Sana Biotechnology, Inc. · 3 days ago
Sr. Director, Clinical and Pre Clinical Quality Assurance
Cambridge, MA
Full-time
Hybrid
Director/Executive
$240K/yr - $310K/yr
8+ years expSana Biotechnology is a company focused on developing cell and gene therapies. The Senior Director will lead Quality projects, ensuring compliance with GLP and GCP standards, and will be responsible for designing and implementing the quality strategy across the organization.
BiotechnologyHealth CareLife ScienceProduct Research
Responsibilities
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 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
Qualification
Required
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
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 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
Preferred
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
Benefits
Employee health coverage
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
A variety of wellness offerings to support each person individually
Company
Sana Biotechnology, Inc.
Sana Biotechnology is focused on utilizing engineered cells as medicines for patients.
201-500 employees
H1B Sponsorship
Sana Biotechnology, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (17)
2024 (15)
2023 (8)
2022 (24)
2021 (8)
2020 (8)
Funding
Current Stage
Public CompanyTotal Funding
$951.3M2025-08-06Post Ipo Equity· $86.3M
2024-02-07Post Ipo Equity· $165M
2021-02-04IPO
Leadership Team
Steve Harr
President and Chief Executive Officer
Richard Mulligan
Vice Chairman and Head, Sana X
Recent News
Longevity.Technology - Latest News, Opinions, Analysis and Research
2025-12-10
2025-12-09
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