Associate Director, Clinical Quality Assurance

Quality Assurance


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:

  • Supports Clinical QA Function
    • Provides input to clinical functions to ensure that clinical trial activities sponsored by Epizyme are conducted by CROs in compliance with GCP regulations and internal requirements
    • Implement risk-based investigator site management program and oversee the conduct or management of relevant site, vendor, and/or process audits including, but not limited to: Clinical Study Reports, Trial Master Files, Informed Consent Forms, Investigator’s Brochures, and Safety Reports
    • Works with internal customers to execute Quality Plans for clinical studies
    • Collaborates with global GxP Vendor Management function in the risk-based oversight of clinical vendors
    • Assists in resolving compliance issues at clinical sites, clinical vendors, laboratories and other vendors by providing an assessment of the impact of any deficiencies
    • Conducts vendor and investigator site audits
    • Implement CAPAs to address critical clinical QA issues
    • Acts as Clinical QA Study lead
    • Escalates systemic problems and appropriate recommendations/solutions to management for immediate and long-term resolution
    • Collaborates with internal customers to ensure regulatory filing documents are audited independently (NDA, MAA, etc.)
    • Participates in company preparations for regulatory inspections as the Clinical QA Study Lead
    • Reviews contracts with clinical vendors and partners to ensure compliance responsibilities are included
  • Supports the implementation and maintenance of QA systems and SOPs for GCP compliance including training
  • Interact with interdepartmental teams, clinical CRO’s, contract labs, and regulatory inspectors
  • Acts as an expert GCP consultant to groups within Epizyme organization
  • Tracks Key Process Indicators (KPIs) for reporting of Quality Metrics
  • Promote recognition of company clinical quality programs among departments and stakeholders
  • Manages Clinical QA consultants on complex projects
  • Maintains relevant knowledge of both local and international GCP requirements and development as they impact Epizyme standards
  • Other assignments as directed by QA management

 

Education and Requirements: 

  • BA/BS required, with a preference in the sciences, nursing or clinical scientific discipline
  • Minimum of 7+ years of experience in pharmaceutical drug development, with the majority in the field of clinical QA (GCP) in the biopharmaceutical industry 
  • Expertise in GCP regulations and guidance for FDA and international agencies including ICH
  • Demonstrated experience with QA in the areas of GVP and GLP is a plus
  • Desire to work “hands on” with minimal supervision, setting priorities, meeting timelines, and managing projects
  • Superb communication skills and the ability to shape, frame, and present to diverse internal and external audiences are requisite
  • Periodic travel on assignment to investigator sites and CROs (approximately 10-20 % of time)
  • Experience with Microsoft based applications and ability to learn internal computer systems 

 

Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.