Senior QA Manager, Customer Focus & Project Assurance

Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms.

We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit :

The Senior QA Manager, Customer Quality & Project Assurance leads customer-facing Quality activities and ensures on-time execution of Quality deliverables across development, validation, commercial manufacturing, and product lifecycle programs within a CDMO environment. The role serves as the primary Quality partner to Project Management and coordinates with Manufacturing, Quality Control, Regulatory Affairs, Technical Services, Validation, Supply Chain, and other functions to meet customer commitments and maintain cGMP compliance.

This role is designed as the primary Quality liaison for customer programs and would fit well within your proposed Quality organization as the leader responsible for all customer-facing Quality operations, project quality execution, customer audits, complaints, investigations, APQRs, batch disposition support, and customer satisfaction. It also provides a logical career progression path to Senior Manager, Customer Quality & Project Assurance as the CDMO business expands.

• Customer Quality Leadership:
  Serve as the primary Quality contact for assigned customers; build trusted relationships; lead routine Quality reviews and escalations; and ensure transparent, timely communication.
• Project Quality Execution:
  Partner with Project Management to define, prioritize, track, and deliver Quality activities aligned with project plans, customer expectations, technical milestones, and commercial schedules.
• Batch Release and Product Disposition:
  Coordinate timely QA review of batch records, test results, deviations, investigations, and supporting documentation required for disposition while maintaining independent Quality authority.
• Quality Events and Investigations:
  Oversee deviations, nonconformances, laboratory investigations, OOS/OOT events, and product-impact assessments. Ensure investigations are scientifically sound, risk-based, and completed within approved timelines.
• Customer Complaints:
  Lead complaint intake, investigation, response, trend review, and escalation. Ensure customer responses are accurate, clear, compliant, and issued within established commitments.
• CAPA Management:
  Ensure CAPAs address root cause, include accountable owners and milestones, are completed on time, and contain meaningful effectiveness checks.
• Customer Audits:
  Lead audit planning, readiness, execution, response development, commitment tracking, CAPA closure, and effectiveness verification. Coordinate SMEs and cross-functional support.
• Annual Product Quality Reviews:
  Oversee accurate and timely preparation, review, approval, and customer delivery of APQRs/PQRs, including evaluation of product, process, investigation, complaint, and CAPA trends.
• Quality Agreements and Commitments:
  Support development and maintenance of Quality Agreements and ensure customer notifications, responsibilities, deliverables, and commitments are clearly assigned and fulfilled.
• Risk, Metrics and Escalation:
  Maintain dashboards for release cycle time, event closure, CAPA, complaints, audits, APQRs, and customer commitments. Escalate significant quality, compliance, schedule, and resource risks with recovery plans.
• Continuous Improvement:
  Use metrics, lessons learned, risk assessments, and customer feedback to improve right-first-time performance, cycle times, investigation quality, and customer experience.
• People Leadership:
  Lead, coach, and develop approximately 4-6 Quality professionals. Set priorities and performance expectations, allocate work, build capability, and foster accountability, collaboration, engagement, and a strong Quality…