Job TitleOneSource Account Quality Specialist
Location(s)GSK (Haleon) (Richmond) - Customer Site VA
Job DescriptionQMS Oversight & Compliance- 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
Quality Leadership & Coordination- 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
Auditing & Inspection Readiness (Proactive Focus)- Plan and conduct internal, supplier, and process audits
- Support customer, self-inspections, and regulatory inspections
- Track audit findings, non-conformances, and CAPA effectiveness
Deviation, CAPA & Change Control (Reactive Support)- 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
Training & Quality Awareness- 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
Supplier Quality Oversight- Support supplier qualification, audits, and performance monitoring
- Ensure supplier compliance with QMS and Quality Agreement
- Address supplier-related quality issues with stakeholders
Continuous Improvement- 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
Basic Qualifications- Bachelor's degree in a relevant field or equivalent professional experience with a minimum 3 years' experience 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
- Must communicate fluently in English.
- Ability to lead and influence without direct authority
- Strong analytical, problem-solving, and decision-making skills
- Excellent communication and stakeholder management skills
Preferred Characteristics- 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, ServiceMax, SharePoint, Microsoft Excel, Word, and PowerPoint.
- Certified Quality Auditor (CQA) or equivalent certification
- Experience with Lean / Six Sigma methodologies
- Experience working in customer-embedded or outsourced service environments
Working Environment- Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.).
- Employee may be required to handle hazardous waste according to local, state, and federal regulations. Duties may include identifying, handling, generating, accumulating, storing and labeling hazardous waste.
- Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals.
- May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator as protection against hazards present in the laboratory environment.
The annual compensation range for this full-time position is $80,000 to $90,000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.
