Sr. Director, GMP Quality
Asklepios BioPharmaceutical, Inc. (AskBio) is a privately held AAV gene therapy-based company founded in 2001 in response to parents and patient advocates seeking treatment for rare, genetically derived and life-threatening childhood illnesses. Our scientific platform is based on the work of Dr. Jude Samulski and Dr. Xiao Xiao. Our history has been largely mission driven to help patients without other options; AskBio carries on this patient-focused mission today. We are headquartered in Research Triangle Park, North Carolina.
We are looking for a Senior Director, GMP Quality to join the AskBio team.
About the role
The Senior Director, GMP Quality is responsible for establishing and maintaining AskBio’s GMP Quality Management System. This role will assure corporate compliance with applicable GMP international, national, provincial and state regulations through the development and oversight of a robust quality management program.
- Partner with AskBio’s executive management team to establish and maintain a Culture of Quality
- Establish foundation elements of GMP QMS, including policies, manuals, SOPs and specifications
- Directly oversee internal GMP manufacturing activities
- Recruit and manage QA and QC teams to support GMP manufacturing and laboratory requirements at our RTP location
- Partner with and oversee third-party contract manufacturers and contract laboratories. Ensure that the quality systems of external partners comply with regulatory and commercial expectations. Establish and maintain Quality Agreement(s) with vendors
- Maintain quality systems in support of a cGMP operation
- Review all batch-related documentation and ensure resolution of issues to release product that will support preclinical toxicology studies and Phase l/ll/III clinical studies, including batch records, QC data, primary and secondary packaging, label control, corrective and preventative actions, quality events management (e.g., non-conformances, deviations, etc.), training, etc.
- Ensure that products are manufactured in compliance with regulatory and GMP guidelines
- Compile and verify all batch-related documents into a final product lot disposition package
- Review and approve Investigations / OOS / Change Controls
- Communicate lot disposition pending issues to management
- Perform periodic review of all GMP procedures
- Gather information for quality performance metrics and deploy these data for management review and continuous improvement of areas of responsibility [including review of, GMP document management, and GMP regulatory compliance]
- Work with the manufacturing group as a production-area Quality Assurance representative
- Perform internal and external audits and support regulatory inspections of AskBio and our third-party contract partners
- Work closely with GLP/GCP quality counterparts to ensure a comprehensive compliance program for all aspects of pharmaceutical quality
- Perform other duties as required
- 10+ years of Quality and/or Manufacturing experience (at least 8 years must be in Quality) in pharmaceutical, biotech, or biologics GMP regulated manufacturing environment
- 5+ years in a management role
- Bachelor’s degree in an allied health and/or scientific-related field
- Deep knowledge of GMP guidelines and Quality expectations for preclinical toxicology and clinical phase programs
- General knowledge of aseptic manufacturing processes
- Working knowledge of quality systems and ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards
- Ability to multitask among multiple projects and teams and work independently in a fast-paced, highly interactive environment
- Great interpersonal skills
- Excellent communication skills (written and verbal)
- Ability to communicate and work independently with scientific and/or technical personnel
- Strong attention to detail
- Highly organized desired skills
- Good documentation practices
- Proficiency in MS Word, Excel, PowerPoint, and other applications
We offer a competitive total rewards package. Are you our next great discovery?