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Senior Quality Associate of Commercial Operations

Senior Quality Associate of Commercial Operations

Requisition ID 
2017-9886
Job Locations 
US-MD-Rockville

Opportunity Details

Overview

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com.   

 

OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.

Responsibilities

The Quality Associate, Global Product Quality Commercial Products will maintain the quality systems necessary to ensure that functional areas, responsible for the GMP aspects of Commercial products, are operating in full compliance cGMP, approved specifications and Standard Operating Procedures of their department/division. 

 

Additional responsibilities include:

  • Manages the batch record review and release process Global Product Quality Activities supporting Commercial Product (API, drug product, and final finished product).
  • Ensure Quality Systems, including Standard Operating Procedures, Work Instructions, Forms, Templates and other applicable documents, are established and support GMP compliance with regulatory regulations and company policies/procedures specific to Commercial pharmaceutical products.
  • Works collaboratively within the Global Product Quality Dept. and other functions within OAPI, OPDC, other Otsuka companies and contract manufacturers to assure Compliance for commercial products to ensure continuous improvement and compliance.
  • Supports and Improves supplier quality performance for batch record review, release process, to minimize deviations, OOS, and rejects for GMP release of Contract Manufacturers operations (CMOs) supporting Otsuka Commercial Products.
  • Provides quality support to CMOs for the review of process changes and improvements, lead investigation and performed root cause analysis of process deviations, out of trends, and OOS.
  • Escalates project/supplier issues to Management when appropriate to ensure timely resolution
  • Prepares and provides quality metrics to the Management Representative to help in the preparation of Management reviews, quarterly business review meetings with suppliers, and/or other ad hoc reporting requests.
  • Participates in internal audits and commercial supplier audits to ensure compliance with company requirements as well as applicable regulatory requirements.  Writes audit reports and conducts audit follow-up activities as required.
  • Subject matter expert (SME) for assigned commercial products including assistance of complaint reports, change controls, deviations and investigations into Trackwise database to assure proper closure by due date.
  • Participates in preparation and hosting of FDA and other regulatory inspections.
  • Prepares the Annual Product Review (APR) for commercial products
  • Travel (approximately 20%

Qualifications

Required:

  • Minimum of 2 to 5 years in a Quality role supporting manufacturing, packaging, labeling and/or distribution of commercial drug, combination, and device products.
  • Bachelor’s degree in Chemistry, Engineering, Microbiology or other Physical Sciences
  • ASQ Certified Quality Auditor certification (preferred)
  • Ability to handle supplier audit situations and interactions in a tactful, professional and effective manner
  • Ability to manage and prioritize multiple tasks
  • Experience in using TrackWise and Microsoft Office (preferred)
  • Excellent interpersonal and communication (verbal/written) skills
  • Working knowledge of GMP requirements for commercial drug, combinations and device products.
  • Analytical problem solving and decision making skills.
  • Ability to identify gaps/risks and propose corrective and preventative actions.
  • Ability to travel approximately 20%

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