Site Head of Quality/ Senior Director

Rose BioSolutions

Rockville
Permanent
On-site
$211,000 - $236,000/year
Viral Vector Quality ManagementClinical-to-Commercial Licensure ReadinessGlobal Regulatory Strategy (FDA/EMA)

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.