ABOUT THE COMPANY
At Scout Bio (www.scoutbio.co) our mission is to create innovative medicines for companion animals that are more convenient, effective and safe than those currently available.
We're applying cutting-edge technologies from the world of human medicine to companion animal health (dogs and cats).
Our world-class team of human and animal health biotechnology veterans has an enviable track record of success, and now we're looking for a Director of Quality Assurance to join our growing, international team.
Join us and play a key role in bringing gene therapy and cutting-edge therapeutic proteins to veterinary medicine, to improve the quality of life for companion animals and their owners.
Our labs are based in the historic Curtis Building in beautiful Old City, Philadelphia. We also have teams in Europe and Australia.
ABOUT THE ROLE
Reporting to the Vice President, Clinical and Regulatory Development, this new role will be based remotely within the United States, Western Europe, or any other reasonable location.
You will build and lead a world-class Quality Assurance team to support the development of novel biopharmaceutical products. This position and the QA team will build a partnership with our clinical, regulatory, research and manufacturing teams, establishing and monitoring quality framework and practices to prevent and mitigate quality issues.
You will be responsible for all pre-approval QA tasks related to the approval and licensure of our biopharmaceutical products which include proteins, antibodies, and gene therapies. Specifically, a large part of the role will involve GCP and GLP processes and audits. It may also involve the audit of GMP CDMOs.
You will be responsible for ensuring that all material is produced and all clinical and laboratory studies are performed to our desired quality standards.
You will be a key member of the Development leadership team.
Key duties
- Establish and maintain our quality assurance programs, systems and processes to provide appropriate oversight of pre-clinical, clinical and commercial manufacturing activities.
- Develop and implement quality design and quality assurance strategies for new products.
- Be a single point of accountability for identifying and managing the timely resolution of quality issues through our established partners.
- Develop quality assurance plans and systems to ensure all pre-approval (pre-clinical, clinical and development manufacturing) programs remain compliant with all applicable regulations and guidelines.
- Work closely with the R&D team on clinical and CRO audit plans for pivotal study programs, both GCP and GLP.
- Create and champion quality process enhancement initiatives to maintain an environment of continuous improvement.
- Develop and oversee GxP quality systems to support our development activities. Establish and maintain a GxP-compliant documentation control system.
- Ensure an effective and compliant vendor qualification program is in place for partners and suppliers.
- Maintain a state of readiness for inspection by regulatory agencies.
- Oversee Quality activities performed by contract testing labs, contract research organizations and contract manufacturers.
ABOUT YOU
You will have:
Skills, knowledge and experience
- A DVM, M.Sc or PhD in chemistry, biochemistry, pharmaceutical science, or other animal health or biology-related field. Candidates without advanced degrees but with additional relevant work experience will also be considered.
- 10+ years of experience in the pharmaceutical/biotechnology industry in a Quality Assurance position. At least 2 years of QA in the Animal Health industry is highly preferred.
- Conduct of GCP, GLP studies: (1) Development of R&D SOPs. (2) Experience reviewing protocols, reports and complex datasets. (3) Understanding of the GLP and GCP environment. (4) Experience performing audits of partners involved in development studies.
- Participation in FDA CVM audits of clinical and laboratory facilities. cGMP quality manufacturing experience is nice but not required. Qualified Person status is desirable, but is not a necessity.
- A clear understanding of FDA, EMA and ICH guidelines.
- Exceptional collaborative, interpersonal skills and exceptional work ethic.
- Strong people leadership and management experience in hiring, training and developing outstanding talent.
- Strong collaboration skills with a proven ability to build and maintain strong and effective relationships with cross-functional, cross-cultural project teams, internal and external customers, and business partners.
- The ability to travel, including domestic and internationally approximately 25% of the time.
Job Type: Full-time
Pay: $180,000.00 - $200,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Application Question(s):
- Do you possess all required work authorizations to work either in the United States (if you will work from the United States) or otherwise from your home location?
- What relevant qualifications (DVM, M.Sc or PhD in chemistry, biochemistry, pharmaceutical science, or other animal health/biology-related field), do you possess?
- Describe your Animal Health industry experience.
- Briefly describe your experience in a comparable position elsewhere.
Work Location: Remote