Associate Director, Quality Operations
1 week ago
About the roleSana 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 Operations, you will report to the Executive Director of Quality at the Bothell site.
This role is critical in providing Quality oversight for establishing procedures at the startup of the Bothell manufacturing facility and ultimately ensuring successful execution and maintenance of the established process and procedures.
This role supports Manufacturing, Laboratory and Warehouse Operations and is required to be onsite in Bothell, WA.What you'll doProvide leadership for Quality oversight for the facility start-up, including support for the establishment of Manufacturing, Laboratory and Warehouse operationsEstablish process and procedures for batch record reviewSupport risk management activities and approve risk management reportsServe as a subject matter expert for Health Authority inspections and internal auditsEstablish and execute material and product disposition activities, in compliance with US and EU requirementsSupport new product introduction activities, including Quality oversight of tech transferCollaborate with global Quality Validation to support oversight of facilities and engineering related processes for equipment, facilities and utilities, post qualification.
Post facility qualification will also require:
Quality oversight activities for deviations, CAPAs and change controlsManaging and assessment vendor-initiated changes impacting the siteManage performance and development of direct reportsWhat we're looking forBA or BS in life science degree8+ years of experience in the pharmaceutical or biotechnology industry in Quality Assurance or Quality Systems or equivalent combination of education and work experienceDemonstrated experience in Quality Operations functions within a GMP facility of cell/gene therapy products or biologics in both clinical and/or commercial settingsPrevious experience in Quality Operations, in start up or operational settingAbility to effectively prioritize and deliver high-quality results on tight timelines.
Extensive knowledge of cGMPsExcellent written, verbal communication and presentation skillsResilient leader and willing to collaborate across cross functional teamsWhat will separate you from the crowdPrevious experience working in facility start up projects, and maturation of systemsPrevious experience interacting with Health Authority investigatorsCell and Gene Therapy product experienceExperience working in both electronic and manual systemsWhat you should knowThe role is located in Bothell, WA at the Bothell manufacturing siteMay need to successfully pass and maintain aseptic gowning qualifications.
Aseptic gowning requires that all skin and hair be covered through wearing the following:beard/mustache cover, hair net, hood and facemask, goggles, jumpsuit, gloves, and bootsMust be able to successfully pass all job-related tests and certifications required for working in a cGMP, quality environment including but not limited to: inspections and GMP requirements to perform essential functions of the jobThe 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 experienceHow we work together for patientsLead from every seat - we seek to understand, act with honesty, and engage in the crucial conversationsThrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivityMake it happen - we value vigorous debate, alignment around our decisions, and resilient executionGet to know usAt 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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