Sr. Quality Assurance, Customer & Project Lead

Sr. Quality Assurance, Customer & Project Lead

Job Description POSITION SUMMARY  The Senior Quality Assurance, Customer & Project Lead is an experienced individual contributor responsible for executing customer-facing Quality activities and completing assigned Quality deliverables across development, validation, commercial manufacturing, and product lifecycle programs in a CDMO environment. The role reports to the Senior QA Manager, Customer Quality & Project Assurance and works directly with Project Management, Manufacturing, Quality Control, Regulatory Affairs, Technical Services, Validation, Supply Chain, and other functions to meet customer commitments while maintaining cGMP compliance.
The position performs the detailed Quality work within the manager’s scope, including customer communications, project quality tracking, batch disposition support, quality event follow-up, complaints, CAPAs, customer audits, APQRs/PQRs, Quality Agreements, dashboards, and commitment closure. The role exercises independent Quality judgment within approved procedures and escalates significant compliance, product, patient, schedule, and resource risks to management.
** KEY

ACCOUNTABILITIES **·    
** Customer Quality Support:
** Serve as the day-to-day Quality contact for assigned customers and programs. Prepare updates, coordinate responses, support routine Quality reviews, document decisions, track open actions, and escalate matters requiring management attention.·    
** Project Quality Execution:
** Partner with Project Management to identify, plan, prioritize, track, and complete Quality activities aligned with project plans, customer expectations, technical milestones, and commercial schedules. Maintain accurate action logs and drive assigned deliverables to closure.·    
** Batch Release and Product Disposition:
** Perform or coordinate QA review of batch records, test results, deviations, investigations, certificates, and supporting documentation required for disposition. Identify gaps, obtain corrections, document status, and promptly escalate release risks while preserving independent Quality authority.·    
** Quality Events and Investigations:
** Review, author, coordinate, or follow up on deviations, nonconformances, laboratory investigations, OOS/OOT events, and product-impact assessments. Confirm that investigations are scientifically sound, risk-based, supported by evidence, and completed within approved timelines.·    
** Customer Complaints:
** Execute complaint intake, assessment, investigation coordination, response drafting, trend support, commitment tracking, and escalation. Ensure customer responses are accurate, clear, compliant, and issued within established commitments.·    
** CAPA Management:
** Develop, review, and track CAPAs to ensure alignment with root cause, assignment of accountable owners and milestones, timely completion, adequate objective evidence, and meaningful effectiveness checks.·    
** Customer Audits:
** Coordinate audit planning and readiness activities; assemble requested documents; manage audit logistics and action logs; support audit execution; draft or coordinate responses; and track commitments, CAPAs, and effectiveness verification to closure.·    
** Annual Product Quality Reviews:
** Prepare, coordinate, review, and route APQRs/PQRs for approval and customer delivery. Compile and evaluate product, process, deviation, investigation, complaint, change, and CAPA data to identify meaningful trends and required actions.·    
** Quality Agreements and Customer Commitments:
** Support the development, review, maintenance, and implementation of Quality Agreements. Track customer notifications, responsibilities, deliverables, and commitments and coordinate timely…