GxP Compliance & QA Auditor + SOP Writer (Remote)

ProPharma; Raleigh (NC); Hybrid; USD 110,000 - 150,000; Full time

Job summary

ProPharma is seeking a Compliance and Quality Assurance Consultant (CQA) to support management of GxP compliance projects and provide consulting services across GMP, GCP, GLP.

The role covers QMS development, QA oversight, auditing, and regulatory action responses, with opportunities for training and client-facing work. The position may involve travel and hybrid work arrangements, including some office time.

Qualifications

• Knowledge of US FDA, ICH, EMA, MHRA regulations and guidance documents.
• Expertise in GxP systems and capable of providing consultation based on experience and system knowledge.
• Ability to earn and maintain a client’s confidence through planning, organizing, controlling, and executing a project.
• Willingness and ability to travel as required.
• Excellent written and oral communication skills in English; additional European language helpful for EU employees.
• Ability to manage multiple tasks within QA and relevant consulting services (QMS development, QA oversight, auditing, regulatory actions).
• Quality orientation and high attention to detail.
• Strong analytical skills.

Responsibilities

• Represent the company in assigned areas of quality assurance and regulatory / GxP.
• Provide consultation and support the management of projects within the CQA business practice.
• Manage and undertake project work on client MIA / WDA projects, and PPG MIA license tasks (e.g., QP batch certification, GxP auditing, QMS development).
• Keep pace with regulatory and technological changes in the CQA field and develop subject matter expertise.
• Be a key team member in risk-based and phase-appropriate GxP projects.
• Participate in the sales process to identify scope and effort to address client needs.
• Support marketing efforts by promoting CQA services through content creation.
• Promote continual improvement regarding customer satisfaction with CQA services.
• Provide CQA training to clients and associates where applicable.
• Offer support to clients and ProPharma units for GxP deviations/non-conformances and CAPA implementation.
• Engage with employees to educate on compliance and quality assurance to drive improvement.
• Maintain a portion of billable project work as determined quarterly.
• EU/UK roles: possible QP/RP/RPi responsibilities as applicable.
• Other duties as assigned.

Skills

GxP compliance

Regulatory knowledge

Quality systems

Project management

Client communication

Auditing

Education

Bachelor's degree in life sciences

MSc/PhD preferred

QP/RP eligibility

Job description

ProPharma is seeking a Compliance and Quality Assurance Consultant (CQA) to support management of GxP compliance projects and provide consulting services across GMP, GCP, GLP.

The role covers QMS development, QA oversight, auditing, and regulatory action responses, with opportunities for training and client-facing work. The position may involve travel and hybrid work arrangements, including some office time.