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 job oversees aspects of the Quality Management System (QMS) at Emmes and manages staff within the QA Department. Manager works with QA, company, and project leadership to ensure adherence to applicable regulations, industry standards, and project requirements.

• Manages one of multiple components of Emmes' Quality Management System

(e.g., internal auditing program, document control, CAPA program, etc.)

• Supervises QA Department staff
• Drafts and reviews QA policies and procedures
• Reviews and approves audit reports
• Creates audit schedules
• Analyzes quality data for improvements in the QMS
• Leads process improvement activities
• Leads client audits and regulatory inspections
• Prepares reports for QA management and internal leaders
• Provides corporate training and guidance as needed
• Other duties as assigned
• Manages the quality support for computer system validation activities for Emmes' proprietary, Veridix AI, and commercial off-the-shelf (COTS) software systems used in clinical trials.
• Leads review and audits of computer systems verification and validation processes to identify potential gaps and non-compliance.
• Ensures the review of validation documentation for computerized systems and applications.
• Manages deviations and CAPAs related to computerized systems

• Bachelor's degree in Life Sciences or a related scientific field
• Ten (10) years experience working in a regulated environment (e.g., GCP, GLP, GMP, ISO), to include management experience
• In addition, for computer system validation role: Advanced knowledge and understanding of 21CFR Part 11/EU Annex 11, GAMP 5, and related industry standards required with familiarity with security regulations such as NIST SP 800-53 and FISMA preferred.
• 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

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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