Associate Director, QA Operations – Visual Inspection

PCI Pharma Services•Bedford, NH

1d•Onsite

About The Position

The Associate Director, QA Operations – Visual Inspection leads and develops a site-wide Quality Assurance Visual Inspection (QA-VI) organization, including setting performance expectations, developing talent, and succession planning aligned with site and corporate priorities. The role manages departmental resources, workflows, and capital and operational planning to support growth and site expansion. This position leads the strategic growth and modernization of the Visual Inspection program, including validation and implementation of advanced technologies such as automated visual inspection equipment. It evaluates defect categories, classification systems, rates, and action and alert limits against industry and pharmacopeial requirements, and drives QA-VI harmonization across PCI’s Bedford, New Hampshire facility. The role partners with cross-functional leaders on final product inspection, AQL strategies, qualification kits, defect libraries, and final product retain inspection programs. It provides quality oversight and sign-off for complex quality-system events, maintains cGMP compliance and audit readiness, develops and presents QA-VI quality metrics to senior management, and proactively manages product-quality risks. The Associate Director serves as a subject matter expert and host for client audits and regulatory inspections related to visual inspection, defect management, and product disposition. The role also ensures effective training and qualification programs and guides personnel in GMP operations, compliance, and industry best practices.

Requirements

Bachelor’s degree in a relevant scientific discipline.
At least 10 years of experience in the GMP pharmaceutical or biotechnology industry, with at least 5 years in a Quality role supporting clinical and/or commercial production, or an equivalent combination of education and experience.
Prior management experience in manufacturing, visual inspection, labeling/packaging, or Quality Assurance/Quality Control of sterile drug product.
Strong understanding of regulatory visual inspection compendia, pharmacopeial standards, and defect characterization.
Strong technical writing skills for 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 oral and written communication skills.
Proficiency in Microsoft Office, including Word and Excel.
Ability to lead a site-based team and manage other managers.
Ability to work independently with minimal supervision, adapt to operational and organizational change, and manage competing demands in a complex environment.
Ability to coach, train, and mentor others; communicate technical subject matter; and interpret local SOPs and regulatory guidance.
Ability to lift, carry, push, or pull weights up to 20 pounds.

Responsibilities

Build, coach, and scale a site-wide QA-VI organization; establish performance expectations, talent-development pathways, and succession plans.
Manage departmental resources, workflows, and capital and operational planning to support growth and site expansion.
Lead modernization of the Visual Inspection program, including validation and implementation of advanced technologies such as automated visual inspection equipment.
Evaluate defect categories, classification systems, rates, and action and alert limits for alignment with industry and pharmacopeial standards.
Lead QA-VI harmonization across the Bedford, NH facility to promote operational excellence, standardization, and process efficiency.
Partner with cross-functional leaders to optimize final product inspection, AQL strategies, qualification kits, defect-library maintenance, and final product retain inspection programs.
Provide quality oversight and sign-off for complex quality-system events, including major investigations, critical deviations, and high-impact CAPAs.
Ensure compliance with cGMP regulations, internal policies, and global regulatory expectations, and maintain audit readiness across QA-VI functions.
Develop, monitor, evaluate, and present QA-VI quality metrics and trends to site and corporate senior management.
Identify, assess, and escalate product-quality risks and observations; drive risk-mitigation strategies to protect product safety and supply continuity.
Serve as a subject matter expert and host for client audits and regulatory inspections concerning visual inspection, defect management, and product disposition.
Maintain robust, current training programs and staff qualification standing; foster quality compliance, transparency, and data integrity.
Guide personnel involved in GMP operations on cGMP compliance, internal procedures, regulatory requirements, and industry best practices.
Provide hands-on leadership, coaching, and coordination of actions; manage and support multiple projects and priorities.
Travel frequently between local Bedford, NH facilities.
Support senior management as needed.