Sr. Quality Assurance Specialist
About The Position
Opportunity for Secondment to AskBio. This role is available for a time period to be determined by leadership at both Bayer and AskBio. While most assignments range from one to two years, the exact duration will be based on business needs and mutual agreement. This secondment offers a unique chance to broaden your experience, expand your knowledge, and contribute meaningfully to AskBio’s mission: to advance gene therapy and change the lives of patients around the world. The Senior Specialist, Quality Assurance provides Quality Assurance (QA) 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.
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
Nice To Haves
- 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)
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). vendors
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
