Quality Program Manager - United States
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:
- 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.
- 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: 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.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
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.