Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. We have developed our Targeted Alpha Therapies, or TAT, platform together with our proprietary Fast-Clear linker technology to enable us to connect alpha particle emitting isotopes to antibodies and other targeting molecules in order to selectively deliver the alpha particle payloads to tumors. Our TAT platform is underpinned by our research and insights into the underlying biology of alpha emitting radiopharmaceuticals as well as our differentiated capabilities in target identification, candidate generation, manufacturing and supply chain and development of imaging diagnostics. We believe that our TATs have the potential to build on the successes of currently available radiopharmaceuticals and be broadly applicable across multiple targets and tumor types.
The Senior Director, Quality Assurance is responsible for the strategy, implementation and leadership of the Quality Unit at Fusion and is accountable for the continuous improvement, execution and administration of a comprehensive GxP Quality System in support of all drug development and manufacturing activities, directing GxP quality related activities across the organization to support global regulatory submissions (IND, BLA/MAA, etc.) and ultimately commercial launch of products. The Senior Director of Quality is responsible for ensuring the GxP Quality System developed meets all compliance requirements pertaining to Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP) and current Good Manufacturing Practices (cGMP) in accordance with ICH and EMA regulations. The Sr. Director, Quality Assurance will report to the Chief Scientific Officer.
- Establish phase appropriate Quality Systems to support Fusion’s growth into a fully integrated commercial biotechnology organization.
- Develop and implement GxP processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
- Establish and maintain phase-appropriate compliance for all aspects of our business.
- Ensure that Fusion’s Quality System meets or exceeds standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.
- Maintain an effective Quality governance and continually improve governance to meet business and compliance needs – Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance.
- Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management.
- Ensure products manufactured at CDMOs meet company quality standards and government regulations.
- Implement GCP Quality Assurance programs for clinical trials execution and reporting.
- Manage supplier/vendor qualification audit and inspection management in compliance with applicable GxP standards, FDA/EMA/ICH requirements, and other regulatory standards.
- Quality management of CMOs, CROs, contract test laboratories and other vendor services to ensure compliance of manufacture and testing of Fusion’s products.
- Ensure robust planning and execution of documentation for all regulated work and Regulatory submission-supporting activities, both internal and external (CRO, CMO).
- Review and edit Quality Agreements, contracts, supply agreements, etc., provide quality input to project/program plans, master service agreements and statements of work.
- Establish and manage a comprehensive internal compliance training program.
- Work cross functionally, representing the Quality group on discovery and development teams, line functions and to senior management for awareness of and compliance with quality/regulatory requirements.
- Help build and eventually manage a Quality Control department with internal cGMP
- Develop solutions to complex quality issues and work closely with senior management to prevent and resolve significant compliance issues.
Required Skills & Qualifications:
- Proven track record of creating, establishing and maintaining strategically focused Quality functions.
- Bachelor’s degree, Master’s degree or PhD in science, pharmaceutical sciences or related field
- Minimum 15 years of experience in Quality Assurance with at least 7 years of experience in GxP Quality supporting pharmaceutical development, manufacturing, and testing
- Proven track record of critical thinking, flexibility, innovation, including the ability to manage priorities, track progress of key projects, and provide updates to leadership as required.
- Thorough knowledge of preclinical, clinical and commercial product development. Post-market experience a plus. Technical knowledge of analytical method qualification, process validation and establishing product specifications.
- Experience with outsourced manufacturing and testing operations
- Experience in working in compliance with US, EU and ICH GMP requirements, experience reviewing submission documentation, responses to regulatory inquiries and inspections
- Preferred experience with personalized medicines and nucleic acid-based and/or gene therapies
- Demonstrated ability to work independently, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
- Excellent oral and written communication.
- Strong interpersonal skills to effectively communicate with teams, peers, management and external contacts.
- Proven organizational and leadership skills to mentor and develop team to achieve Company goals. Demonstrated ability to effectively lead professional staff
- Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project.
- Must exhibit organizational skills
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.