Celgene QA Specialist – Inspection Readiness in Bothell, Washington

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Primary Responsibilities:

  • Coordinate pre- and post-inspection activities (e.g. training, functional area readiness, storyboards, etc.)

  • Schedule and conduct mock interviews for subject matter experts (SMEs)

  • Provide guidance to functional representatives before, during and after audits

  • Track action items resulting from audit / inspection observations and drive through to completion

  • Coordinate the self-inspection program including coordination of self-inspection audits, annual planning of audit events, maintaining related SOPs and training of self-inspectors

  • Monitor inspections and provide support, as appropriate

  • Review and facilitate responses to audit reports

  • Distribute inspection data trends to the Quality Unit for management review

  • Review, analyze and distribute regulatory inspection data issued by regulatory authorities (FDA, EMA, PDMA) to ensure proactive compliance across the organization

  • Communicate an inspection preparation plan for the site

  • Develop storyboards, along with functional areas and subject matter experts (SMEs) to be shared during audits for key processes and programs

Basic Qualifications:

  • BS Degree in Life Sciences

  • 5+ years of experience in a regulated environment

  • Experience interacting with FDA or other regulatory agencies (e.g. EMA, PDMA)

Preferred Qualifications:

  • Familiar with all phases of biologic and small molecule drug development.

  • Promote an environment of accountability, diversity and speaking up.

  • Ability to analyze, balance, and prioritize daily activities

  • Experience with GCP/GLP/GMP auditing practices

  • Strong knowledge of federal regulations and other applicable standards

  • Must have strong project management experience with a track record of meeting goals and objectives

  • Must have a strong technical writing skill set and be able to critically review reports

  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.

Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables.

COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE