Senior Manager Quality Assurance
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.
Responsibilities
- 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
Qualifications
- 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.
- CQA, CCRP, ISO certification (or equivalent) preferred.
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