Sr. Director, Clinical and Pre Clinical Quality Assurance
$240k - $310k USD
About the role
Sana Biotechnology is a company that believes in the potential of engineered cells as medicines and is composed of a team that wants to lead with the desire to work on novel ideas. Sana is developing cell and gene therapies in type 1 diabetes, autoimmune disease, and oncology. As a Senior Director, you'll report to the Chief Medical Officer. You will lead Quality projects and set Quality expectations for GLP- and GCP-regulated work to ensure compliance with applicable regulations and standards.
The Senior Director of Quality (GLP/GCP) will be responsible for the strategic approach to Quality that is phase appropriate. You will design, prioritize, implement, monitor, and communicate Sana's GLP/GCP quality strategy and quality programs. Further, you will establish and translate Sana's quality strategy into operational policies and procedures and training to meet global regulatory, medical/health, and legislative standards. We are looking for the experience, knowledge, and leadership credibility to be effective across Sana in multiple capacities, thereby ensuring compliance with Quality standards and corporate-wide commitment to Quality principles.
The role is working from Cambridge, MA – in the office 3 days a week. Some travel may be required.
What you will do:
- In this highly visible role, you will oversee Quality-related activities that support non- clinical and clinical work.
- Provide senior-level leadership regarding GLP/GCP quality strategy and operations for leadership and cross-functional project teams.
- Oversee GLP quality and compliance of GLP bioanalysis.
- Review clinical study protocols and reports, and regulatory submissions.
- Manage and sustain a Quality Management System (QMS) that conforms to corporate standards and regulatory requirements and effectively implements this system across Sana.
- Provide leadership in the execution and management of the following:
- GLP and GCP audits (internal sites, clinical sites, CROs, contract test labs and contract service providers)
- Vendor qualifications and vendor management, including:
- Approval of Quality agreements.
- Collaboration and resolution of complex issues on supplier, partner, vendor performance.
- Quality investigations (QE, Deviation, CAPA),
- Review and approval of documents and
- Administration of training programs.
- Support program teams by providing direction on interpretation of global quality regulations and guidance documents.
- Identify, assess and mitigate potential challenges that could impact overall quality.
- Ensure Sana practices are compliant with regulatory requirements (FDA, ICH (R3), EMA) and industry standards.
- Establish and maintain procedures in collaboration with Development, Clinical Operations, Regulatory Affairs, and Technical Operations to ensure the nonclinical/clinical study activities are conducted according to GxP compliance regulations, guidelines, and practices.
- Identify and administers training needs related to GLP/GCP training for SOPs, policies, and clinical study specific training for GLP/GCP employees and ensure comprehensive training is provided to support compliance.
- Design, implement and maintain Quality systems that promote continual improvement of GLP/GCP
- Generate and analyze key performance metrics on a quarterly basis to track performance against quality objectives and standards, and report during quality management review meetings with leadership.
- Provide GLP/GCP quality guidance and partner with key stakeholders to resolve quality compliance issues and support with quality event management, protocol deviations, risk management, issue escalation and CAPA development. Ensure suitability of corrective and preventive actions, verifying CAPAs to completion and keeping management informed of CAPA metrics.
What we're looking for
- Bachelor's degree required, advanced degree in relevant scientific field is a plus
- 8+ years of relevant experience within biotechnology or pharmaceutical industry; including in development of complex biologics (such as gene therapy, vaccines, monoclonal/conjugated antibodies, enzyme replacement therapies), and small molecules
What will separate you from the crowd
- Collaborate well with all functional groups that Quality interacts, including CMC Quality
- Ability to adeptly prioritize key items among a myriad of quality-related activities
- Thorough understanding of industry regulatory environment related to Quality Systems; ability to evaluate complex situations and to provide practical perspectives/options for evaluating regulatory, financial, or legal risks and mitigations especially where compliance guidelines are inadequate.
- Be highly effective having difficult conversations on a routine basis internally or externally with partners; must be able to preserve the relationship while confronting quality issues that create unacceptable risks for Sana
- Is intellectually curious, innovative, creative, practical/flexible, and remain calm under challenging situations
What you should know
- The base pay range for this position at commencement of employment is expected to be between $240,000-$310,000 annually; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
How we work together for patients
- Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
- Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
- Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution
Get to know us
At Sana, we believe that a workforce with varied backgrounds strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.
Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover a generous portion of the cost for employee health coverage, making high-quality care more accessible and affordable. We offer ample time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana’sBenefits Portal.
We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.
To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.