Principal Specialist/Manager, GxP Audits & Vendor Management

Company: Epizyme
Location: Cambridge
Posted on: January 12, 2022

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:
As the Principal Specialist/Manager, GxP Audits and Vendor Management, you will coordinate Epizyme's GxP Audit and Vendor Management programs. You will work with internal operational/QA partners and consultant auditors to ensure that audits are conducted in alignment with business expectations, cGxP standards, FDA, EMA, and other applicable regulatory requirements. You will partner with the to create a quality culture within Epizyme and help reach a sustained state of inspection readiness.

• Develop annual GxP vendor and internal audit schedules in collaboration with Quality Assurance and business operations leaders from CMC and Clinical.
• Support budget development based on audit schedules and expected contract auditor costs.
• Organize the sourcing of contract auditors to support audit activities.
• Coordinate the GxP audits performed by contract auditors or other internal auditors for GCP, GLP, GVP and GMP audits to maximize the value of each audit.
• Track closure of audit findings.
• Maintain Approved Vendor List.
• Support audit completion (as needed) as an audit team member.
• Participate in applicable process improvement initiatives.
• Contribute to GxP inspection readiness (e.g., BIMO, PAI, etc.) programs.
• Track Key Process Indicators (KPIs) for reporting of Quality Metrics.
• Support GxP training programs in connection with the company's quality objectives, strategies and processes; review SOPs, other controlled documents, and training courseware.
• Initiate QA deviations and CAPAs, perform investigations and root cause analysis. Education and Requirements:
  
  • BA/BS required, with a preference in the sciences or clinical scientific discipline.
  • Minimum of 3+ years of experience in biopharmaceutical industry, with the majority in the field quality assurance in the biopharmaceutical industry.
  • Previous GxP quality assurance auditing experience is a plus.
  • Knowledge and demonstrated experience in applicable GXP regulations (e.g., FDA, Good Manufacturing and Clinical Practices, ICH Guidelines, Global Drug Development Regulations and Guidance's and/or Computer System Validation).
  • Ability to work independently, set priorities, meet timelines, manage projects and motivate others.
  • Excels in collaborating with other departments to drive projects forward to meet quality objectives.
  • Strong verbal and written communication (including presentation) and customer management skills.
  • Experience with commercial products is strongly preferred.
  • Experience organizing Investigator site audits a plus
  • Ability to provide proof of current vaccination from COVID-19
    
    Epizyme, Inc. is a vibrant, entrepreneurial equal employment opportunity employer committed to fostering a diverse and dynamic workplace of multi-generational employees with varied life experiences and perspectives. Epizyme is taking a responsible approach to creating environments that allow us to do what we do best- discovery, development, and commercialization of oncology treatments through the utilization of Epigenetics. As part of our commitment to employee health and safety, COVID-19 vaccines are required for all U.S. salaried and hourly employees, as well as all newly hired employees. As part of our commitment to comply with all relevant regulations and guidances, if you are seeking a medical or religious exemption, you may request a reasonable accommodation at any point in the selection process. Supporting medical or religious documentation will be required where applicable. You may initiate that process by completing our Accommodations for Applicants form.

Keywords: Epizyme, Cambridge , Principal Specialist/Manager, GxP Audits & Vendor Management, Executive , Cambridge, Massachusetts