Sr. Quality Assurance Specialist
About The Position
AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. Our vision: Pioneering science to create transformative molecular medicines. Our mission: Lead innovative science and drive clinical outcomes to transform people's lives. Our principles: Advance innovative science by pushing boundaries. Bring transformative therapeutics to patients in need. Provide an environment for employees to reach their fullest potential. Our values: Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need. Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view. Embrace Responsibility. We are humbled by the enormity of our mission. We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers. Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action. Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through. 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)
- 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
- Experience in vendor qualification or vendor management
- 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
