Bachelor's Degree in a relevant scientific discipline.
Minimum 10 years' experience in GMP pharmaceutical or biotech industry.
5+ years in a Quality role supporting clinical/commercial production.
Prior management experience in manufacturing or Quality Assurance/Quality Control.
Strong understanding of regulatory visual inspection standards and defect characterization.
Exceptional organizational skills and attention to detail.
Proficiency in MS Office, particularly Word and Excel.
Responsibilities
Build and scale a high-performing QA-VI organization with clear performance expectations.
Manage departmental resources and operational workflows for growth and expansion.
Lead the modernization of the Visual Inspection program with advanced technologies.
Evaluate defect categories and ensure alignment with industry standards.
Drive harmonization of QA-VI activities across the facility for operational excellence.
Partner with leadership to optimize inspection strategies and defect management.
Provide quality oversight for major investigations and critical deviations.
Benefits
Opportunity to lead and develop a high-performing team.
Engagement in cutting-edge technology implementation.
Collaboration with cross-functional leadership.
Focus on continuous growth and site expansion.
Dynamic work environment with opportunities for professional development.
Full Job Description
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 representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires the ability to lift, carry, push or pull light weights (up to 20 pounds)
Frequent reading, writing, and verbal communication
Able to translate ideas to actual concepts and processes
Proven ability to manage multiple projects (duties) simultaneously
Able to work in a highly complex environment with competing demands and priorities
Ability to observe, identify potential issues, and resolve satisfactorily.
Ability to provide hands on leadership, coaching, and coordination of needed actions with a focus on achieving goals and deliverables. Must be able to manage, plan and multi-task with minimal guidance.
Support senior management as needed.
Frequent travel between local Bedford, NH facilities.
Qualifications: 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.
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
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
