Sr. Quality Assurance Specialist

Senior Specialist, Quality Assurance Provides Quality Assurance oversight of AskBio’s Vendor Qualification Program for GCLP, GLP, GCP (and GMP vendors, as needed). This key individual performs vendor assessments and occasional audits (virtual and on‑site) alongside subject matter experts, ensuring vendor qualification activities support compliance with applicable GLCP, GLP, GCP, and GMP guidelines and relevant national/international/local regulations. This position will work closely with the GCP/GLP/GCLP QA and SMEs. This position will be office‑based in RTP, NC and will report to the Senior Director, QA – Product Quality. Job Responsibilities Maintain and manage a risk‑based model for qualification and quality oversight of GCLP, GCP, GLP vendors (and GMP vendors, as needed) in compliance with AskBio SOPs Assure the conduct of regular vendor assessments or audits of GCLP, GCP, GLP (and GMP vendors, as needed) to evaluate regulatory compliance, performance, and improvement opportunities (via questionnaire and/or audit), involving GCP/GLP/GCLP QA and SMEs, as appropriate Serve as primary interface with GCP/GLP/GCLP QA and related functional area staff on topics relevant to vendor qualification Identify, track status, and schedule audits and assessments of GCLP, GCP, GLP (and GMP vendors, as needed) Advance the Vendor Qualification program by identifying opportunities and implementing risk‑appropriate enhancements to program infrastructure Support functional area staff to resolve vendor observations and quality issues, including risk/impact assessment and CAPA development, execution, and effectiveness checks Maintain and evolve mechanisms that ensure awareness and application of Vendor Qualification QMS requirements Contribute to the development, implementation, and maintenance of SOPs, Policies, and Quality Agreements Support coordination and management of regulatory agency inspections and parent company audits, as appropriate Perform other duties as assigned by Quality Assurance Management Travel may be required to perform audits (approximately 20%) Minimum Requirements Bachelor’s degree in science, health care, business, or other relevant field and 5+ years of relevant industry experience Knowledge of industry best practices and regulatory requirements, including Good Clinical Laboratory Practices (GCLP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) Experience in vendor qualification or vendor management Strong collaborative skills; ability to work cross‑functionally in a matrixed environment Ability to proactively and diplomatically identify and resolve quality issues/discrepancies Ability to prioritize, organize, work independently, and manage multiple projects/tasks simultaneously Analytical mindset with strong attention to detail Excellent interpersonal, verbal, and written communication skills Proficiency in MS Word, Excel, PowerPoint, and other applications Preferred Education, Experience and Skills Laboratory, clinical research, and/or Quality Assurance (or related) experience Audit experience, including ASQ certification for auditing (CQA) or similar Knowledge of Good Manufacturing Practices (GMP) AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job-related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at View phone number on click.appcast.io or sending us an email at View email address on click.appcast.io. #J-18808-Ljbffr