Responsibilities

QMS 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.