Posted to MedZilla on 1/17/2018


Takeda Pharmaceuticals

US-IL, Quality Program Manager 1703308-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 a Quality Program Manager in our Deerfield, IL office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Quality Program Manager working on the Global Quality team, you will be empowered to leads and manages strategic and tactical quality activities associated with the development, manufacture and release of Takeda finished products to ensure compliance with FDA regulations and Takeda expectations, and a typical day will include:

POSITION OBJECTIVES:

  • The Quality Program Manager will oversee Quality System activities at third-party manufacturers/packagers to ensure compliance with current Good Manufacturing Practice (cGMP) regulations and TPUSA quality expectations.
  • The Quality Program Manager will be accountable for QA leadership of investigations into systemic and major product/process non-conformances and deviations to ensure compliant and timely resolution and monitor corrective actions.
  • Represent Takeda Commercial QA during critical projects or start-up activities at third party suppliers to assure all Takeda quality and project expectations are met.
  • Champion the development and implementation of Quality Assurance guidelines, policies, and procedures as necessary to ensure compliance with Federal Regulation.
  • Serve as Quality authority on project teams composed of R&D, Pharm Development, Manufacturing Technology, TPC, Regulatory, Supply Chain, Marketing and others, as appropriate.

POSITION ACCOUNTABILITIES:

  • Works with key vendors to lead or promote initiatives that support market or regulatory changes in support of Takeda products.
  • Lead or assist in audits of proposed suppliers in support of TPUSA commercial product business needs and make recommendations to Takeda management concerning the use of suppliers based on audit findings.
  • May represent Takeda during FDA or other regulatory agency inspections at vendors or TPUSA.
  • Identify process optimization/cost improvement projects for Takeda marketed commercial products and quality systems.
  • Lead or assist in comprehensive Quality Systems audits of existing TPUSA and TPC suppliers to assure continued compliance with cGMPs and Takeda quality expectations.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Minimum 8 years work experience in a pharmaceutical manufacturing, packaging, or laboratory environment, with QA/QC experience strongly preferred.
  • Bachelor s Degree in Chemistry, Engineering, Biology (or related field) or, in lieu of Bachelor s Degree, High School diploma and minimum 6 years of QA/QC work experience in a pharmaceutical manufacturing, packaging, or laboratory environment.
  • Demonstrated teamwork, initiative, and problem solving skills.
LICENSES/CERTIFICATIONS:
  • ASQ or other recognized certification preferred.
PHYSICAL DEMANDS:
TRAVEL REQUIREMENTS:
  • Up to 10% travel required.
  • Domestic and international flights with overnight stays may be required.
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

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.