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QA QMS Manager

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Company :
Gyroscope Therapeutics

Location :
King of Prussia, Pennsylvania

Expiry Date :
Sun, 04 Jul 2021 23:59:59 GMT

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Description :
This position will be responsible for managing, administering and monitoring Gyroscopes Quality Management Systems, specifically the Deviation, Audit, Change Control, Vendor Management and CAPA processes. Enhancement of existing procedures, and creation of new best practices will be a critical component of this role.

Essential Duties

* Leading and managing QAs day-to-day activities in support of Gyroscopes QMS with focus on the development, deployment, and management of the eQMS system (e.g., Deviations, CAPAs, Auditing, Change and Vendor Management, etc).
* Lead the QMS Program, specifically the deviation, CAPA, Audits, Training, Vendor Management & change control programs.
* Develop, improve, and administer the QMS Program.
* Serve as Quality Events Champion. Monitor Quality Events, Deviations and CAPAs. Track and trend these and monitor CAPA effectiveness.
* Provide subject matter expertise to improve the QMS.
* Develop and improve Quality department procedures.
* Generate and monitor quality metrics to ensure on-time record closure and identify corrective actions. Development, implement, and report applicable quality metrics and KPIs.
* Develop and present QMS metrics to management, as required.
* Create best practices for authoring technical investigations, root cause analysis tools, and corrective and preventive actions.
* Deliver training to the whole organization on QMS topics, as needed.
* Support internal and external audits related to the QMS. Managing the internal audit schedule. This includes generation of reports and CAPAs and following up on all action items to ensure their timely closure.
* Monitor and schedule vendor qualifications. Ensure these are conducted according to schedule.
* Support the change management program by helping to drive change controls to completion.

Requirements

* Extensive experience in a related Biopharmaceutical QMS role
* experience in one or more of GMP/GLP/GCP
* Experience in Biopharmaceutical QA and/or Quality System improvement roles is preferred.
* A BA or BS is preferred though long-time experience in QA may be acceptable
* Gene therapy experience is a plus
* Strong organizational skills and attention to detail
* Strong interpersonal and communication skills
* Computer skills and previous experience with eQMS
* Ability to provide subject matter expertise regarding QMS implementation and administration
* Past experience managing complex projects is required.
* Ability to identify areas of improvement and provide solutions. Excellent technical writing and problem-solving skills.
* Ability to work effectively at a fast-paced environment with cross functional departments. This role requires the incumbent to be able to quickly adapt to changing priorities.
* Ability to work independently and with minimal supervision is required.
* Some travel may be required (~20%)
* MS Office proficiency
* Project Management experience

Preferred Qualifications

* Experience with Gene Therapy / Cell Therapy products
* Previous experience with MasterControl
* Entrepreneurial and results driven

Benefits

Strong Basic Salary

401k Plan with Employer Match

Target Bonus based on Individual and Corporate Performance

Group Health Plan Medical coverage options including prescription coverage

All Medical coverage options also generally include wellness programs and telemedicine options (where permitted by state law)

Dental and vision coverage

Health Care Flexible Spending Account (FSA) Plan

About Gyroscope

Gyroscope Therapeutics is a clinical-stage retinal gene therapy company developing and delivering gene therapy beyond rare disease to treat a leading cause of blindness, dry AMD. Headquartered in London with locations in Philadelphia and San Francisco, our mission is to preserve sight and fight the devastating impact of blindness.

Gyroscope was founded in 2016 to explore the convergence of advancements made in the understanding of the complement systems impact on eye disease, the genetic basis of age-related macular degeneration (AMD) and gene therapy as a mode of sustained treatment delivery.

Gyroscope was created to bring the right people and resources together to fundamentally change the lives of patients suffering from retinal diseases. We know that our people, with their passion for patients, will drive to deliver on this promise. Our ultimate goal for our patients is Vision For Life and you will be a vital contributor.