Vp/svp Quality Operations
4 weeks ago
**Bedford, MA**:
**About Us**
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 facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
On April 3, 2024, we announced closure of a significantly oversubscribed $160.5 million Series C financing with a top-tier syndicate of life science investors led by new investor, Wellington Management. Proceeds from the financing will advance Obsidian’s lead program in its ongoing trials. We’re focused on enrolling patients and reaching key clinical and regulatory milestones, as well as manufacturing scale-up ahead of pivotal trial readiness.
**Our Opportunity**
We’re seeking a visionary and hands-on leader for this newly created position. This position is responsible for oversight of all GXP operations inclusive of leading Clinical Quality, Quality Assurance, Quality Control, Quality Systems, Quality Assurance Validation, Quality Risk Management and Quality Compliance. The charter is to partner across the organization to define and drive a holistic Quality strategy and roadmap to enable success from clinical development through commercialization and cultivate a culture of quality while ensuring overall GxP compliance.
- or gene-therapy). Critical success factors include well-rounded GXP experience, success in developing and leading robust Quality operations, developing and motivating high performing teams, and overseeing an externalized GMP environment.
This role reports to our Chief Technical Officer (with a dotted line to the CEO) and is based in our Bedford MA location (hybrid).
**You Will**
- Partner across the organization to define and implement a clear quality vision and strategic plan from Phase I/II clinical to commercial to support company’s goals for the development, manufacture, and future global commercialization of autologous cell therapy products.
- Lead quality oversight for all GXP activities internally and externally ensuring systems and processes are in-place and in-use for compliance with global current good manufacturing practices (cGMP).
- Develop, maintain and administer an efficient and effective risk based and phase appropriate Quality Management System (QMS) in compliance with regulatory requirements and industry recognized best practices for cell and gene therapy clinical and commercial products.
- Ensure internal and external inspection readiness at all times and lead regulatory body inspections to positive outcomes. Engage in proactive relationships with FDA and other regulatory authorities.
- Establish key performance indicators in alignment with company and operational goals; maintain and report applicable department and Quality System metrics and take action on adverse trends.
- Proactively identify, assess, and mitigate quality, operational, and organization risks; escalate key risks and issues.
- Drive a continuous improvement and operational excellence culture of the QMS from all levels of the organization thru self-detecting and self-correcting process and systems and instilling strong ownership and accountability at all levels.
- Recruit, develop, lead, coach and motivate a highly engaged, skilled, collaborative, and high performing Quality team. Cultivate a team culture of high standards, collaboration, empowerment, innovation, inclusion, trust, and continuous learning.
- Ensure all vendor contracts, including Quality agreements, are effectively negotiated to meet the quality and regulatory requirements needs of Obsidian in a cost-efficient manner.
- Develop and manage quality organizations annual operating budgets; partner with management and Finance to analyze variances and implement adjustments.
**You Bring**
- Core _Qualifications_
- Bachelor’s degree preferably in the life sciences.
- 20+ years of biotech/pharma industry experience, including 10+ years in progressive Quality Leadership roles in dynamic small to medium sized companies.
- Significant experience building and growing quality capabilities for an externalized GXP environment and supporting clinical through commercial operations.
- Strategic, pragmatic, phase-appropriate, risk-based approach to Quality Assurance based on experience in clinical stage to commercial stage biotech.
- Successful oversight of internal and external manufacturing with multiple and diverse CDMOs.
- A leadership approach that inspires confidence, credibility, and trust internally and externally; you’re adept at building buy-in to strategies and agreements with senior leadership and partners.
- Communicates effectively across all levels within the organization. Understands different point
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