OneSource Account Quality Specialist

Job Title

One Source Account Quality Specialist

GSK (Haleon) (Richmond) - Customer Site VA

• Ensure effective implementation and adherence to the QMS and Quality Agreement
• Monitor compliance, identify risks, and drive resolution of gaps
• Partner with customer quality to maintain and update the Quality Agreement
• Act as the primary on‑site quality SME and escalation point
• Lead and coordinate quality activities across the account team
• Promote a strong quality culture and influence without direct authority

• Plan and conduct internal, supplier, and process audits
• Support customer, self-inspections, and regulatory inspections
• Track audit findings, non-conformances, and CAPA effectiveness

• Oversee and support investigations, root cause analysis, and CAPA
• Ensure timely closure of quality events with minimal operational impact
• Review and approve quality records in line with delegated authority

• Own the site quality training program with site leadership
• Deliver GMP and QMS training and ensure compliance and effectiveness
• Drive awareness and accountability for quality across all site employees

• Support supplier qualification, audits, and performance monitoring
• Ensure supplier compliance with QMS and Quality Agreement
• Address supplier-related quality issues with stakeholders

• Support delivery of the site quality plan and improvement initiatives
• Analyze quality trends and drive actions to enhance performance
• Report on quality metrics and audit outcomes to stakeholders

• Bachelor’s degree in a relevant field or equivalent professional experience with a minimum of 3 years in quality assurance within a GxP/pharmaceutical environment
• Demonstrated experience with QMS processes (deviations, CAPA, change control, audits)
• Strong knowledge of GMP and regulatory expectations
• Fluent in English
• Ability to lead and influence without direct authority
• Strong analytical, problem‑solving, and decision‑making skills
• Excellent communication and stakeholder management skills

• Strong working knowledge of Quality Management Systems in GxP environments
• Proficiency in auditing (internal, supplier, and external inspection readiness)
• Solid understanding of GMP regulations and Good Documentation Practices
• Ability to balance proactive and reactive quality priorities in a dynamic environment
• Proficiency in SAP, Service Max, SharePoint, Microsoft Excel, Word, and Power Point
• Certified Quality Auditor (CQA) or equivalent certification
• Experience with Lean/Six Sigma methodologies
• Experience in customer‑embedded or outsourced service environments

• Must be able to work in a laboratory or other controlled environment requiring personal protective equipment (e.g., lab coat, safety glasses)
• Employee may handle hazardous waste per local, state, and federal regulations; duties may include identifying, handling, generating, accumulating, storing, and labeling hazardous waste
• Potential risks include extreme temperature, biological materials, and hazardous chemicals
• May require Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator in the laboratory environment

The annual compensation range for this full‑time position is $80,000 to $90,000. The final base pay offered will be determined by internal equity, work location, and individual qualifications.

Perkin Elmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, veteran status, or any other characteristics protected by applicable law.