Quality Systems Manager
- San Francisco, CA
Over the coming years, biotech will fundamentally rewrite the way we live. Gene editing and cell therapy are dramatically changing how we treat cancer and other major illnesses. Biofuels and biomaterials are transforming the cars we drive, the clothes we wear, and the makeup of everyday objects. Crop science and synthetic biology are producing sustainable and ethical food. Benchling’s mission is to accelerate the research that propels us towards this reality, and magnify its impact, through modern software.
Every day, scientists around the world use Benchling’s applications, platform, & analytics in their efforts to solve humanity’s most pressing problems. For these scientists, Benchling is the central technology they use to conduct their research. Our customers include pharmaceutical giants, leading biotechs, and the world’s most renowned research institutes.
As a Quality Systems Manager you will have a hands-on role helping to establish our Quality Management System for Benchling. You'll work with agile teams to implement new & existing Standard Operating Procedures by which we design, verify, and validate our products, manage risk and execute as an organization. You'll work collaboratively across functional areas in the development, maintenance, and continuous improvement of Benchling's quality processes.
WHAT YOU WILL WORK ON
- Manage quality system processes such as Change Control, Document Control, Regulatory Assessments and CAPA in support of Benchling’s GxP offering.
- Author and revise standard operating procedures and work instructions. Maintain updated knowledge and relevant assessments of the GxP landscape, regulations, and guidelines.
- Ensure policies, procedures and compliance documentation conforms to applicable standards and guidelines through periodic review and internal audits.
- Generate metrics, reporting, and documentation in support of a continuously improving QMS in alignment with FDA and ISO guidelines.
- Provide quality oversight for qualification and validation activities including protocol generation, execution, and final report documentation. Approve IQ/OQ/PQ protocol and reports.
- Establish and maintain formal document management and change control systems for GXP related activities. Review and approve change controls related to the product upgrades, system changes and documentation changes.
- Design, implement, and maintain the nonconformance and CAPA management system.
- Collaborate with other departments for investigations and determination of root cause.
- Oversee the execution and completion of CA or PA activities.
- Identify opportunities for improvement, and drives continuous improvement initiatives.
- Support external audits in support of customers’ GxP compliance as needed.
- Mentor junior team members in validation and quality teams.
- B.S. in Life Sciences or Engineering with 9+ years of Life Sciences Quality and Compliance experience
- Strong understanding of regulatory requirements around FDA 21 CFR Part 11, EU Annex 11, GAMP 5, GLP and GMP regulations as well as ISO 9001 QMS requirements
- Experience working with lab systems (ELN, LIMS, SDMS) and process in a GxP environment is highly desirable
- Have hands-on working knowledge and passion for modern quality tools and agile approaches
- Ability to thrive in a fast-paced dynamic environment with the ability to maintain objective and autonomous as it relates to quality and compliance
- Experience as a Quality Systems Manager at a medical, biotech, pharma or equivalent
Benchling welcomes everyone. We believe every member of our team enriches our diversity and inclusion by broadening our ways of problem-solving for future challenges. Even if you don't meet 100% of the qualifications for this job, we strongly encourage you to apply.
- Admit mistakes and shortcomings
- Deliver results
- Disagree and commit
- Obsess over customers
- Rely on work ethic
- Show empathy
- Recruit and develop the best
- Sweat the details
- Think and communicate clearly
- Unite around the mission
PERKS AND BENEFITS
- Work with a talented yet humble team
- Competitive compensation & equity package
- Quarterly mental health days
- Weekly virtual social events, and annual company retreats
- 401k, Medical, dental, and vision insurance (US Employees Only)
- Monthly health & wellness stipend (Currently US Employees Only)
- Yearly educational stipend (Currently US Employees Only)
- To support remote work conditions, Benchling provides each employee a one-time stipend of $1,000(USD) upon commencing employment, and additional discounted employee purchase plans for home-office equipment.
In following best practices and safety protocols, all Benchling employees are expected to work remotely until we are further advised that it is safe for employees to resume work in their respective office locations.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We also consider for employment qualified applicants with arrest and conviction records, consistent with applicable federal, state and local law, including but not limited to the San Francisco Fair Chance Ordinance.
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