Quality Business Partner, Third Party (R&D Quality and Risk Management)
Job Purpose
The Quality Business Partner (QBP) is the quality advocate for assigned areas of responsibility. This role will provide strategic, expert advice and consultation on R&D quality with impact across the regulatory and quality area of responsibility. The role will educate aligned 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 them, while helping R&D implement strategies for quality and getting right first time as well as oversight according to the GSK ICF.
Key Responsibilities:
• Serves as the Quality Business Partner for assigned GSK R&D Third Party services.
• Defines the activities that need to be conducted to deliver the quality strategy for the assigned Third Party services.
• Implements and monitors the quality narrative/quality brief, reports any critical risk and the quality position/statement.
• Works closely with business and/or Third Party teams to provide expert quality information and support continuous improvement.
• Leads inspection readiness activities and supports regulatory inspections.
• Evaluates, and/or reviews procedures and other activities in support of an integrated, cross functional QMS.
• Fosters a commitment to quality in individuals and a culture of quality across GSK and GSK Third Parties. Facilitates effective communication and knowledge sharing across teams to promote a culture of quality.
• Supports due diligence and Merger & Acquisition activities.
• Works with R&D Data Analytics to define KPI, KQI and metrics needs for R&D Quality and Risk Management and stakeholders.
• Ensures rapid communication of quality issues and risks including potential misconduct to appropriate leaders and colleagues.
• Supports issues identification, reporting, root cause analysis and CAPA development.
• Supports the investigations of potential serious breaches and critical issues.
• 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.
• Participates in special assignments on various projects and workstreams as determined by R&D Quality and Risk Management LT.
• Shares key learnings to drive simplification and replicate best practices to drive quality into the business.
Basic Qualifications
1. Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience.
2. Clinical Quality Assurance expertise.
3. Experience in Third Party quality management and oversight.
4. Experience in clinical, medical, pharmacovigilance or regulatory quality.
5. Experience in GxP (GCP, GLP) regulatory requirements.
6. Broad working knowledge and expertise in principles and concepts of quality by design and risk management.
7. Expert working knowledge in continuous improvement with a background in the appropriate tools.
Preferred Qualifications
8. Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective.
9. Analytical mindset to develop effective quality strategies for dealing with current and future industry trends.
10. Ability to adapt to changing direction and needs of the business; can directly apply this knowledge into daily tasks and assignments.
11. Effective communication/negotiation skills and customer management skills.
12. Excellent problem-solving skills.
13. Proven ability to collaborate across diverse teams.
LI-GSK*
Hybrid*
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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.