- 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.
- 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
- Complementary experience in manufacturing management roles highly desirable
- PhD
- Inspirational leadership, managerial development experience skills to lead and motivate a diverse, high-performance team of internal and external Business Partners/Providers and Regulatory organisations.
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Head of Quality ViiV Healthcare - Brentford, United Kingdom - GlaxoSmithKline
Description
Site Name: UK - London - BrentfordPosted 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. At GSK HQ, we're building an energising space where we can connect, collaborate and get ahead of disease together. 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 is highly mission-driven in our unrelenting commitment to leave no person living with HIV behind. We do this by being a trusted partner for all people living with and affected by 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. Our work culture is fast-paced, diverse, inclusive, competitive, and caring. 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:
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Please apply via our online portal providing your CV and Cover Letter.
(Please take a personal copy of the Job Description, as this will not be available online post closure of the advert)
Closing Date: 18th May 2024
Location: The role will initially be based at GSK House, Brentford, moving to Central London during H Hybrid working applies to this role, with ViiV expectation of minimum 2 days per week being office based.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK
Why Us?
At ViiV Healthcare, we will not rest until we leave no person living with HIV behind. Until the 39 million people living with HIV is down to zero, we will continue searching for new ways to limit the impact of HIV.
We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS. At ViiV Healthcare, we do things differently. Born out of a partnership between GSK and Pfizer in 2009, with Shionogi joining in 2012, we are determined to help end the HIV epidemic. We are guided by our mission to leave no person living with HIV behind and it is this mission that unites our employees located across the globe. We combine expertise in research, manufacturing, policy and more to push the boundaries of what people think is possible in HIV treatment and care. As a result of our connection with GSK, we are able to draw on their proud history and resources. This means that you would receive all the employee benefits offered by GSK.
Living our mission of leaving no person living with HIV behind means keeping inclusion and diversity at the heart of everything we do - from our breakthrough innovation, to our diverse portfolio of medicines as well as the work we do to partner with HIV communities. Having a diverse team and a truly inclusive culture where we're all able to be ourselves and feel like we belong will make us an even stronger team, better able to perform as a business and deliver on our mission to leave no person living with HIV behind.
ViiV is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
ViiV does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV. ViiV shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit ViiV's Transparency Reporting For the Record site.
