Senior Quality Assurance Customer & Project Lead

Be the First to Apply 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 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.

• Regulatory and corporate requirements:
  Adhere to applicable FDA, EMA, ICH, OSHA, corporate Quality, safety, health, and environmental requirements, policies, and practices.
• Values:
  Consistently support and demonstrate Piramal Pharma Solutions mission, values, and standards of ethical conduct.

• 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 elevate 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 escalates 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,…