What are the responsibilities and job description for the Director Quality Assurance position at Bend Bioscience?
Why Join Bend Bioscience?
Mission And Culture
At Bend Bioscience, we Advance Health Through Innovation by developing and manufacturing therapies that improve patients' quality of life. We believe every employee plays a vital role in our mission to advance human health through innovative client partnerships. Whether you’re involved in development, manufacturing, testing, or contributing your expertise in other areas, your work will have a meaningful, positive impact on countless lives.
Do You
Your New Role At Bend Bioscience
In this role, you will be instrumental in defining a quality culture and building systems, policies, and procedures to define a compliant organization with quality instilled throughout all operational aspects. You will need to be able to apply your regulatory and quality experience to GMP requirements for investigational new medicines for use in the US and Europe.
Essential Functions (other Duties May Be Assigned)
Mission And Culture
At Bend Bioscience, we Advance Health Through Innovation by developing and manufacturing therapies that improve patients' quality of life. We believe every employee plays a vital role in our mission to advance human health through innovative client partnerships. Whether you’re involved in development, manufacturing, testing, or contributing your expertise in other areas, your work will have a meaningful, positive impact on countless lives.
Do You
- Love finding new and better ways to do things?
- Want to help develop medicines that improve patients' lives?
- Have a passion for learning and growth?
- Nerd out on science and technology?
- Value collaboration and teamwork?
- Embrace audacity and entrepreneurial thinking?
- Prioritize safety and lead by example?
- Care deeply about doing the right thing?
Your New Role At Bend Bioscience
In this role, you will be instrumental in defining a quality culture and building systems, policies, and procedures to define a compliant organization with quality instilled throughout all operational aspects. You will need to be able to apply your regulatory and quality experience to GMP requirements for investigational new medicines for use in the US and Europe.
Essential Functions (other Duties May Be Assigned)
- Provide leadership and guidance on quality to operations and technical functions for a dynamic early phase clinical focused CDMO organization focused on investigational new medicines
- Develop, implement, and administer QMS software system
- Lead the review and approve investigations, incidents, CAPAs, and laboratory investigation reports
- Lead and manage the GMP training program
- Lead and manage supplier and material qualifications
- Provide leadership and point-of-contact in regulatory and client audits
- Ensure organizational compliance with regulatory guidelines, company policies, procedures, work instructions, and training requirements.
- Represent Bend Bioscience quality and regulatory policy to the clients
- Support quality and regulatory aspects of client programs
- Collaborate with clients and suppliers on quality, regulatory, and technical issues
- Drive site specific continuous improvement of the Bend Bioscience Quality System
- Ensure Bend Bioscience is following cGMP guidelines and ensures the staff Is following Bend Bioscience Quality policies and SOPs
- Have a thorough understanding of GMP Regulations (FDA, EU, JP) and specific regulatory guidance, applicable to early phase clinical requirements and the production of investigational new medicines
- Minimum: Bachelor’s Degree in Science
- Minimum: 10 years of experience in the pharmaceutical industry, including a minimum of 7 years of QA experience
- Experience in drug product manufacturing and CDMO space preferred
