Senior Quality Assurance Manager

Piramal Pharma Solutions; Sellersville (Bucks County); On-site; USD 120,000 - 180,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior QA Manager, Customer Quality & Project Assurance to lead customer-facing Quality activities and ensure on-time delivery of Quality deliverables across development, validation, and manufacturing. You will partner with Project Management and cross-functional teams to meet commitments while ensuring cGMP compliance.

The role oversees batch disposition, investigations, complaints, CAPAs, APQRs/PQRs, and customer audits, driving continuous improvement and

Qualifications

• Bachelor's degree in a relevant science field required; advanced degree preferred.
• 8+ years QA in pharma/regulated life sciences, with cGMP manufacturing experience.
• 3+ years of direct people leadership experience in a QA environment.
• CDMO/CMO experience supporting multiple customers and products preferred.
• Strong working knowledge of regulatory requirements (FDA/EMA/ICH) and data integrity.

Responsibilities

• Lead customer quality leadership and routine quality reviews with assigned customers.
• Partner with Project Management to define, prioritize, and track quality activities.
• Coordinate timely QA review of batch records, test results, deviations, investigations, and disposition.
• Oversee deviations, investigations, OOS/OOT events, complaints, CAPAs, and APQRs/PQRs.
• Lead customer audits, maintenance of commitments, and CAPA closure with cross-functional support.
• Maintain dashboards for release cycles, events, CAPA, audits, and customer commitments.

Skills

Customer Quality Leadership

Project Quality Execution

Batch Release

Investigations & CAPA

Customer Audits

Quality Metrics & KPIs

People Leadership

Regulatory Knowledge

Quality Agreements

Continuous Improvement

Education

Bachelor's degree in Chemistry/Biology/Pharma

Advanced degree preferred

CDMO/CMO experience

Tools

TrackWise

MasterControl

Veeva

SAP

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.

• 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.

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 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 culture.

EDUCATION / EXPERIENCE

• Education: Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, Life Sciences, or a related scientific discipline is required. An advanced degree is preferred.
• Industry Experience: Minimum eight (8) years of Quality Assurance experience in pharmaceutical, biotechnology, or regulated life sciences, including work in a cGMP manufacturing environment.
• Leadership Experience: Minimum three (3) years of direct people‑leadership experience, including responsibility for workload planning, coaching, development, and performance management.
• CDMO Experience: Experience supporting multiple customers and products in a CDMO/CMO environment is strongly preferred.
• Customer and Project Quality: Demonstrated experience managing customer‑facing Quality activities and partnering with Project Management and cross‑functional teams to meet project milestones.
• Quality Operations: Experience with batch disposition, deviations, investigations, OOS/OOT events, complaints, CAPAs, APQRs/PQRs, change controls, customer audits, and Quality Agreements.
• Regulatory Knowledge: Strong working knowledge of 21 CFR Parts 210 and 211, EU GMP, ICH guidance, data integrity expectations, and risk‑based Quality decision‑making.
• Systems: Experience with electronic Quality systems such as TrackWise, MasterControl, Veeva, SAP, or comparable platforms is preferred.

JOB COMPETENCIES

• 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.