Senior Director / Executive Director, Quality Assurance
Company: THIRD ROCK VENTURES, LLC
Location: Redwood City
Posted on: May 15, 2022
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Job Description:
Senior Director / Executive Director, Quality Assurance at
Revolution Medicines Revolution Medicines is a clinical-stage
precision oncology company focused on developing novel targeted
therapies to inhibit high-value frontier targets in RAS-addicted
cancers. The company's R&D pipeline comprises RAS(ON)
Inhibitors designed to suppress diverse oncogenic variants of RAS
proteins, and RAS Companion Inhibitors for use in combination
treatment strategies. As a new member of the Revolution Medicines
team, you will join other outstanding professionals in a tireless
commitment to patients with cancers harboring mutations in the RAS
signaling pathway. Playing a critical role within the RevMed
Development organization, the Head of Quality Assurance will lead
the development, implementation and oversight of the company's
quality systems and ensure an appropriate level of effectiveness
and compliance with GxP and other relevant ICH, US and EU
regulations. The position will also be responsible for managing
quality operation, training and infrastructure, in addition to
performing internal and external audits. The candidate will provide
strong leadership and expertise in setting and maintaining
compliance standards. Responsibilities: Assure high standards of
Quality in all aspects of Research and Development, including GMP,
GCP and GLP compliance. Foster a culture of continuous improvement
in all aspects of GxP Quality, including the development and
administration of policies and practices that address quality
issues throughout the organization. Develop and maintain GCP, GLP
related quality system SOPs, and maintain GMP related quality
system SOPs, in compliance with all applicable regulatory
requirements and as appropriate for the company's current needs.
Provide GxP QA oversight of external vendors' quality programs,
including negotiating and maintenance of quality agreements and
vendor compliance. Ensure the clinical trials,
preclinical/nonclinical studies and manufacturing campaigns are
performed in accordance with applicable protocols and in compliance
with applicable regulatory requirements. Evaluate quality
events/incidents/issues and perform risk analysis, identify
remediation actions and communicate to management or other
stakeholders, as appropriate. Manage/conduct external quality
audits of clinical sites, clinical and preclinical vendors, CMOs
and other manufacturing vendors. Manage/conduct internal audits to
ensure compliance with policies, procedures, GxP requirements and
guidelines. Design and oversee the company's training program.
Provide expert GxP advice to internal stakeholders. Required
Experience, Skills and Education: Bachelor's degree in a relevant
scientific or technical discipline. An advanced degree and directly
relevant professional certification are desirable. Minimum 15 years
of relevant experience in the pharmaceutical industry with at least
ten years at the management level with responsibility for
manufacturing/GMP and/or GCP QA/QC. Proven track record of
leadership and people management is required for this
Director-level role. Strong knowledge of GCP, ICH, FDA, EMA, as
well as other relevant US and international regulatory
requirements. Broad understanding and experience in GxP and QA
principles and industry standards are desirable. Experience with
small molecule development programs from early-stage to late
clinical stage is preferred. Ability to build consensus among
colleagues with an appropriate level of flexibility, while
maintaining a focus on results and goal attainment. Ability to
constructively relay analytical and technical insight/expertise.
Strong interpersonal, teamwork, and organizational skills, as well
as effective oral and written communication skills. Travel will be
required. Revolution Medicines currently requires that all
personnel and visitors to its offices be fully vaccinated against
COVID-19. This role will require that the employee meet with
company employees and work from the company's offices. Given that
these essential functions of the role must be performed on-site,
this position requires full COVID-19 vaccination, subject to
applicable law. Revolution Medicines is an equal opportunity
employer and prohibits unlawful discrimination based on race,
color, religion, gender, sexual orientation, gender
identity/expression, national origin/ancestry, age, disability,
marital status, medical condition and veteran status. 29 Newbury
Street
3rd Floor
Boston, MA 02116
P (617) 585-2000
Keywords: THIRD ROCK VENTURES, LLC, Redwood City , Senior Director / Executive Director, Quality Assurance, Executive , Redwood City, California
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