Senior QA Manager, Customer Focus & Project Assurance

Location: Northern

## Senior QA Manager, Customer Focus & Project Assurance Apply:
Onsite:
Sellersville:
Full time:
Posted Today:
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* * 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 :(Use the "Apply for this Job" box below). Title Senior QA Manager, Customer Focus & Project Assurance

Job Description 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.
** KEY

ACCOUNTABILITIES
** The incumbent oversees approximately 4–6 Quality professionals and is accountable for batch disposition, deviations, laboratory investigations, OOS/OOT events, complaints, APQRs/PQRs, customer audits, CAPAs, Quality Agreements, and related project commitments. This role leads Quality Operations, Clinical Operations, Commercial Operations, Data Auditing, and QA IT support, and serves as the Quality leadership designee as needed.·         
** 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…