Posted to MedZilla on 1/22/2018


Takeda Pharmaceuticals

US-MA, Oncology & Biologics Quality Compliance Specialist III 1800124-MZ


 
 

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Oncology & Biologics Quality Compliance Specialist III in our Cambridge, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Oncology & Biologics Quality Compliance Specialist III working on the Quality Compliance team, you will be empowered to works cross-functionally with other departments, Takeda Alliance Partners and Affiliates to ensure thorough investigation plans are developed and executed for timely and compliant closure. A typical day will include:

POSITION OBJECTIVES:

  • The Oncology & Biologics Quality Compliance Specialist III will be responsible for coordinating/performing assigned investigations including drafting excursion reports for review.
  • Oncology & Biologics Quality Compliance Specialist III is responsible to participate in assigned project teams as Quality Compliance lead representative.
  • Responsible for drafting and implementing SOP s, Work Practices, Quality Agreements as they pertain to product complaint investigations and other documents as assigned.
  • Responsible for managing own workload from multiple project managers to meet deadlines.

POSITION ACCOUNTABILITIES:

  • Product Complaint System Oversight will include the following:
  • Performs and/or coordinates the receipt, processing, monitoring and reporting of product complaints.
  • Addresses and expedites product complaints under the company s product complaint policy and procedures, and ensuring compliance with federal regulations.
  • Log and maintain currency of product complaint documentation utilizing the product complaint tracking database.
  • Coordinate the activities required to investigate and close Commercial product complaints, which includes following-up with Takeda s contract call center and/or complainants, and facilitating cross functional product complaint sample inspections and analyses by applicable Takeda departments and Alliance Partners.
  • Author and send Commercial complainant responses per established procedures and timelines.
  • Monitor and analyze product complaint data for trends, ensuring that appropriate corrective action plans are developed and routine status and trending reports are distributed to management.
  • Escalates to management (as applicable), any identified risks, improvement opportunities and/or compliance concerns associated with the product complaint system. Provides suggestions to appropriate company authorities to modify existing manufacturing or packaging processes based upon pattern and related analyses.
  • Co-facilitates periodic review meetings between Pharmacovigilance, Medical Affairs, Commercial Operations and Quality per Takeda procedures to ensure consistency of processing and reconciliation of product complaints and adverse events.
  • May attend weekly Case Review Meetings (routinely) and Signaling Meetings (when applicable as backup), providing input on behalf of Commercial Quality Operations
  • Provide support for regulatory inspections and GMP audits
  • Responsible for engaging in regular contact with external organizations and Takeda Affiliate Offices.
  • Serve as cross-functional Lead representative and is responsible for independent technical and non-technical troubleshooting.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • BS and 4-6 years experience with 2 in Quality Assurance/Quality Complaince or related compliance experience or MS and 2+ years Quality Compliance experience. Experience may be substituted for degree.
  • Solid understanding of applicable regulations and guidances. Demonstrates expertise of department processes, tools and methods.
  • Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
  • Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
  • Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings or client sites, including overnight trips
  • Requires approximately 0-10% travel
WHAT TAKEDA CAN OFFER YOU:
  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.


Schedule


Please visit our website at takedajobs.com

 
 


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