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We got a new job details in Aurion Biotech & they are Hiring Candidates for Manager, Quality Systems/Document Control
Company Name : Aurion Biotech
Company Location : Seattle, WA 98102
Job Position : Manager, Quality Systems/Document Control
Job Category : Jobs in Washington
Job Description :
JOB TITLE: Manager, Quality Systems/Document Control
ABOUT THE POSITION
This is a newly created role at Aurion Biotech. It is a unique and exciting opportunity to join a growing team of passionate professionals at the forefront of Cell Therapy and cornea care innovation. As Manager of Quality Systems, you will play a critical role in accomplishing this mission and in staging Aurion Biotech novel Cell Therapy treatment for successful launch in the United States.
The primary purpose of the Manager Quality Systems is to be responsible for supporting the development of early phase clinical quality system activities. This highly motivated member of the Quality Unit will help establish and maintain the quality management system (QMS) and drive document and change control processes within the electronic document management system (EDMS), while serving as the system owner. Additional responsibilities include supporting internal and external audits, deviation/CAPA management, all while promoting a culture of compliance throughout the organization through continuous improvement initiatives.
Work with Quality Head to define and implement the Quality Management System (QMS)
Write, review and revise Standard Operating Procedures (SOPs)
Review and control documents in accordance with document control procedures.
Oversee document templates and change control processes
Managing QMS events such as deviations, CAPAs, and change controls related to systems
Owns system administrative activities for the QMS
Addresses any user-related issues and provides end user support in the QMS
Assists in user provisioning of the quality management system
Partner with functional leaders to define system training plans and ensure timely completion of all training assignments
Support internal and external audits
Other duties as assigned.
QUALIFICATIONS AND EDUCATION
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA/BS in Science
6 to 9 years’ experience in Quality Systems in GMP environment
REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES
Familiarity with FDA, ICH, and EU Regulations and Guidelines
Experience with ensuring alignment with relevant GxP guidance and regulations
Involvement in continuous improvement initiatives
Familiarity with Contract Manufacturing Organizations (CMO) desirable
Proficient use of MS Office products, as well as ownership of GMP electronic applications (e.g., Veeva)
Ability to meet deadlines, adapt to rapid changes, and work in a fast-paced team environment
Ability to work effectively both independently and with other team members.
Interpersonal skills including the ability to influence without authority and negotiate and resolve challenges with poise, tact, and diplomacy
ABOUT AURION BIOTECH
Based in Seattle and Boston, Aurion Biotech is a clinical-stage biotech company. Our mission is to restore vision to millions of patients with life-changing regenerative therapies. Our first candidate is for the treatment of corneal endothelial disease, and one of the first clinically validated cell therapies in corneal care. In Japan, we’ve completed early research, dose ranging and confirmatory clinical studies; and we are preparing a submission to the PMDA for market approval. In the US, we are preparing an IND submission to the FDA. Based on results to date, we believe that our cell therapy has the potential to fundamentally transform the treatment of patients suffering from corneal endothelial dystrophies. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:
Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company.
Transformation: We embrace our challenges, our successes, and our failures.
We are curious, we take risks, and we collaborate.
Grit: We break down walls and strive to achieve the impossible. We are
persistent and resilient, and we deliver on our commitments.
Aurion Biotech has a lot to accomplish in the next few years and this role is key to our
The company is backed by leading ophthalmology investors, including Flying L
Partners, Visionary Ventures, KKR’s Falcon Vision Fund, and Petrichor.
The Aurion Biotech team is preparing for clinical trials in the U.S. To learn more,
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