Principal Specialist/Manager, GxP Audits & Vendor Management
Posted on: January 12, 2022
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.
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
- 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
- Participate in applicable process improvement initiatives.
- Contribute to GxP inspection readiness (e.g., BIMO, PAI, etc.)
- Track Key Process Indicators (KPIs) for reporting of Quality
- 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
- Minimum of 3+ years of experience in biopharmaceutical
industry, with the majority in the field quality assurance in the
- Previous GxP quality assurance auditing experience is a
- 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
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
Keywords: Epizyme, Cambridge , Principal Specialist/Manager, GxP Audits & Vendor Management, Executive , Cambridge, Massachusetts
Didn't find what you're looking for? Search again!