Piper Companies is searching for an experienced GCP QA Professional to join a global biopharmaceutical company producing therapies for neurology and rare disease disorders as Senior Quality Assurance (GCP) Specialist . The Sr. QA Specialist will be responsible for the auditing and oversight of all QA compliance GxP activities within their assigned area. The Sr. QA Specialist opportunity is preferred as HYBRID in Atlanta, GA when not traveling for audits.

Responsibilities for the Sr. QA Specialist include:
• Overseeing and managing QA compliance for GxP activities, primarily GCP
• Communicating and collaborating with regulatory authorities & clients during regulatory inspections and sponsor audits
• Creating and implementing process improvements and nourishing key relationships with stakeholders
• Leading meetings, trainings, presentations, and timeline communications

Qualifications for the Sr. QA Specialist include:
• 10+ years of experience in the pharmaceutical industry and 3 - 5 years of clincial quality experience
• In-depth GCP experience in auditing internally and externally across all clinical research phases
• Ability to travel to research sites when necessary

Compensation for the Sr. QA Specialist includes:
• Salary Range: $80/hr - $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

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