Quality Systems and Compliance Manager | Pharma

A well-established international healthcare and medical products organization is seeking a Quality Systems & Compliance Manager to lead Quality Management System (QMS) and regulatory compliance activities at its Albany, Georgia manufacturing facility.

This is a highly visible site quality leadership role responsible for maintaining an effective, inspection-ready QMS supporting the manufacture and release of an established medical device product. The position will oversee critical quality systems including Change Control, Document Control, CAPA, investigations, audits, supplier quality, quality records, training, and regulatory compliance.

The ideal candidate brings strong Quality Systems experience from a GMP-regulated pharmaceutical or medical device manufacturing environment. Direct medical device experience is highly desirable, particularly experience with ISO 13485, 21 CFR Part 820/QMSR, EU MDR, and ISO 14971.

Candidates who developed their careers through multiple areas of manufacturing such as Operations, Production, QC, and Quality Assurance are especially encouraged to apply.

• Lead and maintain the site's Quality Management System (QMS) and associated compliance programs supporting medical device manufacturing and product release.
• Serve as a key site owner and administrator for Change Control, including Quality approval and assessment of proposed changes.
• Oversee Document Control, controlled documentation, quality records, investigations, deviations, CAPAs, and associated QMS workflows.
• Review and approve investigations and corrective/preventive actions, ensuring appropriate root-cause analysis, effectiveness checks, documentation quality, and timely closure.
• Maintain a high level of inspection and audit readiness across the manufacturing site.
• Lead and support internal audits, supplier audits, regulatory inspections, and external audit activities, including responses and corrective actions.
• Monitor Quality System performance and develop quality metrics, trend reports, compliance indicators, and management review information.
• Ensure applicable Quality processes align with ISO 13485, 21 CFR medical device requirements, EU MDR 2017/745, ISO 14971, and other applicable regulatory standards.
• Incorporate appropriate risk-management principles throughout the product and Quality System lifecycle.
• Assess Change Controls for potential impact to regulatory filings, product documentation, validation requirements, labeling, and global regulatory commitments.
• Provide Quality oversight for validation activities, including review of validation strategies, protocols, execution documentation, and associated Quality records.
• Manage and support the Supplier Quality program, partnering with Supply Chain, Procurement, Operations, and external suppliers to ensure materials and components meet established requirements.
• Support medical device documentation throughout the product lifecycle, including applicable standards, verification activities, product specifications, and Quality documentation.
• Provide Quality oversight for artwork and labeling approvals and help ensure labeling meets applicable regulatory requirements.
• Establish and support site Quality training requirements and provide guidance to employees regarding QMS and regulatory expectations.
• Partner closely with Operations, Manufacturing, QC, Supply Chain, Engineering, Regulatory, and other cross-functional stakeholders to identify compliance gaps and implement sustainable solutions.
• Lead, coach, and develop Quality personnel while promoting accountability, knowledge transfer, continuous improvement, and a strong Quality culture.

• -8+ years of Quality experience
  ** within a regulated manufacturing environment…