Senior Director, Quality Control
Found in: Jooble US O C2 - 2 weeks ago
About the role
Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of cells and viruses as engineered medicines, who want to challenge status quo, and lead with the desire to work on novel ideas. As the Bothell Sr. Director Quality Control, you will report to the Executive Director, Site Quality Head, Technical Operations, to provide the Quality Control oversight on the facility startup, qualification and validation activities, and the routine analytical product and in-process controls at the site.
What you’ll do
- Provide Quality Control oversight for the facility startup, including qualification and validation activities
- Build GMP quality systems and the compliance infrastructure for the Quality Control labs
- Oversee lab instrument qualifications and test method transfers and qualifications
- Establish and maintain analytical assay performance trending program and reference standard trending program. Approve reports as per schedule
- Oversee management of product and materials stability programs
- Establish test reagent and materials inventory management process to ensure testing execution to planned schedules
- Oversee equipment and instrument maintenance and calibration program to ensure testing execution to planned schedules
- Manage the critical utilities monitoring program for the production facility and labs
- Oversee material qualification program including materials risk assessments
- Lead inspections by FDA, or other regulatory agencies for Quality Control topics
- Serve as Business Process Owner for LIMS implementation
- Manage to a high level of efficiency in lab execution by adopting strong interdepartmental communications and lean labs processes.
- Manage and mentor staff to ensure a high performing team
- 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
What we’re looking for
- Familiarity with the US, EMA, and ICH regulations and guidance documents and USP, EP and JP
- Good working knowledge of analytical and bioanalytical assays
- Demonstrated ability to engage team members across diverse teams
- Promote curiosity, scientific rigor, and excellent problem-solving skills
- Experience implementing Quality/Compliance systems
- Collaboration skills
- Experience with Project Management and Analytics software
- BA or BS in life science or biochemistry degree
- 12+ years' experience in the pharmaceutical or biotechnology industry in a Quality Control, Analytical Development, Quality or Compliance function managing department teams
What will separate you from the crowd
- Cell and Gene Therapy product experience
- Successful facility startup and regulatory inspection experience
- Experience with flow cytometry, bioassays, molecular biological assays and microbiological assays
What you should know
- Work may involve aseptic gowning for activities in the cleanroom
- There may be potential exposure to BSL2 biohazardous materials that are handled in the laboratories
- There may be exposure to disinfectants that are used in cleanrooms and environmental microbial organisms from routine product and environmental testing
- The role will be located in Seattle, WA until the Bothell manufacturing site is ready for occupancy
- The base pay range for this position at commencement of employment is expected to be between $230,000 and $270,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
-
Senior Director, Quality Control
7 days ago
Seattle, United States CareerBuilder Full timeAbout the role Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of cells and viruses as engineered medicines, who want to challenge status quo, and lead with the desire to work on novel ideas. As the Bothell Sr. Director Quality Control, you will report to the Executive Director, Site Quality Head, Technical...
-
Quality Control Manager
4 days ago
Seattle, United States MRINetwork Jobs Full timeJob Description Job Description Quality Control ManagerLocation: Seattle, WA (hybrid)Ref No: 1382We are currently working with a leading consumer goods organization recognized globally for their commitment to quality. As they look to enhance the experience on their team, they are looking to add a Quality Control Manager. This is a hybrid role in office 2...
-
Quality Control Manager
6 days ago
Seattle, United States MRINetwork Jobs Full timeJob Description Job Description Quality Control Manager Location: Seattle, WA (hybrid) Ref No: 1382 We are currently working with a leading consumer goods organization recognized globally for their commitment to quality. As they look to enhance the experience on their team, they are looking to add a Quality Control Manager. This is a hybrid role – in...
-
Director Quality Assurance
Found in: Jooble US O C2 - 2 weeks ago
Seattle, WA, United States Undercurrentnews Full timeAqua Star is a privately-owned, American seafood company headquartered in Seattle, Washington. Founded in 1990 by seafood experts who still manage the business today, we are a part of a Family of companies that is collectively one of the largest seafood companies in the world. Position Summary: Aqua Star (USA) Corp. is looking to fill the role of a...
-
Quality Document Control Specialist
4 hours ago
Seattle, United States Integrated Resources, Inc ( IRI ) Full timeJob Title: Quality Assurance Document Control SpecialistJob Location: Seattle, WAJob Duration: 12 Months+ Job Description: Top Skills:- 2+ years of Document Control & Reporting Experience,- Veeva experience preferred- Technical troubleshooting- Self motivated, independent, great communication- Experience working cross-functionallyPosition Summary:The...
-
Seattle, United States Artech Inc Full timeJob Description: Top Skills: - 2+ years of Document Control & Reporting Experience, - Veeva experience preferred - Technical troubleshooting - Self motivated, independent, great communication - Experience working cross-functionally Position Summary: The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control...
-
Senior Director, People Partner
Found in: Jooble US O C2 - 2 weeks ago
Seattle, WA, United States Moloco, Inc. Full timeThe Impact You’ll Be Contributing to Moloco: As the Sr. Director People Partner, you'll spearhead our mission to foster an inclusive and empowering workplace culture. Reporting directly to our Chief People Officer, you'll partner closely with senior leaders, particularly in Engineering, to craft and execute innovative People and culture...
-
Senior Quality Control Microbiology Manager
1 week ago
Seattle, United States CareerBuilder Full timeQuality Control Microbiology Manager page is loaded Quality Control Microbiology Manager Apply locations Redmond Seattle time type Full time posted on Posted Yesterday job requisition id JOB ID-10496 Just is seeking a highly motivated individual who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for someone...
-
Regional Vice President of Operations
1 week ago
Seattle, United States Cogir Senior Living Full timeJob DescriptionJob DescriptionBringing people together in unique ways to enliven and enrich lives.What to expect...Cogir Senior Living seeks a Regional Vice President of Operations (Regional Director of Operations) to oversee a portfolio of senior living communities in our Washington Region. We welcome candidates from the hospitality (luxury hotel or resort...
-
Director, Architecture
Found in: Jooble US O C2 - 2 weeks ago
Seattle, WA, United States Ware Malcomb Full timeWare Malcomb has an exciting opportunity for a Director to join our senior leadership team in Seattle, WA! TheDirector is a key member of the Ware Malcomb senior management team, responsible for supporting the Principal in the areas of growth, revenue, profitability, staff management and client relationships for the Los Angeles market. You will be...
-
Senior Director of Clinical Programs
1 day ago
Seattle, United States Downtown Emergency Service Center Full timeJob Description Job Description Description: Shift: Office DayDays Off: Saturday and SundayInsurance Benefits: Dental, Life, Long-term Disability, Medical (no premiums/payroll deductions for employee coverage)Other Benefits: Employee Assistance Program (EAP), Flexible Spending Account (FSA), ORCA card subsidy, Paid Time Off (34 days per year), Retirement...
-
Director Quality Assurance
2 days ago
Seattle, United States Undercurrentnews Full timeAqua Star is a privately-owned, American seafood company headquartered in Seattle, Washington. Founded in 1990 by seafood experts who still manage the business today, we are a part of a Family of companies that is collectively one of the largest seafood companies in the world. Position Summary: Aqua Star (USA) Corp. is looking to fill the role of a Director...
-
Senior Director, Clinical Pharmacology and Pharmacometrics
Found in: Jooble US O C2 - 2 days ago
Bothell, WA, United States Immunome Inc Full timeJob Title: Senior Director, Clinical Pharmacology and Pharmacometrics Immunome is a biotechnology company dedicated to developing first-in-class and best-in-class targeted cancer therapies. Our portfolio pursues each target with a modality appropriate to its biology, including immunotherapies, targeted effectors, radioligand therapies and antibody drug...
-
Senior Director of Clinical Programs
2 days ago
Seattle, United States CareerBuilder Full timeJob Description Job Description Description: Shift: Office Day Days Off: Saturday and Sunday Insurance Benefits: Dental, Life, Long-term Disability, Medical (no premiums/payroll deductions for employee coverage) Other Benefits: Employee Assistance Program (EAP), Flexible Spending Account (FSA), ORCA card subsidy, Paid Time Off (34 days per year), Retirement...
-
Senior Quality Manager
7 days ago
Seattle, United States Sellen Construction Full timeDescription Envision Yourself as a Senior Quality ManagerThe Senior Quality Manager oversees the delivery of Sellen's Quality Management Program, while partnering with project teams to ensure effective implementation. The role promotes, coaches, and trains on quality implementation and continuous improvement efforts in the delivery of quality strategies and...
-
Quality Assurance Document Control
Found in: Appcast US C2 - 1 week ago
Seattle, United States Cynet Systems Inc. Full timeEducation and Experience: Bachelor’s degree or equivalent. Minimum of 1 year of relevant document control experience in a cGMP/FDA regulated environment. Strong communication and customer service skills. Some technical writing skill set including the ability to critically review documents while effectively inputting and expressing Quality...
-
Senior Director of Clinical Programs
1 week ago
Seattle, United States Downtown Emergency Service Center Full timeJob DescriptionJob DescriptionDescription:Shift: Office DayDays Off: Saturday and SundayInsurance Benefits: Dental, Life, Long-term Disability, Medical (no premiums/payroll deductions for employee coverage)Other Benefits: Employee Assistance Program (EAP), Flexible Spending Account (FSA), ORCA card subsidy, Paid Time Off (34 days per year), Retirement PlanTo...
-
Senior Quality Manager
Found in: Talent US C2 - 1 week ago
Seattle, United States Sellen Construction Full timeDescription Envision Yourself as a Senior Quality Manager The Senior Quality Manager oversees the delivery of Sellen's Quality Management Program, while partnering with project teams to ensure effective implementation. The role promotes, coaches, and trains on quality implementation and continuous improvement efforts in the delivery of quality...
-
Senior Director of Supply Chain
Found in: Jooble US O C2 - 2 weeks ago
Seattle, WA, United States NW Harvest Full timeJob DescriptionJob DescriptionPOSITION SUMMARY: The Senior Director of Supply Chain (SDSC) engageswith Northwest Harvest’s goal of cutting hunger rates in half by 2028 by: being a forward-looking systems thinker, a creative and adaptive leader focused on measurable, cost-effective results, and a strategic partner to leaders in the Supply Chain (SC)...
-
Director of Health Services
1 week ago
Seattle, United States MBK Senior Living Full timeThe Director of Health Services (DHS) embodies Yoi Shigoto, the good work, by leading the overall implementation of health and wellness services in the community. The DHS serves as a liaison with families, hospital personnel, physicians, community or Director, Health, Care Director, Service, Wellness, Dance, Healthcare