Director, Quality Business Partner
Il y a 2 mois
**Site Name**: UK - Hertfordshire - Stevenage, Belgium-Wavre, Durham Blackwell Street, UK - London - New Oxford Street, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
**Posted Date**: Oct 31 2024
**Director, Quality Business Partner - Third Party**
**This role will preferably be based at GSK HQ or Stevenage, UK but can also be based at other strategic locations on a case-by case basis.**
**There are two Director, QBP positions that we are recruiting for.**
This is a truly exciting position as the Quality Business Partner will be the quality advocate and change agent for their given area of responsibility. The role holder will provide strategic, expert advice and consultation on the quality strategy with impact across the regulatory and quality area of responsibility (in this case Third Parties). The role will drive quality into business by educating assigned groups on Quality by Design, regulatory compliance, risk minimization and mitigation. The QBP will help the business and Third Parties understand potential impact of Quality risks and alternatives to best address the risk.
They will help R&D to design and implement strategies for quality and getting right first time as well as oversight according to the GSK Internal Control Framework.
In this role you will:
- Serves as the Quality Business Partner for assigned GSK R&D functions, programs and/or Third Parties.
- Works closely with business to provide expert quality information, manage identified issues and support continuous improvement.
- Provides matrix management and leadership to cross-functional teams.
- Collaborates with the Audit, Inspection, Risk and Issue Management team within R&D Quality and Risk Management on all internal quality audits, regulatory agency inspections, risk assessments, issue and CAPA activities.
- Leads inspection readiness activities and supports regulatory inspections.
- Supports issues identification, reporting, root cause analysis and CAPA development.
- Evaluates, and/or reviews standard operating procedures and other activities in support of an integrated, cross functional Quality Management System.
- Influences senior leaders to foster a commitment to quality and a culture of quality across GSK and GSK Third Parties
Please take a copy of the Job Description, as this will not be available post closure of the advert.
**Required qualifications and skills**:
- Degree qualified in scientific or engineering discipline or able to demonstrate equivalent level of knowledge
- Experience in drug development, regulatory compliance or quality management.
- Experience in clinical, medical, pharmacovigilance or regulatory quality.
- Expert knowledge of GLP, GCP, GVP and regulatory requirements
- Proven experience interfacing and influencing senior Global Leadership team stakeholders
- Strong leadership skills
- Ability to lead cross functional project and/or matrix teams to an aligned strategy
**Preferred qualifications and skills**:
- BA/BS or Masters Degree
- Broad working knowledge/expertise in principles and concepts of quality by design, quality briefs and risk management
- Expert working knowledge in continuous improvement with a background in the appropriate tools.
- Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
- Analytical mindset to develop effective quality strategies for dealing with current and future industry trends.
- Effective communication/negotiation skills and customer management skills
We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2023.
We continue to modernise, so we can launch even more new products at speed whilst continuing to deliver across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
If you are interested in joining us, find out more:
Annual Report 2023
**Why GSK?**
**Uniting science, technology and talent to get ahead of disease together.**
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder re
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