Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
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
Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
Ability to lead a site-based team
Ability to manage other managers (direct reports)
Honesty, integrity, respect and courtesy with all colleagues
Creative with the ability to work with minimal supervision and balanced with independent thinking
Resilient through operational and organizational change
Ability to coach, train, and mentor others
Cross functional staff, members of management, internal and external clients, members of the Quality organization
Able to communicate effectively and tactfully
Able to articulate and comprehend technical subject matter
Able to comprehend, interpret, and articulate instructions set forth in local SOPs and regulatory guidance.
Work Environment: The work environment characteristics described here are…