Quality System Specialist
Company: Epizyme
Location: Cambridge
Posted on: February 17, 2021
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Job Description:
Epizyme, Inc. is a fully integrated, commercial-stage
biopharmaceutical company committed to its mission of rewriting
treatment for cancer and other serious diseases through novel
epigenetic medicines. In addition to an active research and
discovery pipeline, Epizyme has one U.S. FDA approved product,
TAZVERIK-- (tazemetostat), for the treatment of adults and
pediatric patients aged 16 years and older with metastatic or
locally advanced epithelioid sarcoma (ES) who are not eligible for
complete resection; adult patients with relapsed or refractory
follicular lymphoma whose tumors are positive for an EZH2 mutation
as detected by an FDA-approved test and who have received at least
2 prior systemic therapies; and adult patients with relapsed or
refractory follicular lymphoma who have no satisfactory alternative
treatment options. These indications are approved under accelerated
approval based on overall response rate and duration of response.
Continued approval for these indications may be contingent upon
verification and description of clinical benefit in a confirmatory
trial(s). The company is also exploring the treatment potential of
tazemetostat in investigational clinical trials in other solid
tumors and hematological malignancies, as a monotherapy and
combination therapy in both relapsed and front-line disease
settings. By focusing on the genetic drivers of disease, Epizyme
seeks to match medicines with the patients who need them. For more
information, visit www.epizyme.com.Epizyme has assembled a
world-class team with a passion for scientific innovation and a
commitment to developing novel epigenetic therapies.--Join a
dynamic, diverse and fun work environment consistent with Epizyme's
cultural attributes for success: camaraderie, collaboration,
disciplined, innovative, openness, patient-focused and resilient.
Key Responsibilities: The Principal Specialist, Quality Systems
will be responsible for providing Quality leadership and support to
all GxP departments in day-to-day operations relating to IT System
Development Lifecycle (SDLC) and Quality Management Systems (e.g.,
CAPA, Deviations, Change Control, Documentation, Training). The
individual will focus on ensuring consistent policy administration,
implement key improvement initiatives and solve compliance issues
related to Quality Systems.Responsibilities:-- Oversee IT GxP
computer system assessments, validation, change control, process
improvements and compliance governance at all applicable points of
the System Development Lifecycle (SDLC).-- Oversee management and
administration of Quality Management Systems related deliverables
(deviations, CAPAs, Change Controls, etc.) to ensure compliance to
Epizyme SOPs.-- Conduct quality investigations, root cause
analysis, identification and implementation of
corrective/preventive actions for Quality Assurance.-- Support the
management of an electronic quality management system in compliance
with applicable regulations (e.g. 21 CFR Parts 11, 210 and 211, ICH
Q9, E6 R2, etc.).-- Represent Quality Assurance on all assigned IT
projects in support of SDLC activities.-- Approve SDLC deliverables
and activities to ensure that procedures and methodologies are
followed and that appropriate and complete documentation is
captured and reported to support SDLC activities for assigned IT
systems, including associated change requests.-- Assist with
corporate and third-party inspection readiness activities.--
Provide support and contribute to other Quality Assurance
activities as necessary.-- Author Quality System SOPs and policies
in alignment with applicable regulations.-- Promote recognition of
company Quality Management System (QMS) and quality programs among
departments and stakeholders.-- Develop and implement training
programs in connection with the company's quality objectives,
strategies and processes.-- Support and participate in routine
audits of internal departments/functions and third parties (CMOs)
to ensure quality systems practices are being followed.-- Track
Quality System metrics and periodic review data for Quality Council
and Quality Management Review.-- Propose quality improvements to
Quality Systems to maintain compliance and improve efficiency
utilizing risk-based methodologies.Education and Requirements: --
Bachelor and/or Masters in a Science, Engineering or a related
discipline is required-- 5+ years of quality assurance experience
in a pharmaceuticals or biotechnology industry.-- Advanced
knowledge and understanding of GxP regulatory requirements and
implementation (FDA, EU, ICH & country specific regulations and
other relevant guidance governing GxP activities)-- Knowledge of IT
Controls methodologies, including GAMP5, the computerized system
development life cycle, and software quality assurance in a
regulated environment-- Advanced knowledge and understanding of GxP
regulatory requirements and implementation (FDA, EU, ICH & country
specific regulations and other relevant guidance governing GxP
activities)-- Solid understanding of GxP guidance, including 21 CFR
Part 11, Annex 11 and Data Integrity.-- Strong communication
skills, both verbal and written as well as capable of presenting
the right level of information to senior management.-- Ability to
work both independently and with teams at various levels in the
organization.-- Ability to work in a very dynamic environment with
a clear sense of urgency.-- Ability to manage multiple projects in
a dynamic environment and ability to meet fast-track timelines--
Excellent organizational skills and attention to detail and
accuracy.-- Experience writing and reviewing SOPs which support GxP
processes and procedures-- Experience supporting health authority
inspections is preferred.-- Experience with Veeva Systems
(QualityDocs, eTMF, Submissions), UL ComplianceWire LMS, Trackwise
Digital QMS is preferred.Epizyme, Inc. is a vibrant,
entrepreneurial EEO employer committed to a diverse and dynamic
workplace.
Keywords: Epizyme, Cambridge , Quality System Specialist, Other , Cambridge, Massachusetts
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