GMP Compliance and Quality Assurance Auditor and SOP Technical Writer.

ProPharma Group•Raleigh, NC

19d

About The Position

The Compliance and Quality Assurance Consultant (CQA) supports the management of compliance and quality assurance projects and provides consulting and contract services to clients addressing quality and regulatory/GxP issues. The consultant is assigned to quality assurance and regulatory/GxP compliance projects based on the practical experience and training reflected in their CV. Projects may include QMS development, QA oversight, auditing, cell and gene therapies, and regulatory agency action response. The consultant also supports the design, implementation, monitoring, maintenance, and promotion of ProPharma’s CQA program, policies, and strategies in compliance with GxP regulations and industry trends. The role may include client MIA/WDA projects, work supporting ProPharma’s MIA license, QP batch certification, GxP auditing, and QMS development, depending on project assignment and location. The position is expected to maintain a percentage of billable project work determined quarterly. EU or UK consultants may function as QP, RP, or RPi for clients when applicable; an eligible QP may be assigned as QP for ProPharma’s MIA License. The consultant contributes to risk-based and phase-appropriate GxP projects, supports sales and marketing activities, provides CQA-specific training when applicable, and assists clients and ProPharma functional units with GxP issues such as deviations and non-conformances. The role includes advising on CAPA, ensuring company operations comply with quality principles, developing quality systems through SOP writing and training, and educating employees at all levels to drive continuous improvement. Other duties may be assigned. ProPharma supports remote working and encourages employees who live within a reasonably short commute of an office to work hybrid, with in-person work agreed with their manager. Applications are reviewed by a member of the recruitment team; the company states it does not use AI screening tools. ProPharma is an Equal Opportunity Employer committed to diversity, equity, and inclusion.

Requirements

Bachelor’s degree or similar college degree in a scientific discipline, at minimum.
At least 5 years of relevant experience in quality assurance and regulatory/GxP compliance.
Knowledge of applicable US FDA, ICH, EMA, and MHRA regulations and guidance documents.
Strong working knowledge of GxP principles, including the Code of Federal Regulations and EU GMP/GDP regulations.
Expertise in GxP systems and ability to provide consultation based on prior experience and system knowledge.
Ability to earn and maintain client confidence through appropriate project planning, organization, control, and execution.
Willingness and ability to travel as required.
Strong interpersonal and communication skills, with the ability to interact professionally and positively with clients and coworkers.
Effective written and oral communication skills, including the ability to convey information and instructions accurately in English.
Ability to manage and execute multiple tasks across compliance, quality assurance, and related Quality and Compliance Consulting services.
Quality orientation, high attention to detail, and strong analytical skills.
For roles primarily focused on auditing, at least 1 year of experience leading audits, including preparation, conducting audits, and writing final reports.
For roles primarily focused on auditing, recent auditing experience is required: at least 5 audits performed in the past year, documented in the candidate’s audit log.

Nice To Haves

Graduate degree (MSc or PhD) in a scientific discipline.
Ability to convey information and instructions accurately in another European language, preferred for EU employees.
Eligibility for registration as a Qualified Person (QP), Responsible Person (RP), and Responsible Person import (RPi), as applicable.
Previous registration as a Qualified Person, as applicable.

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.
As applicable to project assignment and location, manage and undertake client MIA/WDA projects and work supporting ProPharma’s MIA license, including QP batch certification, GxP auditing, and QMS development.
Keep pace with regulatory and technological changes in the CQA field and develop subject matter expertise.
Contribute to the implementation and successful execution of risk-based and phase-appropriate GxP projects.
Participate in the sales process as required and identify the scope and effort needed to address client needs.
Support marketing by developing social media content and blogs promoting CQA services.
Promote continual improvement in customer satisfaction, particularly regarding CQA consulting services.
Provide CQA-specific training to clients and associates in other business units, as applicable.
Support clients and ProPharma functional units when GxP issues, including deviations and non-conformances, arise.
Advise on the implementation of appropriate CAPA to resolve deviations and non-conformances.
Help ensure company operations comply with quality principles and participate in developing quality systems through SOP writing and training.
Educate employees at all levels on compliance and quality assurance to drive continuous improvement.
Maintain a percentage of billable project work as determined quarterly.
When applicable, function as a QP, RP, or RPi for clients; an eligible QP may be assigned as QP for ProPharma’s MIA License.
Perform other duties as assigned.