GSK
Associate Director, Quality Business Partner
Competitive salary and benefits
Job Function:
Regulatory
Job Type:
Location:
Stevenage
Based:
Closing date:
ABOUT THE ROLE
Job Description
Site Name:
UK – London – New Oxford Street
- Durham Blackwell Street
- Japan - Tokyo - Akasaka
- UK - Hertfordshire - Stevenage
- USA - Pennsylvania - Upper Providence
Posted Date: Oct 31, 2024
Position: Associate Director, Quality Business Partner
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. This is a truly exciting position as the Associate Director, Quality Business Partner will be the quality advocate and change agent for their given area of responsibility.
Key Responsibilities:
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).
- Drive quality into business by educating assigned groups on Quality by Design, regulatory compliance, risk minimization, and mitigation.
- Help the business and Third Parties understand potential impact of Quality risks and alternatives to best address the risk.
- Assist R&D in designing and implementing strategies for quality and getting it right the first time, as well as oversight according to the GSK Internal Control Framework.
In this role you will:
Serve as the Quality Business Partner for assigned GSK R&D functions, programs, and/or Third Parties.
- Work closely with the business to provide expert quality information, manage identified issues, and support continuous improvement.
- Provide matrix management and leadership to cross-functional teams.
- Collaborate 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.
- Lead inspection readiness activities and support regulatory inspections.
- Support issues identification, reporting, root cause analysis, and CAPA development.
- Evaluate and/or review standard operating procedures and other activities in support of an integrated, cross-functional Quality Management System.
- Influence 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 2024
Please 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.
REQUIREMENTS
Qualifications and Experience:
Degree: Qualified in a scientific or engineering discipline, or able to demonstrate an equivalent level of knowledge.
- Experience:
- Drug development
- Regulatory compliance
- Quality management
- Clinical, medical, pharmacovigilance, or regulatory quality
- Expert Knowledge:
- GLP (Good Laboratory Practice)
- GCP (Good Clinical Practice)
- GVP (Good Pharmacovigilance Practice)
- Regulatory requirements
- Proven Experience:
- Interfacing and influencing senior Global Leadership team stakeholders
- Leading cross-functional projects and/or matrix teams to an aligned strategy
Preferred Qualifications and Skills:
Education: BA/BS or Masters Degree
- Knowledge/Expertise:
- Principles and concepts of quality by design
- Quality briefs and risk management
- Continuous improvement with a background in appropriate tools
- Quality Orientation:
- Focus on details and adherence to standards while maintaining a business perspective
- Analytical Mindset:
- Develop effective quality strategies for dealing with current and future industry trends
- Adaptability:
- Ability to adapt to changing direction and needs of the business
- Apply knowledge directly into daily tasks and assignments
- Communication Skills:
- Effective communication/negotiation skills
- Customer management skills
About Us:
We make and supply medicines and vaccines globally. Our teams manage 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.
Our Scale:
Producing over 2.3 billion packs of medicines and doses of vaccines in 2023.
- Continuously modernizing to launch new products quickly while maintaining quality, safety, and service across our portfolio.
Future Outlook:
Embracing technological and product shifts, which for some will be revolutionary.
- Our R&D pipeline requires a new kind of supply chain.
- Seeking the best minds and capabilities to help us make more complex products.
- Utilizing smart manufacturing technologies, including robotics, digital solutions, and artificial intelligence, to deliver for patients.
Interested in Joining Us?
Find out more in our [Annual Report 2023]](#).
ABOUT THE COMPANY
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. Our goal is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns, all while creating an environment where people can thrive.
Our Mission:
Prevent and Treat Disease: We offer vaccines, specialty, and general medicines.
- Focus Areas: We concentrate on the science of the immune system and leverage new platform and data technologies, investing in four core therapeutic areas:
- Infectious diseases
- HIV
- Respiratory/Immunology
- Oncology
Our People:
Our success absolutely depends on our people. While our mission is to get ahead of disease together for the benefit of patients and shareholders, it’s also about making GSK a place where people can thrive. We aim to create an environment where:
People feel inspired, encouraged, and challenged to be their best.
- Everyone feels welcome, valued, and included.
- Employees can continue to grow and look after their wellbeing.
Join Us:
If you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Equal Opportunity Employer:
We are committed to being an Equal Opportunity Employer and adhere to Affirmative Action principles in the US. 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
- Any other federal, state, or local protected class (*US only)
Agile Working Culture:
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore the opportunities with our hiring team.
Adjustments and Support:
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, please contact us at:
- Phone: 0808 234 4391
Please note, if your enquiry does 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 link and scroll to the Careers Section where you will find answers to multiple questions we receive.
Personal Information:
As you apply, we will ask you to share some personal information, which is entirely voluntary. This information helps us consider a diverse pool of qualified candidates and understand how well we are doing against our inclusion and diversity ambitions. We would 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.
HOW TO APPLY
