Director, Quality Business Partner

Job title:

Director, Quality Business Partner

Company

GlaxoSmithKline

Job description

Director, Quality Business Partner – Third PartyThis 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

CLOSING DATE for applications: 21st November 2024Please take a copy of the Job Description, as this will not be available post closure of the advert.During the course of your application, you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.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.
• Ability to adapt to changing direction and needs of the business; can directly apply this knowledge into daily tasks and assignments.
• 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: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 returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0808 234 4391.Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the and scroll to the Careers Section where you will find answers to multiple questions we receiveAs you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.Important notice to Employment businesses/ AgenciesGSK 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 GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. 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 GSK. GSK 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, GSK may be required to capture and report expenses GSK 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 GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting site.

Expected salary

Location

Stevenage, Hertfordshire

Job date

Sun, 03 Nov 2024 00:20:08 GMT

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