Beam Therapeutics is seeking an experience individual to lead and develop our Quality department. The ideal candidate will help shape and drive Quality Operations culture, fostering a proactive, phase appropriate quality focused approach, with close partnership and understanding of key stakeholders including Quality Systems, Analytical Development and the CMC Development and Supply Chain functions. This hire will serve as a head Quality Lead and will contribute to Beam’s Regulatory Operations and QA/QC, as well as interactions with regulatory authorities. If you are passionate about providing critical therapies and want an opportunity to grow and lead a Quality function with established and dynamic thought leaders, then this is the opportunity for you.
Primary Job Responsibilities:
- Define and implement a quality assurance strategy that is aligned with company objectives, including a clear vision for the structure and role of the Quality Assurance and Quality Control functions.
- Develop, implement, maintain and continually assess a quality department and a quality management system for applicable regulated activities to meet internal company standards and external requirements.
- Responsible with providing quality oversight and support contract manufacturers across all phases of development and commercial.
- Serve as the lead for compliance with GXP (e.g., GLP, GCP and GVP) requirements for multiple products.
- Define and manage Quality departmental budget to support company objectives.
- Provide regulatory operations support of product development including registration strategies, including broad regulatory oversight for CMC, Nonclinical/Clinical Development.
- Build partnerships with cross-functional key groups to ensure that strategic business goals are met through the sharing of knowledge and expertise.
- Ensure high-quality and timely regulatory submissions (IND, IMPD, NDA, and BLA, as applicable) in compliance with all applicable regulatory requirements (ICH Module 1 through 5) and in alignment with corporate goals. Secure worldwide regulatory approvals for the company’s products in conformity with global and regionally specific requirements.
- Contribute to interpreting FDA and other regulatory laws and standards, and subsequently update the company’s QMS and regulatory practices as necessary to ensure continuous operational compliance.
- Monitor, investigate and ensure resolution of quality problems with products, processes, and/or the QMS.
- Oversee internal and external quality audits and work closely with team members and external partners to reinforce adherence to company standard operating procedures.
- Oversee release of the company’s products for distribution and ensure that all released products meet their specifications.
- Contribute to review and approval of product labeling and packaging to ensure that they conform to regulatory requirements.
- Support planning and execution of clinical trials in support of regulatory filings in accordance with Good Clinical Practices (GCP).
Primary Job Requirements:
- Required 10-12+ years of experience in quality systems/regulatory affairs, with a minimum 3-5 years of leadership/management experience working with biologic programs, preferably within oncology studies.
- Strong expertise of US, Asian and EU regulations.
- Working knowledge of Current Good Clinical Practice (CGCP) and Current Good Manufacturing Practice (CGMP) required. Current Good Laboratory Practice (GCLP) is a plus.
- Preferred experience with working and dealing with regulatory agencies (FDA, EU, and Asia).
- Excellent verbal, written and presentation skills, including presenting timelines, risks & budgets to Senior Leaders in companies
- Experience coordinating and creating documentation for regulatory submissions (IND, BLA, and NDA), or other international applications.
- Ability to communicate with highly specialized scientists, and other cross-functional thought leaders (Clinical Operations, CMC, Project Management, Legal).
- Must have experience managing and mentoring people
- Ability to travel up to 20%.