Senior Manager, GMP QMS

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 the Senior Manager, GMP QMS, you will report to the Senior Director, Head of Quality System and Compliance to manage GMP suppliers, internal audits, and quality management system activities.  This includes the qualification of GMP suppliers, performing internal audits, conducting investigations, implementation of corrective/preventive actions, evaluating change controls, and performing risk management. You will also support 21 CFR Part 11 DocuSign administration and Veeva QualityDocs administration.

What you'll do

• Qualify and manage GMP suppliers, including performing audits, audit reports, training auditors, following up with suppliers for addressing observations from audits, send questionnaires and review responses, maintain approved supplier lists and audit schedule   
• Perform internal audits of Sana’s GMP activities.  Work with team members to develop areas for improvement from audit findings and assure implementation
• Lead and conduct investigations for deviations, laboratory investigations, out-of-specification investigations, and quality issues
• Lead risk management activities, including risk assessments
• Support 21 CFR Part 11 DocuSign administrator for electronic signature of GMP documents
• Support Veeva Quality Docs administrator for document control routing of GMP documents
• Support GMP Training administrator of Veeva Training for training matrices and curricula.

What we're looking for

• BA or MS plus 8 yrs or equivalent combination of education and work experience
• Previous experience in supplier management process. Minimally, 5 years in a pharmaceutical environment, may be either an auditor or established a supplier management program
• Previous experience in internal audit program. Minimally, 5 years in a pharmaceutical environment, may be either a qualified internal auditor or have previously established an internal audit program
• Minimum of 8 years of pharmaceutical experience in Quality. Minimum experience in quality management systems (Deviations, CAPAs, Change Control, Risk Management, OOS/Laboratory Investigations, Material Review Board, Quality Management Review, Internal Audits, and Supplier Management) of 5 years with a combination experience in quality assurance and/or quality control of 4 years

What will separate you from the crowd

• Previous experience working with multiple disciplines in projects assuring agreement
• Previous experience working environments with minimum or non-established processes.
• Previous experience working in a matrix environment

What you should know

• Travel is no more than 50% for domestic and international
• You are located in South San Francisco and is hybrid
• Lift of approximately 15 lbs. such as documents, binders, and laboratory notebooks.
• Typing for extended periods on a computer screen
• Potential exposures to biological hazards, chemicals, and viruses
• Working safely in person on a predictable and regular 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
• The base pay range for this position at commencement of employment is expected to be between $160,000 and $180,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience

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 (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’s Benefits 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.