Senior Director, Head of Quality Systems and Compliance
About the role
Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Senior Director, Head of Quality Systems and Compliance, you will report to VP, Head of Quality of Technical Operations, to lead the Sana Quality Management Systems and Compliance teams to ensure high degree of compliance and effectiveness.
What you'll do
- Manage Sana GMP Quality Management Systems
- Develop and report on quality performance metrics
- Participate in building, deploying, managing, and training of quality system processes
- Manage, host, and facilitate Health Authorities and Partners inspections
- Manage internal and external audit programs
- Maintain current knowledges of US/EU regulations, guidelines, and industry standards for Quality Systems and Cell and Gene Therapy products
- Engage in crucial conversations by providing and receiving feedback supporting the growth and development of team members
- Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
- Drive curiosity, scientific rigor, and excellent problem-solving skills across a fast-paced performance driven environment
- Innate ability to assess talent that will help grow the organization and add to Sana's culture
What we're looking for
- Familiar with US, EU, and ICH regulations and guidance documents
- Confirmed leadership in implementing Quality Management Systems for a multi-site biopharmaceutical company
- Knowledge and competence in Quality processes, including change control, discrepancy, CAPA, risk management, and training.
- Bachelor's degree in life-scientific discipline
- 12+ years of experience working in the biopharmaceutical GMP functions
What will separate you from the crowd
- Experience in implementing eQMS
- Experience in Cell and Gene Therapy Product
What you should know
- Working safely in person on a predictable and regular in-person basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19, including receipt of a vaccine booster shot if recommended by the CDC
How we work together
- 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 diverse workforce 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 100% of the cost for employee health coverage and offer generous time-off, 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.
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.