Building expert teams to advance science.

About the Role 

At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, and we apply our R.O.S.E standard to every program and relationship: Reliable, Outcome driven, Scalable, and Excellent!

The Site Head of Quality is a senior leader responsible for all aspects of Quality Assurance (QA) and Quality Control (QC) at a viral vector manufacturing site supporting cell and gene therapy clients. This role defines and executes the site quality vision — ensuring regulatory compliance, client satisfaction, and commercial readiness as the organization scales rapidly under private equity ownership.

This leader will ensure the highest standards of quality and compliance are embedded into daily operations while driving strategic alignment with global systems and business objectives. The position requires a balance of scientific depth, strategic vision, and operational discipline, creating a best-in-class quality organization that supports the company’s rapid growth trajectory and future commercialization goals.

Our core values — Reliable, Outcome Driven, Scalable, Excellent — are the foundation for how we operate and deliver value to our clients and, ultimately, to patients.

Why Rose BioSolutions 

At Rose, you are not just another layer in a large organization—you are a key contributor in a nimble, high-impact team. We offer:

• Direct exposure to diverse and complex client projects across multiple modalities.

• A collaborative, low-bureaucracy environment where ideas are heard and acted upon.

• Opportunities to grow your technical expertise and take ownership of your work.

• Close interaction with leadership and clients, enabling real influence on project outcomes.

Key Responsibilities

Strategic Quality Leadership

• Serve as the site Quality authority and primary contact for all regulatory agencies (FDA, EMA, MHRA, etc.) for viral vector–related activities and inspections.

• Lead the design, implementation, and continuous improvement of the site’s Quality Management System (QMS) tailored to viral vector processes and phase-appropriate cGMP requirements.

• Oversee QA and QC operations supporting viral vector manufacturing across development and commercial programs, ensuring compliance with global regulatory expectations.

• Provide decisive quality oversight in product release, deviation and CAPA management, change control, and validation—ensuring timely and compliant decision-making.

• Authorize lot disposition decisions and act as the final escalation point for all quality matters at the site.

Regulatory and Client Engagement

• Lead readiness for client audits and  regulatory inspections including pre-licensing inspections (PLIs)

• Serve as the senior Quality contact for client programs, overseeing Quality Technical Agreements (QTAs), ensuring clear communication of quality standards, and supporting client success across development and commercial phases.

• Collaborate with Global Quality and Regulatory teams to ensure consistency in interpretation and application of quality policies across the CDMO network.

• Support preparation and review of regulatory submissions and client documentation involving vector manufacturing, validation, and control strategy.

Operational Excellence and Network Integration

• Partner cross-functionally with Manufacturing, MS&T, Supply Chain, and Business Development to align quality oversight with operational execution, ensuring manufacturing reliability and client satisfaction.

• Lead and sponsor site quality improvement initiatives, digital system implementation, and data integrity enhancements that strengthen overall compliance posture.

• Contribute to the global Quality leadership network, facilitating the sharing of best practices and harmonization of standards across sites.

Leadership and Culture

• Build and inspire a best-in-class Quality organization that thrives in a fast-paced, entrepreneurial, and science-driven environment.

• Develop and mentor technical and leadership talent within the Quality function, fostering empowerment and accountability.

• Advance a culture of proactive compliance, collaboration, and continuous improvement that supports employee development and client confidence.

• Champion our guiding values — Reliable, Outcome Driven, Scalable, Excellent — through consistent actions and leadership integrity.

Qualifications and Experience

• Bachelor’s degree in Life Sciences, Engineering, or related discipline required; advanced degree (MS, PhD, MBA) preferred.

• Minimum 12 years of progressive Quality leadership experience in biologics or advanced therapies, preferred viral vector (AAV, lentivirus, or adenovirus) manufacturing and Quality experience.

• Proven track record leading a site or major function through clinical-to-commercial transition and licensure readiness.

• Deep understanding of global regulatory expectations (FDA, EMA, MHRA, ICH) for viral vector–based products, including contamination control and biosafety requirements.

• Demonstrated experience operating within a CDMO environment, balancing client service and compliance with operational and financial performance.

• Strong business acumen and ability to manage within a private equity–backed, growth-oriented structure.

• Excellent communication, negotiation, and leadership skills with the ability to influence across technical and executive teams.

• Experienced in the use of electronic QMS, LIMS, and modern analytical data systems; Lean Six Sigma certification preferred.

Why Join Us?

• Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.

• Expertise: Work alongside a world-class team of scientists and operational leaders in a "no-ego" environment.

• Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization.

Perks & Benefits

• Competitive base salary with performance-based bonus opportunities.

• Comprehensive health, dental, and vision insurance.

• 401(k) with company contribution.

• Generous PTO and professional development support.

Rose BioSolutions is an equal opportunity employer committed to a diverse and inclusive workforce.