Senior Manager/Associate Director, GXP Quality - Boston, MA, United States - Tango Therapeutics

Description

Senior Manager/Associate Director, GXP Quality

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

The Tango labs and offices are located at 201 Brookline Avenue, in the Fenway area of Boston, Massachusetts

Summary

Tango Therapeutics has an exciting new opportunity to join the team as Senior Manager/Associate Director, GXP Quality (GCP/GLP/GVP). Your primary responsibilities for this first in role position will be to ensure quality and compliance of Tango's development programs in accordance with applicable regulatory requirements (FDA/EMA, and current industry guidance) and internal procedures, as well as support the non-clinical team to ensure GLP studies are conducted in a compliant manner. In this role you will report to the Director, Quality & Compliance.

Your role:

• You will provide GCP/GLP/GVP QA oversight and support to cross functional stakeholders
• Support development of the annual GCP/GLP/GVP audit schedule
• Conduct and/or oversee GCP/GLP/GVP audits through closure as per the annual audit schedule, to include clinical investigator sites, CROs/vendors, process, system, study project, and document audits to assure compliance with global regulations, guidance, and internal procedures
• Track and effectively communicate deviation and audit trends to stakeholders
• Identify, investigate, escalate, track, and resolve quality issues originating internally and externally
• Liaise with QA counterpart at CRO/vendors
• Assist in preparing for and hosting regulatory inspections with cross functional stakeholders
• Conduct QA review of GCP protocols, ICFs, CSRs, and other clinical trial specific documents
• Conduct QA review of GLP reports and validation plans
• Additional duties and responsibilities as required

What you bring:

• Bachelor's Degree in a scientific discipline; advanced degree preferred
• 7-10 years in the pharmaceutical industry with 5 years in GCP QA
• Solid understanding of regulations and guidance for GCP, GLP, and GVP
• Experience with US and international clinical studies
• Able to travel domestically and internationally approximately 25% of the time
• Excellent verbal and written communication skills including experience reviewing clinical documents
• Good organizational skills and ability to work independently

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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Are you currently located in the Greater Boston area - OR - are you willing to relocate to the Greater Boston area in the near future? *
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Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Tango Therapeutics's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order

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