Quality Business Partner - Development

Site Name: UK – London – New Oxford Street, Belgium-Wavre, GSK Tres Cantos, Madrid, Italy - Siena, UK - Hertfordshire - Stevenage Posted Date: Nov 7 2024 Quality Business Partner - Development Location: GSK HQ/Stevenage (UK), US The purpose of the role is to be the quality advocate for their given area of responsibility.
The Quality Business Partner will provide strategic, expert advice and consultation on RD quality with impact across the regulatory and quality area of responsibility.
The role will educate assigned groups on Quality by Design, regulatory compliance risk minimization and mitigation.
The QBP will help the business and TP understand potential impact of Quality risks and alternatives to best address the risk.
Will help RD design and implement strategies for quality and getting right first time as well as oversight according to the GSK ICF.
Key Responsibilities include, but are not limited to: Provides matrix management and leadership to cross-functional teams.
Serves as the Quality Business Partner for assigned GSK RD functions, programs and/or Third Parties.
Works closely with business to provide expert quality information, manage identified issues and support continuous improvement.
Collaborates with the Audit, Inspection, Risk and Issue Management team within RD 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 QMS.
Influences senior leaders to foster a commitment to quality and a culture of quality across GSK and GSK Third Parties.
Responsible for quality consultation for the assigned function.
Defines, implements and monitors the quality narrative/quality brief and reports any critical risk.
Works with RD Data Analytics to define KPI, KQI and metrics needs for RD Quality and Risk Management and stakeholders.
Shares key learnings to drive simplification, continuous improvement and replicate best practices to drive quality into the business.
Defines the activities that need to be conducted to deliver the quality strategy for the assigned function, program and/or Third Party.
Supports due diligence and Merger Acquisition activities.
Ensures rapid communication of quality issues and risks including potential misconduct to appropriate leaders and colleagues.
Supports the investigations of potential serious breaches and critical issues.
Leads special assignments on various projects and workstreams as determined by RD Quality and Risk Management LT. Why you?
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience.
5 or more years of Pharma experience.
Experience in drug development, regulatory compliance or quality management.
Experience in clinical, medical, pharmacovigilance or regulatory quality.
Expert knowledge of GCP, GVP regulatory requirements.
Preferred Qualifications: If you have the following characteristics, it would be a plus: Broad working knowledge/expertise in principles and concepts of quality by design 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.
Closing Date for Applications: 22nd November 2024 (COB) 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 practices; 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.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years.
RD is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease.
Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery.
We are revolutionizing the way we do RD.
We're uniting science, technology and talent to get ahead of disease together.
Find out more: Our approach to RD.
#LI-Hybrid 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 organization 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).
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If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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