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Company

Original Job Post

Senti Biosciences · 3 days ago

Associate Director, Quality Assurance

South San Francisco, CA

Full-time

Onsite

Director

$168K/yr - $195K/yr

10+ years exp

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BiotechnologyHealth Care

H1B Sponsorship

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Responsibilities

Lead lot disposition activities

Perform QA review of manufacturing batch records and batch release packages, IND-related documents, as well as SOPs, protocols, and technical reports

Leverage a risk-based approach to compliance including generation, coordination and maintenance of risk assessments

Establish and maintain Quality Assurance Agreements (QAgs) with critical suppliers

Generate and maintain Quality Assurance procedures and programs, ensuring alignment with FDA and EMA regulatory expectations

Collaborate effectively and maintain strong working relationships with a wide variety of stakeholders including Supply Chain, Regulatory Affairs, Legal, Pre-Clinical, Clinical, Tech Ops, Project Management and others to provide QA oversight, quality partnership, and to build Senti Quality Culture and a compliance mindset

Serve as a quality partner for external manufacturing providers, including leading QA to QA meetings, leading or overseeing audit activities, and CAPA/deviation/change management

Establish and maintain systems for GxP document archive/retention

Proactively lead and support continuous improvement initiatives

Report quality system and supplier performance metrics to Quality Management Review

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Quality AssuranceGxP RequirementsFDA RegulationsEMA RegulationsPharmaceutical Industry KnowledgeBiotechnology Industry Knowledge CommunicationClinical Quality AssuranceSupplier Quality ManagementExternal Manufacturing OversightCell Therapy

Required

Minimum 10+ years of relevant experience including pharmaceutical/biotechnology industry and Quality Assurance experience

BS/MS degree in Biology, Chemical Engineering, Chemistry or a related field

Excellent understanding of GxP requirements with focus on FDA and EMA

Excellent verbal and written communication skills

Preferred

Experience in the areas of Clinical Quality Assurance, Supplier Quality Management, External Manufacturing Oversight, or Cell Therapy

Benefits

Significant growth opportunity as the company expands

Empathetic, supportive and collaborative colleagues and work environments

Company

Senti Biosciences

Senti Biosciences is a developer of a programmable biology platform for cancer therapies.

Founded in 2016

South San Francisco, California, USA

51-200 employees

https://www.sentibio.com/

H1B Sponsorship

Senti Biosciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (6)

2022 (2)

2021 (1)

2020 (2)