Manager, Clinical Quality Assurance
1001 Winstead Dr, Ste 310 Cary, NC 27513 US
This position contributes to the Company’s success by managing the development, maintenance, and oversight of the GCP activities related to clinical trials sponsored by the Company.
SUMMARY OF KEY RESPONSIBILITIES • Manages global studies for one or more product candidates from early development to regulatory approval (Phases 1-3) and beyond, to achieve a high-quality product for the marketplace and business success for the Company in cooperation with clinical development departments;
• Represents quality assurance on key sponsor and study project team including dissemination of key Quality information, guidance, training, and support;
• Participates in the evaluation and qualification of CROs and other clinical vendors/suppliers in coordination with Clinical Operations teams;
• Ensures clinical processes are conducted in accordance with the Company’s procedures and applicable regulatory GCP requirements, sponsor SOPs, study protocols, and current industry standards, regulations, and guidelines;
• Captures QA metrics and surveillance risk assessment for clinical programs. Drives inspection readiness by organizing and overseeing mock GCP inspections. Represents company in regulatory authorities GCP inspections;
• Confirms company Clinical SOPs are clear, consistent and aligned with other related SOPs;
• Conducts Investigator Site, Trial Master File (TMF), Vendor, System/Process Audits, investigator brochure and clinical Protocol/Study Plan reviews/audits in cooperation with Clinical Operations;
• Reviews clinical and regulatory documents, ensuring quality, accuracy, and completeness;
• Authors audit plans, executes audits and publishes audit reports ensuring that audit findings/observations are addressed and resolved in a timely manner;
• Collaborates with auditees and audit stakeholders to ensure appropriate root cause identification understanding and alignment. Tracks, reviews, approves, and assesses the adequacy of CAPAs through completion;
• Works closely with development team to ensure/coordinate appropriate and complete resolution of findings/non-compliant issues, quality investigations, temperature excursions, product complaints, deviations etc., in a timely manner;
• Identifies and remediates potential systemic gaps and coordinates with the appropriate stakeholders;
• Escalates issues of critical non-compliance and/or lack of urgency in remediation to Quality Assurance and Clinical Operations teams;
• Performs other duties as assigned by manager. ?
REQUIRED QUALIFICATIONS AND SKILLS • BS, preferably in a scientific/technical discipline.
• Experience working at a CRO
• Minimum of 5 years of Clinical Quality Assurance experience required, with 3 years of auditing experience/oversight experience in the regulatory compliance environment or an equivalent combination of education and experience.
• Excellent communication and negotiation skills; capable of making decisions, problem-solving, collaborates with other team members in a positive manner, and works in a leadership role.
• Excellent organizational skills and ability to work on multiple projects with competitive timelines are required.
• Strong attention to detail.
• Strong knowledge of FDA regulations, ICH guidelines, and Good Clinical Practices and their application to clinical trials.
• Demonstrated ability to work effectively in cross functional team environment.
• Strong proficiency with Microsoft Office Suite and clinical trial software/programs
• Ability to travel occasionally, 25% of the time or less.