Senior Associate Quality Assurance

About the role

Senior Associate QA responsible for quality and compliance oversight of raw material suppliers. Works with cross‑functional team (operations, analytical science, process development, supply chain). Performs QA contact on quality events, change control, CAPA, SOPs, GMP/GDP compliance, risk management, supplier monitoring, audits, inspections, quality assessments, change approvals, operational improvement initiatives, metrics ownership. Supports global time zones, may work shifts.

What you’ll do

• Perform QA contact on quality events, change control, CAPA
• Collaborate with stakeholders to ensure GMP/GDP compliance
• Prepare, review, approve SOPs and GMP/GDP docs
• Collaborate with suppliers to enforce quality agreements
• Integrate risk management into raw material lifecycle
• Support supplier monitoring oversight activities
• Assist with internal/external audits and inspections
• Assess quality and approve changes to inspection profiles
• Drive operational improvement initiatives and projects
• Own supplier metrics and performance assessments
• Work independently with minimal supervision
• Support global time zones, shifts, extended hours

What you’ll bring

• Master’s + 1‑3 yrs OR Bachelor’s + 3‑5 yrs OR Diploma + 7‑9 yrs
• Understand GMP/GDP requirements
• Familiar with raw material compendial testing
• Oversee supplier quality or external parties
• Strong technical writing skills

Nice to have

• Digital tools/computerized systems experience
• Lean continuous improvement and change management
• End‑to‑end supply chain business process knowledge
• Project management across multiple departments/geographies
• Strong analytical/problem‑solving skills
• Independent self‑starter, autonomous, under pressure
• GMP/GDP knowledge and pharma regulations
• Energetic, detail‑oriented, motivated
• Effective written/verbal communication
• Microsoft Office (Excel, Word, PowerPoint) proficiency
• Multi‑task and prioritize

Skills

Education

Bachelor