Quality Business Partner, Third Party (R&D Quality and Risk Management)

GSK; Greater London; Hybrid; GBP 122,000 - 205,000; Full time

Job summary

A leading pharmaceutical company in Greater London is seeking a Quality Business Partner for R&D to provide expert quality advice and oversee Third Party services. The role emphasizes strategic quality influence, regulatory compliance, and the development of effective quality strategies. This position offers competitive compensation, including an annual bonus and comprehensive benefits. Ideal candidates will possess a Bachelor's degree and extensive expertise in Clinical Quality Assurance and Third Party quality management.

Benefits

Annual bonus

Health care and insurance benefits

Retirement benefits

Qualifications

• Bachelor's degree or equivalent in a scientific or quality-related field.
• Clinical Quality Assurance expertise.
• Experience in clinical medical pharmacovigilance or regulatory quality.

Responsibilities

• Serve as the Quality Business Partner for assigned R&D Third Party services.
• Define quality strategies and monitor implementations.
• Lead inspection readiness and support regulatory inspections.

Skills

Clinical Quality Assurance expertise

Experience in Third Party quality management

Analytical mindset

Effective communication skills

Problem-solving skills

Collaboration across diverse teams

Education

Bachelor's degree in a scientific or quality-related field

Job description

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 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

• Bachelor's degree or equivalent in a scientific or quality-related field, or equivalent combination of education, training and experience.
• Clinical Quality Assurance expertise.
• Experience in Third Party quality management and oversight.
• Experience in clinical medical pharmacovigilance or regulatory quality.
• Experience in GxP (GCP, GLP) regulatory requirements.
• Broad working knowledge and 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.

Preferred Qualifications

• 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.
• Excellent problem‑solving skills.
• Proven ability to collaborate across diverse teams.

Hybrid

The US annual base salary for new hires in this position ranges from $163,350 to $272,250. The US salary ranges consider work location within the US market, candidate skills, experience, education level, and the market rate for the additional position. This role offers an annual bonus and eligibility to participate in our share‑based long term incentive program, which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver / parental and medical leave. If salary ranges are not displayed for a specific country, the relevant compensation will be discussed during the recruitment process.

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.