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Manager or Senior Manager, Supplier Quality Management

Senti Biosciences

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Quality Assurance

South San Francisco, CA, USA

Posted on Tuesday, March 14, 2023

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.

Summary:

Senti Bio is currently recruiting for a Manager or Senior Manager, Supplier Quality Management, reporting to the Sr. Director, Quality. The ideal candidate has early phase biotech experience as well as experience establishing and maintaining risk-based Supplier Quality programs in an early phase clinical environment. This individual contributor role is responsible for management of the supplier quality lifecycle, including selection, qualification and monitoring of GxP and pre-GxP suppliers such as service providers, raw material suppliers, Contract Manufacturing Organizations, and Contract Test Laboratories. This position will also manage Senti’s phase-appropriate internal audit program.

Location: Hybrid, Alameda or South San Francisco, CA, USA

Responsibilities:

Establish and maintain a risk-based Supplier Quality Management program, ensuring alignment with FDA and EMA regulatory expectations.
Collaborate with internal stakeholders including Supply Chain, Legal, Pre-Clinical, Clinical, MSAT, QC, Manufacturing, and others to align strategy and define actions needed to ensure supplier quality.
Establish Quality Assurance Agreements (QAAs) with critical suppliers.
Monitor supplier performance including change and deviation notifications, and manage supplier history files.
Establish and maintaining systems for GxP document archive/retention.
Establish and maintain strong working relationships with suppliers, proactively initiating and supporting continuous improvement initiatives.
Report quality system and supplier performance metrics to Quality Management Review.
Implement and lead the internal audit program to support inspection readiness.
Implement processes to monitor observations, responses, and CAPA actions.

Qualifications:

Minimum 8+ years of relevant experience including pharmaceutical/biotechnology industry experience and supplier quality management experience.
BS/MS degree in Biology, Chemical Engineering, Chemistry or a related field.
Excellent understanding of regulatory requirements with focus on FDA and EMA
Strong collaboration with internal and external cross functional teams
Excellent verbal and written communication skills

Salary and Benefits:

Compensation for this role includes base salary, annual target bonus and equity
The base salary range for this role is $155,000 - $169,000. Starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parity
Significant growth opportunity as the company expands
Empathetic, supportive and collaborative colleagues and work environments

Senti Bio is a publicly traded (Nasdaq: SNTI) gene circuit company headquartered in South San Francisco. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases using novel and unprecedented approaches.

We are committed to an inclusive and diverse Senti Bio. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse Senti Team. We welcome people of different backgrounds, experiences, abilities and perspectives and are an equal opportunity employer.