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Principal GxP Auditor

Company: Karyopharm Therapeutics
Location: Newton
Posted on: June 8, 2021

Job Description:

Responsibilities

The Principal GxP Auditor is responsible for leading the vendor management program for Karyopharm GxP Quality and for presenting the program during regulatory inspections. The individual is also responsible for planning, conducting, and closing vendor audits to assess Karyopharm's CMOs level of compliance with GMP regulations, guidelines, internal procedures and best industry practices. This individual acts as primary contact point for all audit related communication with vendors.

  • Develop GMP audit plan per Karyopharm internal procedures
  • Execute internal and external audits according to approved audit schedule; negotiate audit date, prepare and send agenda to auditee
  • Write audit report and observations letter, issue audit follow-up documents in timely manner
  • Evaluate auditee's responses, communicate on compliance issues and corrective action surrounding audits
  • Make and document decision for supplier qualification status, estate critical findings to Sr. Management
  • Write, revise and review procedures for the supplier management program
  • Document audit observations and CAPAs in electronic system
  • Maintain approved supplier list
  • Drive closure of CAPA resulting from audits, as needed
  • Participate in regulatory audits, PAI readiness audits and inspections as directed by QA Management
  • Review supplier change notifications and work with stakeholders to determine impact to internal systems.
  • Support Technical Quality Agreements management, write TQAs using internal template, and communicate with suppliers for comment resolution
  • Participate in cross site projects, as needed
  • Provides back-up for the QA department in selected areas, as needed
  • Up to 50% travel, domestic and international (1-2 vendor audits per month)

Qualifications

  • BS / MS in a scientific or engineering discipline
  • 5 years experience in pharmaceutical / biotech industry within Quality Assurance executing audits
  • Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices.
  • Knowledge of FDA and EU cGMP requirements
  • Ability to write and revise documents.
  • Ability to use judgment in situations for which there are no precedents.
  • Outstanding communication skills (verbal and written)
  • Ability to manage multiple projects in a fast-paced environment
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.

Overview

Karyopharm Therapeutics Inc. (NASDAQ: KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound, XPOVIO (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the European Commission. In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.

Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company's Human Resources department.

Keywords: Karyopharm Therapeutics, Newton , Principal GxP Auditor, Other , Newton, Massachusetts

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