Senior Manager, Quality Assurance

Senior Manager Quality Assurance

Hybrid - Rockville, MD

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Senior Manager, Quality Assurance leads key elements of the Quality Management System (QMS) supporting a fastmoving, techdriven business unit. This role manages and carries out core QMS activities-including hosting client audits and regulatory inspections, managing quality incidents and CAPAs, and providing proactive quality guidance-ensuring that innovative, technologyenabled operations remain compliant with regulatory, industry, and GCP requirements while driving a culture of continuous improvement and operational excellence.

• Hosts client audits and regulatory inspections and ensures ongoing inspection readiness
• Manages quality incidents, deviations, and CAPAs from investigation through effectiveness verification
• Plans and maintains audit schedules and conducts vendor and internal audits
• Reviews and approves audit reports and quality records
• Provides expert quality and compliance guidance to teams
• Develops and maintains QA policies, procedures, and quality documentation
• Analyzes quality data to identify trends and drive continuous improvement
• Leads qualityfocused process improvement initiatives
• Prepares concise quality reports for leadership and delivers essential quality training
• Mentors and may supervise QA staff

• Bachelor's degree in Life Sciences or a related scientific field
• Ten (10) years experience working in a regulated environment (e.g., GCP, ISO), to include management experience
• Previous experience in quality and/or compliance related roles.
• CQA, CCRP, ISO certification (or equivalent) preferred
• Ability to prioritize critical tasks and provide a high level of responsiveness and timely service on a day-to-day basis as well as balance the unexpected needs of the company as they arise
• Demonstrated organizational skills, high attention to detail, and ability to multi-task
• Strong written and verbal communication as well as problem-solving skills
• Microsoft Office proficiency
• Intermediate knowledge and understanding of 21CFR Part 11/EU Annex 11, GAMP 5, and related industry standards preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

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The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

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