Summary

PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical supply chain solutions to pharmaceutical and biopharmaceutical companies worldwide. Founded in 1991 and headquartered in Philadelphia, Pennsylvania, the company has established itself as a trusted partner in the healthcare industry, offering integrated services that span the entire drug development lifecycle. PCI specializes in drug development support, clinical trial supply management, contract drug manufacturing, sterile and non-sterile drug product packaging, and global pharmaceutical logistics. With a global footprint encompassing 30 GMP-compliant facilities across multiple continents, the company serves as a strategic partner that follows the molecule from early development through commercial launch. PCI's expertise enables clients to accelerate time-to-market while ensuring regulatory compliance and quality standards. The company's comprehensive service portfolio includes analytical services, formulation development, commercial manufacturing, packaging, supply chain management, and distribution, making it a one-stop solution for pharmaceutical companies seeking to outsource their development and manufacturing needs.

Job description

Essential Duties and Responsibilities

Build, coach, and scale a high-performing, site-wide QA-VI organization, establishing clear performance expectations, talent development pathways, and succession planning aligned with site and corporate strategic initiatives.
Manage departmental resources, operational workflows, and capital/operational planning to support continuous growth and site expansion.
Champion the strategic growth and modernization of the Visual Inspection program. Lead the validation and implementation roadmap for advanced technologies, including automated visual inspection (AVI) equipment.
Continually evaluate defect categories, classification systems, rates, and associated action/alert limits to ensure alignment with industry standards and pharmacopeial requirements.
Spearhead campus-wide harmonization efforts related to QA-VI activities across the Bedford, NH facility, driving operational excellence, standardization, and process efficiency.
Partner with cross-functional leadership to optimize final product inspection, AQL strategies, management of qualification kits, defect library maintenance, and final product retain inspection programs.
Provide expert quality oversight and sign-off for complex Quality System events, including major investigations, critical deviations, and high-impact CAPAs.
Ensure robust compliance with cGMP regulations, internal policies, and evolving global regulatory expectations. Maintain audit-readiness across all QA-VI functions.
Develop, monitor, evaluate, and present advanced Quality metrics and trends associated with QA-VI to site and corporate Senior Management.
Proactively identify, assess, and escalate product quality risks and observations, driving risk-mitigation strategies to protect product safety and supply continuity.
Serve as a primary SME and host for client audits and regulatory inspections (FDA, Health Authorities) concerning visual inspection, defect management, and product disposition.
Ensure training programs are robust, dynamically updated, and that all staff maintain flawless qualification standing. Foster a culture of quality compliance, transparency, and data integrity.
Guide personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices.

Qualifications

Bachelor’s Degree in relevant scientific discipline. Minimum 10 years’ experience in GMP pharmaceutical or biotech industry, with 5+ years of experience in a Quality based role supporting clinical and/or commercial production, or equivalent combination of education and experience.
Prior management experience in manufacturing, visual inspection, labeling/packaging, or Quality Assurance/Quality Control of sterile drug product is required.
Strong understanding of regulatory visual inspection compendium and pharmacopeial standards, defect characterization.
Strong technical writing skills to support investigations and risk assessments.
Exceptional organizational skills and attention to detail.
Ability to make risk-based decisions and resolve issues with minimal guidance.
Excellent interpersonal skills and the ability to communicate well orally and in writing.
Proficiency in MS Office including Word, and Excel.
Excellent verbal and written communication skills required.

Requirements

Bachelor’s Degree in relevant scientific discipline
Minimum 10 years’ experience in GMP pharmaceutical or biotech industry
5+ years of experience in a Quality based role supporting clinical and/or commercial production
Prior management experience in manufacturing, visual inspection, labeling/packaging, or QA/QC of sterile drug product
Strong understanding of regulatory visual inspection compendium and pharmacopeial standards, defect characterization
Strong technical writing skills to support investigations and risk assessments
Exceptional organizational skills and attention to detail
Ability to make risk-based decisions and resolve issues with minimal guidance
Excellent interpersonal skills and the ability to communicate well orally and in writing
Proficiency in MS Office including Word, and Excel
Excellent verbal and written communication skills

Company overview

PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical supply chain solutions to pharmaceutical and biopharmaceutical companies worldwide. Founded in 1991 and headquartered in Philadelphia, Pennsylvania, the company has established itself as a trusted partner in the healthcare industry, offering integrated services that span the entire drug development lifecycle. PCI specializes in drug development support, clinical trial supply management, contract drug manufacturing, sterile and non-sterile drug product packaging, and global pharmaceutical logistics. With a global footprint encompassing 30 GMP-compliant facilities across multiple continents, the company serves as a strategic partner that follows the molecule from early development through commercial launch. PCI's expertise enables clients to accelerate time-to-market while ensuring regulatory compliance and quality standards. The company's comprehensive service portfolio includes analytical services, formulation development, commercial manufacturing, packaging, supply chain management, and distribution, making it a one-stop solution for pharmaceutical companies seeking to outsource their development and manufacturing needs.