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Director, Quality Assurance

Company: Amazon Workforce Staffing
Location: Woonsocket
Posted on: September 17, 2020

Job Description:

Company: GREELEY CO

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Director/Senior Director, Quality Assurance

About Stoke:

Stoke Therapeutics is a biotech company using RNA science todeliver a new generation of genetic medicines. By using aproprietary platform that restores protein levels, we take aim atsevere genetic diseases that have inadequate or no treatmentoptions. Our first area of focus is Dravet syndrome, a severe andprogressive form of epilepsy that strikes children within the firstyear or two of life. For more information, visitwww.stoketherapeutics.com and follow Stoke on Twitter(@StokeTx).

Position Purpose:

Stoke is seeking an enthusiastic and highly motivatedDirector/Senior Director, Quality Assurance to join the Qualitygroup. The successful candidate will be responsible for: helping todefine, communicate and implement the company’s quality strategyand vision. This role will develop strong relationships,collaborate, and interact with various departments and levels ofmanagement at Stoke Therapeutics to accomplish the company’sobjectives. This individual will also collaborate and developstrong relationships and partner with external collaborators toensure the appropriate processes, systems, and activities are inplace to protect the rights, safety, and welfare of studysubjects.

Key Responsibilities Include:

Provide strategic and proactive QA leadership in alignment withGlobal Head of Regulatory Affairs & QA

Responsible for the operational management of local QualityManagement System (QMS) covering GCP and/or GMP activities of abiotech company in alignment with corporate QMS.

Manage and oversee the local QMS e.g. SOP system

Training system

Audit system covering GCP & GMP audits

Batch disposition, recall, and field alert system

Provide guidance, interpretation, support, training, and keyinput to relevant stakeholders in the company for consultation andinterpretation of regulations, guidelines, corporate standards, andSOPs

Development of employees (as the role grows)

Provide input to budget planning and oversee budget for yourarea of responsibility

Ensure inspection readiness

Requirements

Required Experience:

Bachelor's Degree or above in a Science/Engineering or relatedfield.

10 year’s experience preferred in the pharmaceutical/biotechindustry and in QA, including direct experience in a GxPenvironment

At least 5 years of demonstrated leadership experience inleading QA professionals

Experience in performing audits of GMP and/or GCP areas highlydesirable

Experience in setting up quality system in GMP and/or GCParea

Detailed knowledge of cGMP and GCP regulations (such as 21CFRpart 210, 211, 312, 314 etc.) and guidelines (e.g. ICH GCP)

Independent self-starter is a must

Travel:

Approximately 10-20% of this position will require travel.

Location(s):

This position will primarily be located in Bedford, Mass orCambridge, Mass.

Benefits & Compensation:

Stoke Therapeutics offers comprehensive and competitive employeebenefits, including: medical, dental and vision insurance; life,long and short-term disability insurance; Paid Primary CaregiverLeave; a 401K program with company match, and an Employee StockPurchase Program (ESPP). Compensation will be highly competitivefor the industry and directly commensurate with experience.

Interested candidates should apply directly to the positionlisted on Stoke’s website:

Position Title: Director/Sr.Director, Quality Assurance

Company Name: Stoke Therapeutics

Job Function: Quality Assurance

Job Type: Full-Time

Job Duration: Indefinite

Min Education: BA/BS/Undergraduate

Min Experience: Over 10 Years

Required Travel: 10-25%

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Keywords: Amazon Workforce Staffing, Woonsocket , Director, Quality Assurance, Other , Woonsocket, Rhode Island

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