Associate Director Quality Systems
4 weeks ago
Sana Biotechnology manufacturing facility in Bothell, WA, is hiring new team members who believe in the potential of engineered cells as medicines, dedicated to quality, and passionate about delivering the possible to patients.
As the Associate Director of Quality Systems, you will report to the Executive Director of Quality at the Bothell site. This role is critical in establishing and maintaining the Quality systems at the manufacturing site. This role is required to be onsite in Bothell, WA.
What you'll do
- Provide leadership in deploying Quality systems for the facility start-up, including systems such as Deviation and CAPA management, Change Management, Training administration, and Document and Records Management
- Establish site metrics for Quality System Health indicators as part of Management Review
- Support deployment of risk management and data integrity programs at the site
- Serve as a subject matter expert for Health Authority inspections and internal audits
- Support administrator of the Document Change Control process for GMP documents
- Support administrator of Training program for GMP personnel at the site
- Establish the site Document Control room to manage issuance of controlled documents and retention of executed GMP records
- Collaborate with global Quality to coordinate delivery of training for Quality systems, including Deviation and CAPA management and change management processes
- Implement Quality Management Review requirements to meet US and EU regulatory expectations
- BA or BS in life science degree
- 8+ years of experience in the pharmaceutical or biotechnology industry in Quality Assurance or Quality Systems or equivalent combination of education and work experience
- Demonstrated experience in Quality System functions within a GMP facility of cell/gene therapy products or biologics in both clinical and/or commercial settings
- Previous experience in Quality Management Systems (Document Management, Records Management, Deviations, CAPAs, Change Control, Risk Management, OOS/Laboratory Investigations, Material Review Board, Quality Management Review)
- Ability to effectively prioritize and deliver high-quality results on tight timelines
- Excellent written, verbal communication and presentation skills
- Previous experience working in facility start up projects, and maturation of systems
- Previous experience interacting with Health Authority investigators
- Cell and Gene Therapy product experience
- Experience working in the Veeva platform
- The role is located in Bothell, WA at the Bothell manufacturing site
- The base pay range for this position at commencement of employment is expected to be between $160,000 and $200,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
- 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'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.
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