Quality Management Specialist II (2649-1)

Overview
We are seeking a detail-oriented and proactive Quality Management Specialist to support Good Clinical Practice (GCP) quality oversight across multiple clinical studies. This role will partner closely with cross-functional teams, Quality leadership, and external vendors to ensure compliance, support audits, contribute to inspection readiness, and assist in the development and review of controlled documents. The ideal candidate will have a strong interest in clinical quality, solid foundational GCP knowledge, and the ability to collaborate effectively across teams.

Key Responsibilities
Study Quality Oversight

• Shadow 3 ongoing studies and support 7 additional studies from planning through reporting to provide Quality oversight and recommend best practices.
• Communicate and collaborate with cross-functional stakeholders, including Clinical Management and Functional Areas, regularly attending study and project-level meetings.

Quality Issue Management

• With guidance from Senior GCP Level 1 team members, support evaluation of critical quality issues, potential Serious Breaches, significant noncompliance, data integrity concerns, and protocol deviations.
• Escalate issues to Senior Management and conduct periodic follow-up on resolution activities for assigned studies.

Audit & Risk Assessment Support

• Contribute to annual GQM audit planning by supporting risk assessments and recommending the number of site and vendor audits based on study risk.
• Provide study-level information and documentation to GCP Level 2 and audit teams in preparation for audits.
• Participate in vendor risk assessments to inform the annual Vendor Audit Plan.

CAPA, Documentation, & Quality Governance

• Assist in reviewing Corrective and Preventive Actions (CAPAs) related to audits, inspections, quality issues, and eTMF findings.
• Participate in weekly, monthly, and quarterly GQM/GCP governance meetings.
• Attend QA-to-QA and Quality Council meetings with CRO partners alongside a Senior GCP team member.
• Contribute to the review and harmonization of controlled documents (protocols, ICFs, CSRs, amendments, SOPs, templates, etc.).

Training & Inspection Readiness

• Receive formal GCP training on ICH E6(R3), 21 CFR–related modules, and additional quality materials.
• Participate in weekly team training and support meetings.
• Support inspection readiness activities across Sponsor, Site, and CRO functions, including delivering “Do & Don’t” training, participating in interview prep/debriefs, and reviewing outputs from Inspection Readiness and Pre-Inspection visits.

Pharmacovigilance Support

• Review and assess the Pharmacovigilance System Master File (PSMF).
• Assist with PV-related quality activities as assigned.

Qualifications

• Bachelor’s degree required.
• Pharmaceutical, biotech, or clinical research background preferred.
• Foundational knowledge of GCP and ICH E6 guidelines strongly preferred.
• Strong communication, organization, and collaboration skills with the ability to support multiple projects simultaneously.
• Detail-oriented with an interest in quality assurance and compliance.

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.