Piper Companies is actively seeking a Senior Quality Assurance (GCP) Specialist to join a global biopharmaceutical organization producing therapies for neruology and rare disease disorders. The Sr. QA Specialist will be responsible for the auditing and oversight of all QA compliance GxP activities within an assigned area. The Sr. QA Specialist opportunity is HYRBRID and located in Atlanta, Georgia.

Responsibilities for the Sr. QA Specialist includes:

* Provide oversight and management of QA compliance GxP activities, primarily GCP

* Communicate and collaborate with regulatory authorities and sponsors during regulatory inspections and sponsor audits

* Create and manage process improvements, audit and project knowledge, key relationships with stakeholders and clients, and cross-functional collaborations

* Lead meetings, trainings, presentations, and project timeline communications

Qualifications for the Sr. QA Specialist includes:

* 10 years of experience in the pharmaceutical industry and 3 - 5 years of clincial quality experience

* Established experience in GxP (GCP, GLP, GMP) auditing both internally and externally, and across all clinical research phases

* Ability to travel to research sites when necessary

Compensation for the Sr. QA Specialist includes:

* Salary Range: $80 - 87/hr. based on professional experience

* Competitive comprehensive benefits package included

Keywords:

QA compliance manager, quality assurance, QA, management, GxP, GCP, GLP, GMP, auditing, clinical research, regulatory, inspections, sponsor audits, stakeholder management, process improvement, travel, investigator site audits, TMF audits, QMS, communication, remote, united states, US

#LI-KF1