Senior QA Manager, Customer Focus & Project Assurance

Piramal Pharma•Sellersville, PA

11d

About The Position

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO) that provides comprehensive development and manufacturing solutions throughout the drug lifecycle. They operate a global network of facilities across North America, Europe, and Asia, offering services such as Drug Discovery Solutions, Process & Pharmaceutical Development, Clinical Trial Supplies, and Commercial supply of APIs and Finished dosage forms. They also specialize in Highly Potent APIs and Antibody Drug Conjugation, serving both Innovator and Generic companies worldwide. The Senior QA Manager, Customer Quality & Project Assurance role is crucial for leading customer-facing Quality activities and ensuring the timely delivery of Quality objectives across various stages of product development and manufacturing within the CDMO setting. This position acts as the main Quality partner for Project Management, collaborating with multiple departments including Manufacturing, Quality Control, Regulatory Affairs, Technical Services, Validation, and Supply Chain to meet customer expectations and maintain cGMP compliance. The role is designed to be the primary Quality liaison for customer programs, overseeing customer-facing Quality operations, project quality execution, customer audits, complaints, investigations, Annual Product Quality Reviews (APQRs), batch disposition support, and ultimately, customer satisfaction. It also offers a clear career progression path within the expanding CDMO business.

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.
Experience with electronic Quality systems such as TrackWise, MasterControl, Veeva, SAP, or comparable platforms is preferred.

Responsibilities

Oversee approximately 4–6 Quality professionals.
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.
Serve as the Quality leadership designee as needed.
Serve as the primary Quality contact for assigned customers, building trusted relationships, leading routine Quality reviews and escalations, and ensuring 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, ensuring investigations are scientifically sound, risk-based, and completed within approved timelines.
Lead complaint intake, investigation, response, trend review, and escalation, ensuring 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, coordinating 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, setting priorities and performance expectations, allocating work, building capability, and fostering accountability, collaboration, engagement, and a strong Quality culture.