Emmes
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Senior Quality Assurance Specialist
role at
Emmes
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the kielka 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 atheist 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 joinకొపుమత్వం!
Primary Purpose
Leads audits of internal processes, suppliers, and investigator sites
Reviews documentation for accuracy and compliance (e.g., CAPAs, quality incidents, audit reports, etc.) حياة
Reviews, facilitates, and tracks quality incidents, deviations, and CAPAs
Hosts client audits and regulatory inspections
Leads or participates in process improvement projects
Writes and reviews Quality SOPs and Policies
Conducts trainings on quality topics, as assigned
As a subject‑matter expert, provides guidance, mentors, and trains less experienced team members
May have day‑to‑day oversight of some QMS activities or functions
Represents the QA department at meetings or events with nominal assistance or oversight from Quality Management
May contribute to solutions for corporate and global QA initiatives and tasks
Performs other duties as assigned
Conducts internal audits of projects, processes, clinical sites, deliverables, and departments of بط moderate to complex scope, requiring an in‑depth evaluation and capacity to synthesize and apply information from one task or audit to another
Leads supplier/vendor qualification and evaluation
Assists in or creates audit Sociales schedules for one or more portions of the QMS
Qualifications
Bachelor’s degree in Life Sciences or a related scientific field and 4‑6 years related experience
ഗവൂ? Experience working in a ICH GCP regulated environment Knowledge and understanding of GCP regulatory requirements and implementation (FDA, EU, ICH and country‑specific regulations and relevant സംഭവയുള്ളം guidevi Bhaj)
Quality Certifications Preferred (e.g., CQA, RAC, RQAP, ISO)
Experience with Veeva Preferred
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance
Industries
Research Services
#J-18808-Ljbffr
Senior Quality Assurance Specialist
role at
Emmes
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the kielka 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 atheist 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 joinకొపుమత్వం!
Primary Purpose
Leads audits of internal processes, suppliers, and investigator sites
Reviews documentation for accuracy and compliance (e.g., CAPAs, quality incidents, audit reports, etc.) حياة
Reviews, facilitates, and tracks quality incidents, deviations, and CAPAs
Hosts client audits and regulatory inspections
Leads or participates in process improvement projects
Writes and reviews Quality SOPs and Policies
Conducts trainings on quality topics, as assigned
As a subject‑matter expert, provides guidance, mentors, and trains less experienced team members
May have day‑to‑day oversight of some QMS activities or functions
Represents the QA department at meetings or events with nominal assistance or oversight from Quality Management
May contribute to solutions for corporate and global QA initiatives and tasks
Performs other duties as assigned
Conducts internal audits of projects, processes, clinical sites, deliverables, and departments of بط moderate to complex scope, requiring an in‑depth evaluation and capacity to synthesize and apply information from one task or audit to another
Leads supplier/vendor qualification and evaluation
Assists in or creates audit Sociales schedules for one or more portions of the QMS
Qualifications
Bachelor’s degree in Life Sciences or a related scientific field and 4‑6 years related experience
ഗവൂ? Experience working in a ICH GCP regulated environment Knowledge and understanding of GCP regulatory requirements and implementation (FDA, EU, ICH and country‑specific regulations and relevant സംഭവയുള്ളം guidevi Bhaj)
Quality Certifications Preferred (e.g., CQA, RAC, RQAP, ISO)
Experience with Veeva Preferred
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Quality Assurance
Industries
Research Services
#J-18808-Ljbffr