Head of Quality

Texcell•Frederick, MD

16h•$120,000

About The Position

The Head of Quality leads the organization’s quality strategy, quality systems, and compliance programs across GLP- and cGMP-regulated activities. This role provides strategic and operational leadership to build, maintain, and continuously improve a scalable, inspection-ready quality framework that supports growth, innovation, operational excellence, and regulatory compliance.

Requirements

Bachelor’s degree in Life Sciences, Chemistry, Biology, Pharmacy, Engineering, or related discipline required.
8+ years of progressive experience in cGMP and GLP quality management
3+ years of leadership experience in regulated environments.
Strong knowledge of cGMP, GLP, ICH, FDA, and 21 CFR Part 11 requirements.
Hands-on experience with QMS processes, including deviations, CAPAs, change control, OOS/OOT investigations, complaints, document control, and training systems.
Experience writing, reviewing, and approving SOPs and other quality documentation.
Knowledge of validation requirements for facilities, equipment, processes, and computerized systems.
Experience with vendor qualification, auditing, and quality agreement management.
Strong leadership, collaboration, and influencing skills in cross-functional environments.
Excellent written and verbal communication skills.
Strong analytical, problem-solving, and root cause investigation skills.
Ability to identify risks, anticipate issues, and implement practical solutions.
Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
Proficiency with standard business software and quality systems tools.

Responsibilities

Develop and execute the company’s quality strategy in alignment with business objectives and regulatory requirements.
Promote a culture of quality, compliance, accountability, and continuous improvement across the organization.
Lead the design, implementation, maintenance, and improvement of the Quality Management System (QMS), including document control, training, change control, deviations, CAPAs, complaints, risk management, and audit/inspection management.
Ensure compliance with applicable cGMP, cGLP, ICH, FDA, and 21 CFR Part 11 requirements.
Provide quality oversight for internal operations and outsourced GxP activities, including manufacturing, testing, and other regulated services.
Serve as the Quality representative on cross-functional teams and provide oversight of quality activities performed by external manufacturing and testing partners.
Review and approve GMP- and GLP-related documentation, including SOPs, batch records, specifications, master manufacturing records, analytical methods, labeling, validation documents, study protocols, and reports.
Lead validation activities for facilities, equipment, processes, utilities, and computerized systems, including oversight and approval of computer system validation documentation.
Ensure IQ/OQ/PQ, validation, training, and other quality records are maintained in a complete, accurate, and inspection-ready manner.
Develop and implement risk management processes, including trending, analysis, reporting, and follow-through on improvement actions.
Lead investigations, root cause analyses, and CAPA activities to address quality events and prevent recurrence.
Lead the vendor quality program, including qualification, audit scheduling, vendor audits, performance monitoring, and quality agreements.
Support and represent Quality during internal audits, client audits, regulatory inspections, and due diligence activities.
Conduct internal facility inspections and help maintain audit logs, study QA files, and master quality schedules.
Communicate quality expectations clearly and effectively across functions and levels of the organization.
Perform additional quality and compliance responsibilities as needed.