Senior Quality Assurance Customer & Project Lead

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 90,000 - 130,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Quality Assurance Specialist to lead customer-facing quality activities in a CDMO environment. You will oversee batch release support, investigations, CAPAs, audits, and cross-functional coordination to ensure cGMP compliance.

In this role you will partner with Project Management, Manufacturing, Regulatory Affairs and Quality Control to meet commitments, maintain data integrity, and drive continuous improvement across programs.

Qualifications

• Bachelor’s degree in a scientific discipline is required.
• Minimum five years of QA experience in pharma/regulated life sciences.
• Experience with CDMO/CMO settings preferred.
• Proven ability to manage customer-facing quality activities.

Responsibilities

• Serve as day-to-day Quality contact for customers and programs.
• Plan, track, and complete Quality activities aligned with project milestones.
• Review batch records and disposition documentation for release.
• Coordinate audits, investigations, CAPAs, and customer communications.

Skills

Quality Assurance

Customer-facing

Project Management

Education

Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, Life Sciences, or related

Tools

TrackWise

MasterControl

Veeva

SAP

Job description

Job Title Senior Quality Assurance Specialist

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 : www.piramalpharmasolutions.com

Job Description

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.

KEY ACCOUNTABILITIES

• 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, compliant, and issued within established commitments.
• CAPA Management: Develop, review, and track CAPAs to ensure alignment with root cause, assignment of accountable owners and milestones, timely completion, adequate objective evidence, and meaningful effectiveness checks.
• Customer Audits: Coordinate audit planning and readiness activities; assemble requested documents; manage audit logistics and action logs; support audit execution; draft or coordinate responses; and track commitments, CAPAs, and effectiveness verification to closure.
• Annual Product Quality Reviews: Prepare, coordinate, review, and route APQRs/PQRs for approval and customer delivery. Compile and evaluate product, process, deviation, investigation, complaint, change, and CAPA data to identify meaningful trends and required actions.
• Quality Agreements and Customer Commitments: Support the development, review, maintenance, and implementation of quality agreements. Track customer notifications, responsibilities, deliverables, and commitments and coordinate timely completion with responsible functions.
• Risk, Metrics and Escalation: Maintain accurate dashboards and trackers for release cycle time, quality event closure, CAPAs, complaints, audits, APQRs/PQRs, and customer commitments. Analyze status, identify emerging risks, recommend recovery actions, and elevate significant issues.
• Cross-Functional Coordination: Work with Manufacturing, Quality Control, Technical Services, Validation, Regulatory Affairs, Supply Chain, Project Management, and other functions to resolve Quality issues, align priorities, obtain required inputs, and meet program milestones.
• Continuous Improvement: Use metrics, lessons learned, risk assessments, recurring issue trends, and customer feedback to recommend and implement improvements in right-first-time performance, cycle time, investigation quality, documentation, and customer experience.
• Documentation and Data Integrity: Create and maintain complete, accurate, contemporaneous, attributable, and traceable records in approved systems. Ensure controlled documents, correspondence trackers, and evidence packages are inspection-ready and compliant with data integrity expectations.
• Inspection and Regulatory Support: Support regulatory inspections, internal audits, and corporate assessments by preparing records, responding to requests, coordinating subject-matter inputs, documenting commitments, and tracking assigned actions to closure.
• Workload Ownership: Independently manage multiple customer and product priorities, communicate constraints early, meet agreed deadlines and provide transparent status updates. Seek timely decisions when priorities conflict or commitments are at risk.
• Quality Culture: Demonstrate accountability, sound quality judgment, respectful challenge, proactive communication, and patient- and product-focused compliance mindset. Share knowledge and support onboarding or peer training as assigned.

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 five (5) years of Quality Assurance experience in pharmaceutical, biotechnology, or regulated life sciences, including work in a cGMP manufacturing environment.
• CDMO Experience: Experience supporting multiple customers, products, and concurrent project deliverables in a CDMO/CMO environment is strongly preferred.
• Customer and Project Quality: Demonstrated experience supporting customer-facing Quality activities and partnering with Project Management and cross-functional teams to meet project milestones.
• Quality Operations: Hands-on experience with several of the following: batch disposition, deviations, investigations, OOS/OOT events, complaints, CAPAs, APQRs/PQRs, change controls, customer audits, and Quality Agreements.
• Regulatory Knowledge: 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

• Strong individual ownership, organization, prioritization, and follow-through across multiple concurrent commitments.
• Customer-focused communication with sound, independent Quality judgment and appropriate escalation.
• Excellent written, verbal, presentation, and stakeholder-management skills.
• Demonstrated investigation, root cause analysis, problem solving, technical writing, and risk assessment capability.
• Ability to influence without direct authority, coordinate cross-functional contributors, and hold action owners accountable for timely execution.
• Ability to balance patient and product protection, regulatory compliance, customer commitments, and business continuity.
• Proficiency in preparing clear dashboards, status reports, customer correspondence, and inspection-ready documentation.
• Ability to work effectively in a changing, deadline-driven CDMO environment while maintaining accuracy and compliance.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

• Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions.
• Extended periods of sitting, walking, typing, computer use, virtual meetings, and document review may required.
• Work may include limited exposure to manufacturing places, laboratory, and warehouse environment.
• Required personal protective equipment may include safety glasses, lab coats, gloves, specialized clothing and appropriate footwear.
• Occasional lifting, bending, stooping, squatting, pushing, or pulling may need.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the-counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group. PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.