Manager, Quality Systems

The Manager, Quality Systems is an on‑site, Monday‑Friday role responsible for developing, implementing, and maintaining quality systems across the organization. This includes change control, deviations/investigations/OOS, corrective and preventive action (CAPA), document management, record retention, training management, product quality complaints, quality metrics, management review, internal audit programs, and support for regulatory inspections and submissions.

Responsibilities

• Lead development, implementation, and continuous improvement of all quality systems.
• Maintain document management systems for creation, approval, issuance, control, and storage of GxP documents, coordinating with third parties as needed.
• Assist in establishing and delivering training and continuing‑education programs on quality assurance and GxP requirements.
• Coordinate and prepare Management Review Meetings, collect key quality and compliance metrics, and present monthly quality updates.
• Set up business tools and processes to capture quality‑related data for efficient reporting.
• Manage deviation, investigation, and product quality complaint programs.
• Oversee change control and CAPA processes, lead teams, monitor performance, and report progress.
• Manage the Internal Audit program: schedule audits, conduct them, support investigation of findings, and approve responses.
• Support investigation and documentation of all product quality complaints and liaise with Medical Affairs and contract pharmacovigilance providers.
• Recommend changes and process improvements to sustain compliance and operational efficiency.
• Coordinate and prepare Quality Review Board meetings, including document preparation, attendance, minute taking, and follow‑up.
• Serve as interface to third‑party organizations and regulatory agencies during audits and inspections.
• Support audits and regulatory inspections, respond to findings, and manage follow‑up actions.
• Participate in educational programs related to pharmaceutical quality assurance and regulatory compliance.
• Assist in revising, improving, and developing programs, policies, and procedures based on changing regulatory requirements.
• Manage internal and third‑party investigation and deviation meetings.
• Communicate product quality issues to management and provide information affecting batch disposition or marketed batch status.

Qualifications

• Bachelor’s degree.
• Minimum eight years of experience in the pharmaceutical, medical device, vaccines, blood, or biologics industry.
• Minimum five years of experience in quality assurance with quality systems responsibilities.
• Supervisory experience preferred.

Competencies

• Knowledge of regulated quality systems management, including auditing, document control, training, system administration, customer feedback, deviation and complaint investigation, CAPA, change control, and handling regulatory inspections.
• Experience with GxP regulations and interaction with regulatory/accreditation agencies.
• Understanding of process design/redesign, performance measurement systems, and audit procedures.
• Strong organizational and computer skills.
• Ability to manage multiple projects, technical personnel, and information independently.

Physical Demands

• Occasionally required to walk.
• Constantly required to sit.
• Occasionally required to lift light weights (less than 25 pounds).
• Specific vision abilities: close vision, color vision, and ability to adjust or focus.
• Some travel required, including overnight stays.

Work Environment

The noise level in the work environment is usually quiet.

Schedule

On‑site, Monday through Friday.