GMP Compliance and Quality Assurance Auditor and SOP Technical Writer.

ProPharma•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 according to their practical experience and training. Project areas may include QMS development, QA oversight, auditing, cell and gene therapies, and regulatory agency action responses. The role 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 position is expected to maintain a percentage of billable project work determined quarterly. Depending on geographic location and qualifications, the consultant may undertake client MIA/WDA projects, support ProPharma’s MIA license, perform QP batch certification, and function as a QP, RP, or RPi for clients. Eligible QPs may be assigned as QP for the ProPharma MIA License, with responsibilities defined in its supporting QMS.

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.
Expertise in GxP systems and the ability to provide consultation based on prior experience and system knowledge.
Strong working knowledge of GxP principles, including the Code of Federal Regulations and EU GMP/GDP regulations.
Ability to plan, organize, control, and execute projects in a way that earns and maintains client confidence.
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 consulting services.
Quality orientation, high attention to detail, and strong analytical skills.
For auditing-focused roles, at least 1 year of experience leading audits, including preparation, conducting audits, and writing final reports, and recent experience performing at least 5 audits in the past year, reflected in the candidate’s audit log.
As applicable, previous registration as a Qualified Person.

Nice To Haves

Graduate degree (MSc or PhD) in a scientific discipline.
For EU employees, ability to convey information and instructions accurately in another European language in addition to English.
As applicable, eligibility to be registered as a Qualified Person (QP), Responsible Person (RP), and Responsible Person import (RPi).

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 geographic location, manage and undertake client MIA/WDA projects and work related to the ProPharma MIA license, including QP batch certification, GxP auditing, and QMS development.
Keep current 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 efforts by developing social media content and blogs promoting CQA services.
Promote continual improvement in customer satisfaction, with an emphasis on CQA consulting services.
Provide CQA-specific training to clients and associates in other business units, as applicable.
Support clients and ProPharma functional units with GxP issues, including deviations and non-conformances, and consult on appropriate CAPA implementation.
Help ensure company operations comply with quality principles and participate in developing quality systems through SOP writing and training.
Engage employees at all levels to educate them on compliance and quality assurance and drive continuous improvement.
Maintain a percentage of billable project work as determined quarterly.
Perform other duties as assigned.