Senior QA Manager, Customer Focus & Project Assurance

Piramal Pharma Ltd•Sellersville, PA

13d

About The Position

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.

Requirements

Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, Life Sciences, or a related scientific discipline is required.
Minimum eight (8) years of Quality Assurance experience in pharmaceutical, biotechnology, or regulated life sciences, including work in a cGMP manufacturing environment.
Minimum three (3) years of direct people-leadership experience, including responsibility for workload planning, coaching, development, and performance management.
Strong working knowledge of 21 CFR Parts 210 and 211, EU GMP, ICH guidance, data integrity expectations, and risk-based Quality decision-making.
Customer-focused leadership with sound, independent Quality judgment.
Strong project management, prioritization, organization, and follow-through.
Excellent written, verbal, presentation, negotiation, and stakeholder-management skills.
Demonstrated investigation, root-cause analysis, problem-solving, and risk-assessment capability.
Ability to influence cross-functional teams, manage competing priorities, and hold owners accountable for timely execution.
Ability to balance patient and product protection, regulatory compliance, customer commitments, and business continuity.
Ability to lead through change and foster a collaborative, accountable, and improvement-oriented team culture.

Nice To Haves

An advanced degree is preferred.
Experience supporting multiple customers and products in a CDMO/CMO environment is strongly preferred.
Demonstrated experience managing customer-facing Quality activities and partnering with Project Management and cross-functional teams to meet project milestones.
Experience with batch disposition, deviations, investigations, OOS/OOT events, complaints, CAPAs, APQRs/PQRs, change controls, customer audits, and Quality Agreements.
Experience with electronic Quality systems such as TrackWise, MasterControl, Veeva, SAP, or comparable platforms is preferred.

Responsibilities

Oversee 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.
Lead Quality Operations, Clinical Operations, Commercial Operations, Data Auditing, and QA IT support, and serve as the Quality leadership designee as needed.
Serve as the primary Quality contact for assigned customers; build trusted relationships; lead routine Quality reviews and escalations; and ensure transparent, timely communication.
Partner with Project Management to define, prioritize, track, and deliver Quality activities aligned with project plans, customer expectations, technical milestones, and commercial schedules.
Coordinate timely QA review of batch records, test results, deviations, investigations, and supporting documentation required for disposition while maintaining independent Quality authority.
Oversee deviations, nonconformances, laboratory investigations, OOS/OOT events, and product-impact assessments. Ensure investigations are scientifically sound, risk-based, and completed within approved timelines.
Lead complaint intake, investigation, response, trend review, and escalation. Ensure customer responses are accurate, clear, compliant, and issued within established commitments.
Ensure CAPAs address root cause, include accountable owners and milestones, are completed on time, and contain meaningful effectiveness checks.
Lead audit planning, readiness, execution, response development, commitment tracking, CAPA closure, and effectiveness verification. Coordinate SMEs and cross-functional support.
Oversee accurate and timely preparation, review, approval, and customer delivery of APQRs/PQRs, including evaluation of product, process, investigation, complaint, and CAPA trends.
Support development and maintenance of Quality Agreements and ensure customer notifications, responsibilities, deliverables, and commitments are clearly assigned and fulfilled.
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.
Use metrics, lessons learned, risk assessments, and customer feedback to improve right-first-time performance, cycle times, investigation quality, and customer experience.
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 culture.