Associate Director, QA Validation Engineer

Location
South San Francisco, California
Posted
Sep 29, 2021
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
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 commissioning, calibration, validation, and qualification activities (e.g., facility, cleaning, utility, equipment, software) including but not limited to review and approval of protocol, summary reports, SIA, URS, FRS, Traceability Matrix, and all other related documents.
  • Act as QA SME to support validation/qualification projects
  • Manage validation and qualification deviation investigations.
  • Implement Change Control Management to ensure change control documentation are completed in a manner in compliance with FDA and EMA
  • Set up calibration program and provide QA review and approval of equipment calibrations.
  • Manage technical transfers within the sites and/or from pre-clinical to GMP facility.
  • Implement VMP, SOP and templates to support validation and qualification program life cycle.
  • Implement and manage risk management program
  • Implement and manage periodic review program
  • Prepare and present KPI to executive management team

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 new GMP facility start up is highly desired
  • Proficiency with MS office (Excel, Word, PowerPoint, Visio)
  • Previous experience with EDMS and EQMS (e.g., Veeva, TrackWise) systems is required.
  • 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
  • Empathetic, supportive and collaborative colleagues and work environment


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.