PCI Pharma Services

PCI Pharma Services

Quality Manager, NPI

Philadelphia, PA, USA

Sponsorship not specifiedDetected 26 days ago
ComplianceProcess ImprovementERPPerformance ManagementGMPFDA RegulatoryMedical DevicesCommunicationCollaborationProblem SolvingCritical ThinkingTime ManagementWritingMicrosoft OfficeLean Manufacturing

About the role

  • Bridge to thousands of biopharma companies and their patients.
  • Supervisory Responsibilities: This role has the potential to supervise up to five Quality team members, with both direct and matrix (dotted-line) supervisory responsibilities, in accordance with organizational policies and applicable laws.
  • Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.

Responsibilities

  • Manage quality deliverables and timelines in alignment with project milestones to support on-time, compliant product launches.
  • Support equipment qualification, packaging line readiness, and process validation activities to ensure operational readiness for commercial production.
  • Provide Quality support for new equipment introduction, ensuring process capabilities are built in by design, and align UAT and FAT activities with Quality and regulatory expectations in collaboration with Validation, cross-functional teams, and equipment vendors.
  • Lead Quality review of batch records and associated documentation and ensure appropriate GMP and product-specific training.
  • Collaborate with internal teams and clients to define and report on key performance indicators (KPIs) for NPI programs.
  • Participate in client meetings, quality reviews, and support regulatory inspections.
  • Ensure smooth transition from development/NPI into routine manufacturing, including support of PPQ, initial commercial campaigns, and launch readiness.
  • Lead the development and execution of quality strategies to support successful onboarding of new products, ensuring alignment with NPI program, validation and regulatory requirements.
  • Serve as the primary Quality representative on cross-functional NPI teams, ensuring quality requirements are defined and integrated across all project phases (design transfer, process development, and validation).
  • Manage day to day activities of quality team members in relation to NPI projects

Requirements

  • The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position.
  • Critical thinking skills along with a strong collaborative approach is required.
  • The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Required:
  • Minimum of 5 years of experience in a regulated industry, preferably in medical devices or combination products and experience in contract manufacturing, ideally within the pharmaceutical sector.
  • Proven ability to manage and maintain strong client relationships, ensuring alignment on project timelines, quality deliverables, and compliance expectations.
  • Strong organizational, communication, and problem-solving skills are essential to successfully manage competing priorities and support project milestones.
  • Strong analytical skills with the ability to lead complex investigations and drive effective corrective and preventive actions (CAPAs).
  • Demonstrated ability to lead teams, mentor staff, and drive organizational goals.

Nice to have

  • Bachelor's degree in science, Engineering, Quality, or a related field.
  • Experience with packaging line optimization, process characterization, and continuous improvement.
  • Familiarity with equipment commissioning, qualification, and validation processes
  • Demonstrated expertise in technical writing, root cause analysis (RCA), and problem-solving methodologies.
  • In-depth knowledge of regulatory compliance requirements (e.g., FDA, ISO, ICH) and manufacturing quality systems.
  • Experience with continuous improvement methodologies such as Lean and Six Sigma.
  • Proficiency in ERP and electronic Quality Management Systems (eQMS).
  • Skilled in Microsoft Office and technical software tools.

Company info

  • Together, delivering life-changing therapies.
  • We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level.
  • We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.

Equal opportunity

  • PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer.
  • We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Visa & Work Authorization

  • We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual o
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This listing is sourced directly from PCI Pharma Services's careers page and normalized into a canonical job model.