Principal Specialist, Quality Systems

Quality Assurance Cambridge, Massachusetts


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.