Director of Quality Assurance

This is a fully remote position, open to applicants in Maryland, +3 more states.

📋 Description

• Develop, implement, and enhance a Quality Management System (QMS) tailored for government operations.

• Create and uphold quality policies, procedures, governance frameworks, and documentation standards throughout government activities.

• Formulate site and program quality plans that meet customer needs, contractual obligations, and operational risks.

• Spearhead change-control and continuous improvement initiatives.

• Design quality metrics, reporting systems, and management review processes.

• Lead and nurture quality teams across various locations.

• Ensure consistent quality execution and empower local teams.

• Identify persistent issues, facilitate root-cause analysis, and ensure prompt corrective actions are taken.

• Implement quality controls for receiving, storage, inventory management, fulfillment, shipping, and transportation.

• Supervise inventory accuracy, product integrity, chain of custody, and management of customer-owned inventory.

• Investigate operational quality issues, customer complaints, inventory discrepancies, deviations, nonconformances, excursions, and service failures.

• Manage CAPA programs and verify their effectiveness.

• Oversee quality standards for ambient, refrigerated, frozen, and ultra-cold storage environments.

• Direct temperature mapping, environmental monitoring, equipment qualification, calibration, and requalification activities.

• Conduct internal audits and assist with customer, government, and external audits, inspections, and certifications.

• Maintain audit records, corrective action documentation, and controlled quality system records.

• Manage supplier qualification and approved supplier programs.

• Evaluate quality implications of new sites, equipment, technologies, and process modifications.

• Review WMS enhancements and operational modifications for validation, compliance, and quality system impacts.

• Ensure all necessary training is completed and documented prior to implementing new processes or systems.

• Represent the Quality department in customer meetings, audits, inspections, and government evaluations.

• Communicate quality performance, risks, investigations, and corrective action progress to customers and government stakeholders.

• Convert customer and contractual requirements into sustainable operating procedures and quality controls.

• Provide executive reporting and contribute to strategic planning.

• Travel up to 50% for site support, audits, investigations, implementations, and customer interactions.

⛳️ Requirements

• 8+ years of relevant experience in quality assurance, quality systems, regulatory compliance, supplier quality, distribution quality, operational quality, or similar fields.

• 3+ years of experience in personnel management or leading a quality function, program, or multi-site quality initiative.

• Proficient in designing, implementing, maintaining, and continuously improving Quality Management Systems (QMS), including audits, investigations, CAPA, change control, document control, training, quality metrics, and ISO 9001-aligned practices.

• Demonstrated experience leading quality programs in warehouse, distribution, logistics, cold-chain, or temperature-controlled operations within cGMP-regulated, pharmaceutical, healthcare, government, or similarly demanding environments.

• Familiarity with temperature mapping, equipment qualification, calibration, environmental monitoring, alarm management, and temperature excursion investigations.

• Experience in supporting supplier quality, operational change control, system validation, and quality assessments for process, equipment, or technology changes.

• Proven ability to present quality metrics, audit results, investigation findings, program risks, and corrective action plans to leadership, customers, auditors, or government stakeholders.

• Capability to translate customer, contractual, regulatory, and quality requirements into practical operating procedures.

• Strong communication, presentation, stakeholder management, and problem-solving skills at an executive level.

• Bachelor’s degree in Quality Management, Supply Chain, Logistics, Engineering, Life Sciences, Business, or a related field, or an equivalent combination of education, certifications, relevant military experience, and applicable practical experience.

• Ability to obtain and sustain the necessary security clearance for supported programs.

• Willingness and capability to travel up to 50%.

• Must be available to assist with critical quality incidents and participate in warehouse walkthroughs and site assessments.

• Applicants must meet citizenship, site access, suitability, background investigation, and security requirements specific to the contract.

• Must be a U.S. citizen.

• Preferred qualifications include hands-on cGMP experience; experience with federal logistics or government contracting; validation and qualification expertise; ASQ certification; Lean Six Sigma or continuous improvement certification; a Master’s degree; and an active Secret Security Clearance.

🏝️ Benefits

• Full-time employment.

• Travel support for necessary business travel up to 50%.

• Equal opportunity employer committed to fostering diversity and inclusion.

• Reasonable accommodations available during the application or interview process.