Senior Manager, QA Validation Engineer

Location
South San Francisco, California, United States
Posted
Jul 20, 2021
Ref
1448327862
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Thank you for your interest in a career at Senti Biosciences. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. We are passionate about designing gene circuits to improve the "intelligence" of cell and gene therapies in order to enhance their therapeutic effectiveness against a broad range of diseases that conventional medicines are unable to address.

At Senti, we find purpose and meaning knowing that our efforts have the potential to improve the lives of patients and their families with more effective and safer treatment options. With science as our foundation and empathy as our key guiding principle, colleagues become friends, managers become mentors, and with time, cancer becomes history.

We are currently recruiting for Sr. Manager, QA Validation Engineer, reporting to Sr. Director, Quality. The ideal candidate is an experienced QA Engineer with a track record of success in GMP clinical and commercial environments and understands biologics and/or cell therapy processes to provide QA oversight for qualification and validation lifecycle.

Responsibilities
    • QA oversight for all validation and qualification activities (facility, cleaning, equipment, & software) including but not limited to review and approval of protocol, summary reports, URS, FRS, Traceability Matrix, and all other related documents.
    • Act as QA SME to support validation/qualification projects
    • Manage deviation investigations, as needed.
    • Implement Change Control Management to ensure change control documentation are completed in a manner in compliance with FDA and EMA
    • Set up a calibration program and review equipment calibrations.
    • Implement SOP and templates to support validation and qualification programs.
    • Set up periodic review program
    • Prepare and present KPI as required


Qualifications
    • Minimum 10+ years of a pharmaceutical/biotechnology experience
    • BS/MS degree in Biology, Chemical Engineering, or Chemistry
    • Experience in cGMP clinical and/or commercial is required
    • Validation and qualification experience of a new GMP facility start up is preferred.
    • Proficiency with MS office (Excel, Word, PowerPoint, Visio)
    • Experience with EDMS systems is preferred.
    • Great understanding of regulatory requirements including ICH and GAMP5


Core Competencies
    • Strong work ethic (self-motivated)
    • Excellent collaboration with cross functional teams
    • Self-reliant, a good problem solver, and result oriented
    • Desire to work with a diverse team in a fast-paced environment under challenging timelines
    • Excellent verbal and written communication skills
    • Detail orientation


Salary and Benefits
    • Base pay and stock options to be determined based on application qualifications with the aim of being competitive with similar roles in the area
    • Significant growth opportunity as the company expands




Senti Bio is a leading gene circuit company designing gene circuits to create a new generation of "smarter medicines" and enhance the therapeutic effectiveness of cell and gene therapies against a broad range of diseases that are unaddressed by current standards of care. We are proud to count Leaps by Bayer, NEA, 8VC, Matrix Partners China, Mirae Asset Capital, Amgen Ventures, Intel Capital, Ridgeback Capital, Lux Capital, KB Investment, Pear VC, Smilegate Investment, Menlo Ventures, LifeSci Venture Partners, Alexandria Venture Investments, Allen & Company, LifeForce Capital, Omega Funds, Nest.Bio, Gaingels, Noveus Capital, and Goodman Capital among our investors. Senti Bio is based in South San Francisco, CA, USA.