Role:
Be Bio is seeking an experienced and motivated Senior Director, Quality Assurance, to establish our Quality Assurance team in support early phase clinical activities.
The Sr. Director, Quality Assurance will be responsible for implementing GxP (GCP/GLP/GMP) compliant Quality Management Systems, performing all required functions of the Quality Unit (ie product release) and building a Quality Assurance organization that fosters a strong Quality culture at Be Bio. This position will partner equally with both internal and external stakeholders and partners (CROs, CDMOs).
Responsibilities:
- Responsible for the strategic development and execution of Be Bio’s quality assurance programs.
- Responsible for all independent, quality-related decisions
- The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement focused on delivering efficiencies and maximizing Be Bio’s platform
- The role requires expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and relevant regulations across multiple jurisdictions
- Collaborate with cross functional internal teams to evaluate processes, procedures and activities for adherence to relevant industry standards, regulatory guidelines and company Standard Operating Procedures (SOPs) as appropriate
- Establish and manage Quality and Compliance Training program for GxP employees and contractors
- Accountable for overall quality and compliance oversight to include manufacturing, supply chain, nonclinical, and clinical functions.
- Establish GxP Vendor Qualification program in accordance with regulatory expectations.
- GxP vendor Quality oversight, including product batch records, manufacturing investigations, vendor product release, stability programs, analytical method qualifications, etc.
- Ensures robust Patient Traceability COC/COI process for autologous cell therapy programs
- Ensures quality metrics comply with best industry standards and practices, and maintains effective quality governance and continually improves governance to meet organizational and compliance needs
- Interprets and applies quality requirements and provides guidance and training to ensure that company and its GxP vendors maintain an ongoing state of compliance
Experience, Education, Specialized Knowledge, and Skills:
Must thrive in a fast-paced, growing, and innovative environment where flexibility, resourcefulness, resiliency, and communication skills are key. Excellent interpersonal skills, ability to develop important relationships with your stakeholders, and being an all around good company citizen are essential.
- BS/BA in Chemistry, Biology, Pharmaceutics, or other science related field with at least 15 years’ experience in pharmaceutical / biotech industry within Quality Assurance or Quality (Assurance) exposure
- Prior cell therapy and/or gene therapy experience
- Knowledge of FDA, EU, ICH requirements for GLP and related areas, e.g., 21 CFR Part 58, Part 11 / Annex 11, OECD Principles of Good Laboratory Practices and GLP Compliance Monitoring, etc
- Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in leading successful regulatory international inspections
- Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way
- Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others
- Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations
- Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment
- Ability to be agile and effectively collaborate in a dynamic, cross-functional environment
About Be Biopharma
Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BCM) to dramatically improve patients’ lives who are living with cancer, rare diseases and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020 by Longwood Fund and B cell engineering pioneers David Rawlings, M.D., and Richard James, Ph.D. from Seattle Children’s Research Institute. Be Bio is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb and Takeda Ventures. Since our founding, Be Bio’s investors have committed over $180 million to enable the Company to re-imagine medicine based on the power of B cell therapy. For more information, please visit us at Be.Bio and our LinkedIn page.
Culture
The beating heart of Be Bio is our People and together we are building a culture driven by purpose, passion, and that’s full of character. We are “all-in” as we align ourselves with patients who need our medicines, and we embrace the highest standards of transparency, excellence, candor, collaboration, and team-based science with a shared ownership of company milestones and successes.
Our commitment to our team members is to deliver a compelling, dynamic work experience that enables them to continually stretch, grow, and learn, that enriches their lives, that fosters a sense of belonging and community, and that goes above and beyond to support them in big, meaningful ways in both their personal and professional lives. Be Bio is a team that works hard, plays hard, and supports each other on our shared journey to get transformative medicines to patients who need them.
