| Title: | Head, Quality Assurance |
|---|---|
| ID: | 1012 |
| Location: | Philadelphia, PA |
| Department: | N/A |
About SwanBio Therapeutics
SwanBio is a privately held, newly established biotechnology company focused on the discovery and development of innovative gene therapy products for the treatment of central nervous system (CNS) disorders and diseases. SwanBio has a deeply experienced leadership team and is building an open, innovative culture that trusts its people, processes and science to deliver scientific, clinical and business success. SwanBio’s lead investor is Syncona, a premiere investment partner focused on building companies delivering transformational healthcare treatments. Sycona has a deep pool of capital and they are established leaders in the development of genetic medicine. In particular, they present a legacy of success in long term investment strategies for companies in the Gene and Cell Therapy space. Our goal is to become a world-leader in treating neurodegenerative diseases. With locations in Philadelphia and Boston, the SwanBio Team is building a strong pipeline of gene therapy development programs with a directed focus on critical unmet medical needs for CNS diseases.
The Opportunity
SwanBio is seeking an experienced Quality leader to join the Quality Operations team. The Head, Quality Operations will report directly to the CTO and lead the development and implementation of SwanBio’s quality management system. The Head will play a lead role in the Technical Operations group and will provide QA oversight of Contract Manufacturing and Contract Testing Organization activities for Swan’s clinical stage products and investigative drugs for use in clinical trials. The Head will be responsible for internal QA activities as well. The Head, Quality Operations will work closely with internal manufacturing and quality control functions, as well as the entire Technical Operations group at SwanBio.
- Establish, maintain, and have oversight for a clinical phase-appropriate, Quality Management System (QMS)
- Review Quality Agreements (for GMP manufacturers, QC testing facilities, and GMP storage facilities)
- Be responsible for vendor selection / qualification (for GMP manufacturers, QC testing facilities, and GMP storage facilities) and including facility audits
- Perform operational Quality Assurance functions associated with administration of the QMS, including but not limited to lot release / disposition activities, training of internal personnel, developing and implementing product specification and stability protocols / establish product expiry
- Provide QA support and oversight for all of Swan’s GMP-based activities at CDMOs and external laboratories including review and approval of manufacturing and testing batch records, and review of quality documentation including OOS results, CAPAs
- Ensure compliance with cGMPs regulations and industry guidelines
- Keep abreast of industry developments, forthcoming regulations, guidance, best practices etc.
- Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
- Continue the development, implementation, and revision of corporate quality systems as the organization continues to evolve.
- BA/ BS and a minimum of 8 years in Quality Assurance, including experience with external manufacturing quality oversight
- Experience and/or knowledge of gene therapy manufacturing and testing beneficial, but not required. However, must have experience with biologics-based therapeutics at a minimum.
- Experience interacting with contract manufacturing and contract testing organizations, including identifying, communicating and resolving complex issues
- Experience with disposition, deviation investigations, change control, and process improvements
- Strong knowledge of GxP regulations, quality systems, and guidance documents
- Excellent organizational and project management skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Ability to communicate above and below level in a way that fosters relationship building, including external relationships with vendors
- Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
- Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines
- Pro-active in identifying opportunities with a strong solution minded approach and flexibility to emerging challenges
About the Benefits
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs including bonus and stock option plans. Additionally, SwanBio Therapeutics offers all team members a comprehensive benefits program including: medical, dental, vision care, 401(k), paid vacation and Holiday time.
