Principal Specialist, Quality Systems
Company: Epizyme
Location: Somerville
Posted on: January 14, 2021
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Job Description:
DescriptionEpizyme, 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 .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 required5 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 environmentAdvanced 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
timelinesExcellent organizational skills and attention to detail
and accuracy.Experience writing and reviewing SOPs which support
GxP processes and proceduresExperience 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, Somerville , Principal Specialist, Quality Systems, Other , Somerville, Massachusetts
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