Senior Quality Systems & Regulatory Compliance Lead

Phoenix VX; Georgia; On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Medical insurance

Dental and vision benefits

401(k) with company match

Relocation assistance

Job summary

Phoenix VX, Albany, GA, seeks a Quality Systems & Compliance Manager to lead QMS and regulatory compliance at its manufacturing site. You will oversee Change Control, Document Control, CAPA, investigations, audits, supplier quality, and quality records to ensure an inspection-ready operation.

Ideal candidates bring GMP manufacturing expertise in medical devices/pharma and strong ISO 13485, 21 CFR 820, EU MDR knowledge, plus leadership experience across operations and quality teams.

Qualifications

• 8+ years of quality experience within a GMP-regulated manufacturing environment.
• Experience within pharmaceutical, medical device, life sciences, or another highly regulated GMP manufacturing environment.
• Hands-on experience with Quality Systems, particularly Change Control, Document Control, investigations, CAPA, audits, and Quality records.
• Experience administering or working with electronic QMS/document management platforms such as TrackWise Digital, Documentum, D2, SAP, or comparable systems.
• Working knowledge of GMP requirements and Quality Management System principles.
• Medical device manufacturing experience is strongly preferred but not required for an otherwise highly qualified Quality Systems professional.
• Knowledge of ISO 13485, 21 CFR medical device regulations, EU MDR 2017/745, and ISO 14971 is highly desirable.
• Experience supporting internal audits, external audits, supplier audits, and regulatory inspections.
• Bachelor's degree in Life Sciences, Engineering, Chemistry, Biology, Quality, or a related discipline; substantial relevant industry experience may be considered in lieu of a degree.
• Strong written and verbal communication skills across Operations, Quality, Regulatory, Supply Chain, and senior leadership.
• Ability to manage multiple Quality initiatives, establish priorities, resolve compliance issues, and meet deadlines.
• Experience serving as or supporting PRRC knowledge or experience is a plus.

Responsibilities

• Lead and maintain the site's Quality Management System (QMS) and 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 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 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 with Operations, Manufacturing, QC, Supply Chain, Engineering, Regulatory, and other 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.

Skills

Change Control

Document Control

CAPA

Audits

Quality Records

QMS administration

TrackWise Digital

Documentum

D2

SAP

Quality principles

Education

Bachelor’s degree in Life Sciences/Engineering/Chemistry/Biology/Quality

Tools

TrackWise Digital

Documentum

D2

SAP

Job description

Phoenix VX, Albany, GA, seeks a Quality Systems & Compliance Manager to lead QMS and regulatory compliance at its manufacturing site. You will oversee Change Control, Document Control, CAPA, investigations, audits, supplier quality, and quality records to ensure an inspection-ready operation.

Ideal candidates bring GMP manufacturing expertise in medical devices/pharma and strong ISO 13485, 21 CFR 820, EU MDR knowledge, plus leadership experience across operations and quality teams.