The Quality Program Manager 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 Quality expectations.
Qualifications EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- Oversee Quality System activities at third-party manufacturers/packagers to ensure compliance with current Good Manufacturing Practice (cGMP) regulations and TPNA quality expectations.
- 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.
- Ensure product integrity, and regulatory compliance through approval of changes to specifications, records, methods and other key quality documentation.
- Lead comprehensive Quality Systems audits of existing TPUSA and TPC suppliers to assure continued compliance with cGMPs and Takeda quality expectations. Lead audits of proposed suppliers in support of TPUSA commercial product business needs. Make recommendations to Takeda management concerning the use of suppliers based on audit findings.
- Identify process optimization/cost improvement projects for Takeda marketed commercial products and quality systems.
- 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.
- Disposition Takeda product for marketplace, as needed.
- May represent Takeda during FDA or other regulatory agency inspections at vendors or TPUSA.
- Additional duties as assigned.
- Bachelor's Degree in Chemistry, Engineering, Biology, or related
- Minimum 6 years of QA/QC experience in the pharmaceutical industry
- Minimum 8 years experience in pharmaceutical manufacturing, packaging, or laboratory environment
- Demonstrated teamwork, initiative, and problem solving skills
- Strong oral/written communication skills
- ASQ or other recognized certification preferred
- Be seated at a desk and perform data review (on paper or a computer screen)
- Due to the requirements of supporting pharmaceutical production operations and conducting audits of third-party suppliers, the work environment includes exposure to production and processing facilities such as:
- Pharmaceutical manufacturing and packaging
- Active pharmaceutical ingredient manufacturing
- Packaging components
- Printed commodities
- Analytical laboratories
- Up to 25% travel required
- Domestic and international flights with overnight stays required
We are driven to improve people's lives.
We are an equal opportunity employer.
No Phone Calls or Recruiters Please.
Takeda Pharmaceuticals - 19 months ago