in Operational Quality
Preferred:
- Complementary experience in manufacturing management roles highly desirable
- PhD
- Inspirational leadership, managerial development experience skills to lead and motivate a diverse, highperformance team of internal and external Business Partners/Providers and Regulatory organisations.
Interested in Joining the Team?**:
(Please take a personal copy of the Job
