Senior Manager, Quality Assurance

Found in: beBee jobs US - 1 week ago

New Bedford, Massachusetts, United States Obsidian Therapeutics Full time

Senior Manager, Quality Assurance (Cell Therapy)

Bedford, MA

About Us...

Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian's programs apply our cytoDRiVE platform technology to express regulated therapeutic proteins to enhance anti-tumor activity. We're currently investigating our lead program OBX-115 and enrolling patients in an ongoing clinical trial in advanced or metastatic melanoma.

We're proud of our diverse talented team and committed to cultivating an environment where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our research team is based in the heart of Cambridge, MA, and our Technical Development, Manufacturing & Quality team is based in our new facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.

Our Opportunity...

We're looking for a motivated, experienced, purpose driven Sr. Manager, Quality Assurance to plan, coordinate, and execute multiple complex projects to support corporate goals and compliance with all regulatory requirements. As a member of the Quality Assurance Team, you'll provide quality oversight including: CDMO production of Master and Working Cell Banks, Viral Vectors, and other critical materials used in clinical and GMP settings. As part of our Technical Development, Manufacturing, and Quality group you'll be a vital part of a highly collaborative team working to achieve Obsidian's vision by translating innovative science into medical breakthroughs for patients, starting with our lead program OBX-115.

This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.

You Will...

Provide QA support for manufacturing operations across all phases of development including CMC, analytical operations, and materials management.
Manage clinical batch disposition - review batch data including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition.
Manage archive of batch records and other disposition supporting documents in internal document/record repositories.
Generate performance metrics and trends, including site metrics for disposition.
Provide QA support of change controls, GMP investigations, associated CAPAs and Effectiveness Checks. Lead the investigation/CAPA triage meetings (as necessary) and collaborate with CDMO and internal partners to ensure quality systems are monitored and established metrics are met.
Identify risks and communicate any gaps for optimization of quality processes for area and equipment releases, material disposition, quality systems, etc.
Contribute to continuous improvements of department processes.
Support new product introduction.
Participate in IND preparedness, inspection readiness activities and provide support during regulatory site inspections.
Participate in Vendor/Supplier Qualification activities (i.e., Audits, site visits).
Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.
Provide compliance guidance to Obsidian project teams through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issues in a timely manner.
Development, review, and approval of QAAs.
Lead or participate in due diligence audits as well as scheduled supplier audits.
Conduct Regulatory Surveillance – watch trends and apply relevance to Obsidian processes, strategy, and best practice.

You Bring...

Core Qualifications
Bachelor's degree in biology, chemistry, engineering, life sciences or a related field, and 6+ years of relevant work experience (or M.S. and 4+ years of relevant work experience).

Understanding of both GCP and GMP requirements and best practices in drug development (strong preference for Cell Therapy).
Early and late clinical phase program experience.
Proficiency in providing QA support and oversight of GCP/GMP manufacturing operation including batch release, experience with CDMO manufacturing and testing.
Prior success working with CDMOs / CTLs quality to quality interactions.
Solid understanding of cGMP's and associated CMC regulatory considerations.
Successful experience leading event investigations, Root Cause Analysis (RCA), and CAPA.
Experience with both paper and electronic QMS systems. Contribution to the implementation of an electronic QMS system is a bonus.
Strong knowledge of GMP, SOPs, and quality system processes.
A team mindset and highly collaborative working style.
Ability to communicate effectively with scientific/technical colleagues, and effectively collaborate in a dynamic, cross-functional environment.
Outstanding communication skills. (verbal and written).
Ability to manage and deliver multiple projects in a fast-paced environment.
A systems thinker. Approaches problem solving and process design from with consideration of the overall system as well as its individual parts; considers interrelationships and patterns.
Demonstrates context-based sound judgement.

Bonus Qualifications
Experience in cell therapy highly preferred, biologics required.
Familiarity with FDA and EMA guidance documents relevant to gene and cell therapy analytical development and method validation.

Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.

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