Job Title
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 completion with responsible functions.
• Risk, Metrics and Escalation: Maintain accurate dashboards and trackers for release cycle time, quality event closure, CAPAs, complaints, audits, APQRs/PQRs, and customer commitments. Analyze status, identify emerging risks, recommend recovery actions, and escalate significant issues.
• Cross-Functional Coordination: Work with Manufacturing, Quality Control, Technical Services, Validation, Regulatory Affairs, Supply Chain, Project Management, and other functions to resolve Quality issues, align priorities, obtain required inputs, and meet program milestones.
• Continuous Improvement: Use metrics, lessons learned, risk assessments, recurring issue trends, and customer feedback to recommend and implement improvements in right-first-time performance, cycle time, investigation quality, documentation, and customer experience.
• Documentation and Data Integrity: Create and maintain complete, accurate, contemporaneous, attributable, and traceable records in approved systems. Ensure controlled documents, correspondence, trackers, and evidence packages are inspection-ready and compliant with data integrity expectations.
• Inspection and Regulatory Support: Support regulatory inspections, internal audits, and corporate assessments by preparing records, responding to requests, coordinating subject-matter inputs, documenting commitments, and tracking assigned actions to closure.
• Workload Ownership: Independently manage multiple customer and product priorities, communicate constraints early, meet agreed deadlines, and provide transparent status updates. Seek timely decisions when priorities conflict or commitments are at risk.
• Quality Culture: Demonstrate accountability, sound Quality judgment, respectful challenge, proactive communication, and a patient- and product-focused compliance mindset. Share knowledge and support onboarding or peer training as assigned.
EDUCATION / EXPERIENCE
• Education: Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, Life Sciences, or a related scientific discipline is required. An advanced degree is preferred.
• Industry Experience: Minimum five (5) years of Quality Assurance experience in pharmaceutical, biotechnology, or regulated life sciences, including work in a cGMP manufacturing environment.
• CDMO Experience: Experience supporting multiple customers, products, and concurrent project deliverables in a CDMO/CMO environment is strongly preferred.
• Customer and Project Quality: Demonstrated experience supporting customer-facing Quality activities and partnering with Project Management and cross-functional teams to meet project milestones.
• Quality Operations: Hands-on experience with several of the following: batch disposition, deviations, investigations, OOS/OOT events, complaints, CAPAs, APQRs/PQRs, change controls, customer audits, and Quality Agreements.
• Regulatory Knowledge: Working knowledge of 21 CFR Parts 210 and 211, EU GMP, ICH guidance, data integrity expectations, and risk-based Quality decision-making.
• Systems: Experience with electronic Quality systems such as TrackWise, MasterControl, Veeva, SAP, or comparable platforms is preferred.
JOB COMPETENCIES
• Strong individual ownership, organization, prioritization, and follow-through across multiple concurrent commitments.
• Customer-focused communication with sound, independent Quality judgment and appropriate escalation.
• Excellent written, verbal, presentation, and stakeholder-management skills.
• Demonstrated investigation, root-cause analysis, problem-solving, technical writing, and risk-assessment capability.
• Ability to influence without direct authority, coordinate cross-functional contributors, and hold action owners accountable for timely execution.
• Ability to balance patient and product protection, regulatory compliance, customer commitments, and business continuity.
• Proficiency in preparing clear dashboards, status reports, customer correspondence, and inspection-ready documentation.
• Ability to work effectively in a changing, deadline-driven CDMO environment while maintaining accuracy and compliance.
PHYSICAL DEMANDS AND WORK ENVIRONMENT
Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions.
• Extended periods of sitting, walking, typing, computer use, virtual meetings, and document review may be required.
• Work may include limited exposure to manufacturing, laboratory, and warehouse environments.
• Required personal protective equipment may include safety glasses, lab coats, gloves, specialized clothing, and appropriate footwear.
• Occasional lifting, bending, stooping, squatting, pushing, or pulling may be required.
