Quality Lead

Granules•Suffolk, VA

About The Position

The Quality Lead supports compliance with cGMP, company policies and procedures, and applicable regulatory requirements. This individual-contributor role oversees and supports quality activities involving documentation, inspections, material and product review and release, deviations, CAPAs, change controls, audits, SOPs, and continuous improvement. The position helps maintain effective Quality Management Systems and an inspection-ready environment, with room to grow into a people management role. The role supports quality operations across pharmaceutical distribution and warehouse activities, as well as work with contract manufacturers. It provides training and cross-functional guidance on quality systems, documentation, and regulatory requirements, and partners with internal and external stakeholders to address quality issues and complete quality activities. Work may include weekends or off-hours as business needs require, and approximately 10% travel.

Requirements

Strong knowledge of cGMP/GxP, FDA requirements, Title 21 of the Code of Federal Regulations and Compendia, Good Documentation Practices, and applicable pharmaceutical regulatory requirements.
Knowledge of QMS processes, including deviations and investigations, CAPAs, change controls, complaints, audits, and controlled document management.
Knowledge of quality management in pharmaceutical warehouse operations and with contract manufacturers.
Proficiency with QMS/EDMS platforms, such as TrackWise or Veeva, and Microsoft Office applications; ability to manage electronic and hardcopy quality records.
Strong analytical, organizational, technical writing, and communication skills; excellent attention to detail and 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.
Bachelor's degree in Life Sciences, Regulatory Affairs, Document Control, or a related field, or equivalent work experience.
Minimum of 5 years in the pharmaceutical industry.
Experience with regulatory body audits and/or exposure to audit visits.
Experience related to distribution quality operations for pharmaceutical products.
Experience related to managing contract manufacturers.
Ability to lift 10–15 lbs and to sit and stand for extended periods while reviewing or processing documentation.
Availability to work weekends or off-hours as business needs require.

Responsibilities

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, 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 the Quality Management System, 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 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 and component control, inventory-related quality activities, and issue resolution.
Support audits, inspections, vendor qualifications, validation, Annual Product Quality Reviews (APQRs), and other quality and 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.
Maintain knowledge of pharmaceutical serialization requirements, as applicable.
Work weekends or off-hours as business needs require.
Perform other duties as assigned.