Site Head of Quality/ Senior Director at Aquila Talent Solutions

At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells, to the complete advanced therapy manufacturing continuum, from cellular starting materials, plasmid DNA, and viral vector production, through cell therapy manufacturing, all with industry-leading timelines. This is not a start-up; it is an established operation with a world-class team of experts. We have decades of expertise in delivering cellular starting materials and viral vector production and have been a trusted provider of plasmid DNA manufacturing since 1992. Rose BioSolutions is proud to offer the full continuum of capabilities as part of a single, comprehensive offering, as well as demonstrated commercial supply to both the US and EU, eliminating the supplier handoffs and knowledge gaps where programs stall.

Every process we design connects to the same mission: delivering industry-leading therapies for our clients and keeping patient needs at the center of everything we do. We apply our R.O.S.E standard to every program and every relationship: Reliable, Outcome driven, Scalable, and Excellent! If you are interested in joining Rose Bio and making a real impact on the health and well-being of people living in your community and across the globe, please click the link below to apply.

Site Head of Quality

Location: Rockville, MD
Reports To: Global Head of Quality
Department: Quality
Employment Type: Full-Time, Site Leadership Team

Position Summary

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.

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.

Core Values

Reliable: We deliver with integrity, precision, and consistency.
Outcome Driven: We focus on measurable results that create value for our clients and improve patient outcomes.
Scalable: We design systems, teams, and processes built for controlled growth and commercial success.
Excellent: We pursue the highest standards of technical, operational, and ethical performance.

Why Join Us

Join a private equity–backed, global CDMO specializing in viral vector manufacturing at the forefront of cell and gene therapy innovation. As the Site Head of Quality, you will shape the standards, systems, and culture that underpin operational excellence and regulatory confidence. You will lead a pivotal site positioned for significant expansion — transforming agile, development-phase operations into a world-class commercial-quality organization built on reliability, results, scalability, and excellence.

About Rose BioSolutions

Rose BioSolutions is a Cell and Gene Therapy CDMO and Cell Solutions business offering the industry's best manufacturing of advanced therapies and the starting materials they depend on, as well as human immune cells and stem cells for early-stage researchers. With over 500 employees within four facilities in the US and UK, we are engineered to deliver with partnership and expertise built into every aspect of what we do. We have onsite roles at facilities in Memphis, TN, Rockville, MD, Keele, UK, and Northridge, CA, as well as select remote work opportunities.

We're dedicated to offering competitive benefits that support and enhance your overall well-being. During the recruitment process, we will provide an overview of our benefits package.

Equal Employment Opportunity (U.S. Applicants only) Rose BioSolutions is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you are interested in applying to Rose BioSolutions and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to careers@rosebiosolutions.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications. For more information, please visit rosebiosolutions.com.