7 Jobs in Bothell, WA
Biospace is Hiring an Associate Director, Quality Operations (Bothell) Near Bothell, WA
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 Do
- Provide leadership for Quality oversight for the facility start-up, including support for the establishment of Manufacturing, Laboratory and Warehouse operations
- Establish process and procedures for batch record review
- Support risk management activities and approve risk management reports
- Serve as a subject matter expert for Health Authority inspections and internal audits
- Establish and execute material and product disposition activities, in compliance with US and EU requirements
- Support new product introduction activities, including Quality oversight of tech transfer
- Collaborate 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 controls
- Managing and assessment vendor-initiated changes impacting the site
- Manage performance and development of direct reports
- 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 Operations functions within a GMP facility of cell/gene therapy products or biologics in both clinical and/or commercial settings
- Previous experience in Quality Operations, in start up or operational setting
- Ability to effectively prioritize and deliver high-quality results on tight timelines.
- Extensive knowledge of cGMPs
- Excellent written, verbal communication and presentation skills
- Resilient leader and willing to collaborate across cross functional teams
- 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 both electronic and manual systems
- The role is located in Bothell, WA at the Bothell manufacturing site
- May 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 boots
- Must 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 job
- 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
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.
Job Summary
Full Time
Scientific Services
$176k-216k (estimate)
06/04/2024
06/23/2024
biospace.com
CERRITOS, CA
50 - 100
1985
KI CHUL CHA
$10M - $50M
Scientific Services
Related Companies
About Biospace
BioSpace serves as the leading online source for biotechnology jobs, breaking industry news and expert analysis. BioSpace has accelerated recruitment, communication and discovery among business and scientific leaders within the life sciences for more than 30 years.
The job skills required for Associate Director, Quality Operations (Bothell) include Leadership, Quality Assurance, Presentation, Risk Management, Alignment, etc. Having related job skills and expertise will give you an advantage when applying to be an Associate Director, Quality Operations (Bothell). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Associate Director, Quality Operations (Bothell). Select any job title you are interested in and start to search job requirements.
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