Quality Systems and Compliance Manager | Pharma

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

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.

KEY RESPONSIBILITIES

• 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.

MINIMUM QUALIFICATIONS

• -8+ years of Quality experience** within a regulated manufacturing environment strongly preferred.
• - Experience within **pharmaceutical, medical device, life sciences, or another highly regulated GMP manufacturing environment**.
• - Demonstrated hands‑on experience with **Quality Systems**, particularly Change Control, Document Control, investigations, CAPA, audits, and Quality records.
• - Experience administering or working extensively within 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/or regulatory inspections**.
• - Previous leadership or supervisory experience, including responsibility for developing Quality or laboratory personnel.
• - Bachelor's degree in **Life Sciences, Engineering, Chemistry, Biology, Quality, or a related technical discipline** preferred; substantial relevant industry experience may be considered in lieu of a degree.
• - Strong written and verbal communication skills with the ability to work effectively across Operations, Quality, Regulatory, Supply Chain, and senior leadership.
• - Demonstrated ability to manage multiple Quality initiatives, establish priorities, resolve compliance issues, and meet critical deadlines.
• - Experience serving as or supporting a **Person Responsible for Regulatory Compliance (PRRC)** is a plus.

WHAT WILL DIFFERENTIATE YOU

Candidates will stand out if they combine strong Quality Systems expertise with practical manufacturing experience. Particularly valuable backgrounds include:

• * Medical device Quality Systems or compliance
• * Pharmaceutical or GMP manufacturing Quality
• * Change Control system ownership or administration
• * Document Control/QMS administration
• * CAPA and investigation leadership
• * TrackWise Digital, Documentum, or D2
• * ISO 13485 and EU MDR compliance
• * Internal and external audit leadership
• * Validation Quality oversight
• * Experience spanning Operations, Production, QC, and QA
• * PRRC knowledge or experience

LEADERSHIP SCOPE

This position reports to the U.S. Quality Lead and provides leadership within the site's Quality organization, including oversight of approximately 7–8 QC Laboratory team members.

The successful candidate should be comfortable operating both strategically and hands‑on leading Quality Systems and compliance initiatives while remaining close enough to site operations to identify issues, coach employees, and drive solutions.

COMPENSATION & BENEFITS

The organization offers a highly competitive total rewards package, including:

• * Base salary of $90,000–$115,000 per year
• * 10% annual bonus opportunity**
• * Medical insurance with 100% of employee and dependent premiums paid by the company
• * Dental and vision benefits
• * 100% company match on the employee's first 4% 401(k) contribution, subject to plan eligibility requirements
• * Paid holidays and PTO
• * Company shutdown period
• * Financial wellness resources
• * Relocation assistance available on a case‑by‑case basis

WHY CONSIDER THIS OPPORTUNITY

This is an opportunity to take ownership of critical Quality Systems within an established manufacturing operation backed by a privately held international healthcare organization. The role offers significant visibility and the ability to directly influence Quality culture, regulatory compliance, audit readiness, Quality System effectiveness, and continuous improvement across the site.

For an experienced Quality professional who enjoys being close to manufacturing operations, not simply managing Quality from behind a desk, this position offers the opportunity to make a measurable impact while leading and developing an established team.

Dougherty County, Georgia also offers a lower-cost lifestyle, access to parks and outdoor recreation, and a family‑oriented community for candidates considering relocation.

EQUAL OPPORTUNITY

Qualified applicants will be considered for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other characteristic protected by applicable law.