Quality Lead

Quality Lead

The Quality Lead supports compliance with cGMP, company policies, procedures, and applicable regulatory requirements. This role oversees and supports quality activities including documentation, inspections, material and product review/release, deviations, CAPAs, change controls, audits, SOPs, and continuous improvement initiatives. The position helps maintain effective Quality Management Systems and a compliant, inspection-ready environment.

This is an individual contributor role with room to grow into a people management role.

Job Duties & Responsibilities Include But Not Limited To:

• Manage the lifecycle of controlled GMP documents, including issuance, revision, version control, retention, and archival.
• Author, review, and maintain SOPs, protocols, reports, batch records, forms, and other quality documents for accuracy and compliance.
• Maintain QA databases, document repositories, and tracking systems in an accurate and inspection-ready state.
• Track and review controlled documents, logbooks, change requests, and required records for timely completion.
• Ensure compliance with cGMP, DEA, SOPs, quality standards, and applicable regulatory requirements.
• Manage and support Quality Management System (QMS), including deviations, CAPAs, change controls, complaints, investigations, and timely record closure.
• Coordinate and assess investigations, non-conformances, and customer complaints to identify root causes, evaluate quality and operational impact, and support appropriate corrective actions.
• Perform or support inspections, sampling, shipment review, and material disposition, as applicable.
• Support warehouse and distribution quality activities, including records and logbook reviews, environmental monitoring, material/component control, inventory-related quality activities, and issue resolution.
• Support audits, inspections, vendor qualifications, validation, Annual Product Quality Reviews (APQRs), and other quality/compliance programs.
• Identify and escalate quality or compliance risks, support continuous improvement, and maintain an inspection-ready environment.
• Support GMP and quality training, including assignments, tracking, and training records.
• Provide new hire training on DEA, GMPs, Safety, Pharmacovigilance, and other requirements.
• Reinforce employee understanding of SOPs, quality procedures, and compliance requirements.
• Partner with internal and external stakeholders to resolve quality issues and ensure timely completion of quality activities.
• Collaborate on investigations, change controls, validation, and other quality initiatives.
• Provide cross-functional guidance on quality systems, documentation, and regulatory requirements.

Additional Responsibilities:

• Maintain knowledge of pharmaceutical serialization requirements, as applicable.
• Work weekends or off-hours as business needs require.
• Perform other duties as assigned.

Reports To:

Primary (direct manager): Site Head, QA (Chantilly)

Secondary (on-site): Site Head, Distribution (Suffolk)

Internal/External Contacts:

Internal Contacts: Quality Assurance, Operations, HR, Supply Chain/Warehouse, IT/Systems

External Contacts: Regulatory Inspectors and Auditors, Contract Manufacturers and packagers

Requirements:

Knowledge & Skills:

• Strong knowledge of cGMP/GxP, FDA, Title 21 of the Code of Federal Regulations and Compendia, Good Documentation Practices, and applicable pharmaceutical regulatory requirements.
• Knowledge of QMS processes, including deviations/investigations, CAPAs, change controls, complaints, audits, and controlled document management.
• Knowledge of working in Quality management related to pharmaceutical warehouse management and contract manufacturers.
• Proficiency with QMS/EDMS platforms (e.g., TrackWise, Veeva) and Microsoft Office applications, with the ability to effectively manage electronic and hardcopy quality records.
• Strong analytical, organizational, technical writing, and communication skills, with excellent attention to detail and the ability to collaborate across teams.
• Ability to manage competing priorities, adapt to change, and independently resolve issues while maintaining compliance.
• Ability to work independently and collaboratively on complex assignments.

Experience & Education:

• Bachelor's degree in Life Sciences, Regulatory Affairs, Document Control, or related field (or equivalent work experience) with a minimum of 5 years in the pharmaceutical industry.
• Experience with regulatory body audit experience and/or exposure to audit visits.
• Experience related to distribution quality operations related to pharmaceutical products
• Experience related to managing contract manufacturers

Physical Requirements/Working Environment:

• Primarily office-based role with routine use of a computer, keyboard, and standard office equipment.
• Light to moderate lifting up to 10-15 lbs is required.
• Ability to sit and stand for extended periods while reviewing or processing documentation

Travel:

Approximately 10%

Disclaimer:

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

We believe in fair and transparent pay practices. Actual compensation is determined based on relevant experience, qualifications, skills, and internal equity.