Design Space InPharmatics (DSI), the North American division of Product Life Group (PLG), a leading global pharmaceutical consulting organization, is seeking a QA GCP Compliance Consultant to join our team in a fully remote capacity.
The successful candidate will serve as a subject matter expert and trusted advisor on Good Clinical Practice (GCP) compliance throughout the clinical trial lifecycle. This role requires hands-on experience in developing and implementing quality systems and Standard Operating Procedures (SOPs) related to investigator site management, Trial Master File (TMF) governance, data integrity, Corrective and Preventive Action (CAPA) processes, and sponsor/CRO oversight. The consultant will ensure that all quality and compliance documentation is inspection-ready, risk-based, and operationally practical while supporting adherence to global regulatory requirements and industry’s best practices.
Role and Responsibilities
- Demonstrated ability to author, review, and implement GCP-aligned Standard Operating Procedures across clinical trial operations,
- Drafting SOPs from inception, mapping them to applicable regulatory frameworks (including ICH E6 R3), establishing version control workflows, performing gap analyses against existing procedural documents, and training staff on new or revised procedures.
- Expertise in conducting structured evaluations of Quality Management Systems (QMS)clinical SOP library against the requirements of ICH GCP E6 R3,
- Perform systematic gap analyses to identify areas where existing SOPs are absent, inadequate, or misaligned with E6 R3’s updated expectations around risk-based monitoring, quality tolerance limits (QTLs), essential document management, and oversight of outsourced activities,
- Proven capacity to serve as a subject matter expert and trusted advisor on GCP compliance matters throughout the clinical trial lifecycle, This encompasses providing real-time QA guidance to sponsors, CROs, and investigator sites on protocol adherence, regulatory submissions, monitoring activities, and risk-based quality management.
- Interpret complex regulatory requirements, advising on corrective and preventive actions (CAPAs), and translating GCP obligations into actionable operational recommendations.
- deliver a structured compliance assessment report with prioritized remediation recommendations, propose new or revised SOPs to close identified gaps, and support implementation of a fit-for-purpose QMS that withstands Health Authority scrutiny,
- Analyze and monitor the key performance indicators of quality audits and liaise with the Quality Management System (QMS) team,
- Advise and support the audited structures in the development and implementation of corrective and preventive actions (CAPAs) to ensure regulatory compliance and accordingly do the validation and follow up,
- Audit Referent take part in the development of the audit program, interacts with the QMS Project Team Member,
- Be part of the outsourcing team for the outsourcing of GCP Audits by drafting the specifications, review of Requests for proposal, subcontractor selection, planning the activities of the subcontractor,
- Support GCP Health Authority inspections, including preparation, facilitation, and follow-up activities,
- Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to trial conduct and data integrity.
Qualifications and Education Requirements
- Advance scientific degree in a closely related field; Pharmacist (Pharm D) or Master of science and specific Quality Assurance training is preferred,
- Minimum of 7-10 years’ experience in quality assurance or related role including experience on GCP audit conduct,
- Knowledge of applicable regulations to GCP and GVP preferred,
- Maintain up-to-date knowledge of global GCP regulations (ICH E6) and industry trends, identifying new requirements to ensure an elevated level of quality is maintained across all clinical development programs,
- Previous experience within pharmaceutical companies,
- Language: English, Other speaking languages are a plus.
Additional Notes
- This is a fully remote, independent consultant role. Consultants are engaged on a project basis and may be assigned to one or multiple concurrent engagements. Hours are not fixed and will fluctuate based on project requirements, milestones, and client needs. Consultants retain full autonomy to accept or decline project engagements at their discretion,
- The responsibilities outlined in this position represent a general summary of the consulting role and are not intended to be all-inclusive. PLG reserves the right to amend this description as client program needs evolve,
- All applications are reviewed by our human hiring team. No automated screening or AI-based filtering is used to evaluate or eliminate candidates. Every candidate receives personal consideration.