Manager, Quality Assurance

Company: Takeda Pharmaceutical
Location: Social Circle
Posted on: August 7, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description About the role: As the Manager, Quality Assurance Fractionation (Projects), you will support site initiatives and projects impacting multiple manufacturing areas. You will manage/plan and support to ensure that EBM and other automation changes are prioritized in respect to compliance and site projects and support bioburden investigations and rDMAIC in the area of responsibility that are owned by the QC labs. You will also support authoring, review and approval of Regulatory submission documents related to site projects and audit responses. You will also provide support to Manufacturing Sciences (MS) by the CPV plan and pFMEA's are aligned to the current standards and limits and supporting investigations related to trends coming out of the CPV plan reviews.You will also manage departmental process improvement projects and provide support to QSI in Quality initiatives. You will also communicate with sister facilities and bring best practices to our site and own and support Change Controls related to quality departmental initiatives. You will also support approval of protocols that are not process related (engineering runs/ Cleaning Validation) and provide support for quality oversite, deviations and process related protocols for respective manufacturing areas. You will also support Internal and Regulatory Audits as a subject matter expert (SME) or in the audit room. How you will contribute:

• This is a very technical position and will involve project and people management skills.
• Manage departmental process improvement projects and provide support to QSI in Quality initiatives.
• Communicate with sister facilities and bring best practices to our site and own and support Change Controls related to quality departmental initiatives.
• Support approval of protocols that are not process related (engineering runs/ Cleaning Validation ) and provide support for quality oversite, deviations and process related protocols for respective manufacturing areas.
• Develop, maintain, and manage QA Operations and technical training programs.
• You will learn new aspects of the business and refer to regulations (USP, CFR, Eudralex). You will act as a Change Champion.
• Will work with different groups (Manufacturing Sciences, Process Engineering, EBM team).
• Develop and manage operating budget for and process improvement projects for the quality organization.
• Support and ensure compliance with global standards and company policies. Perform pre-audits before and identify gaps and risks for both internal and external audits.
• Provide quality representation in EAC meetings and support any actions that maybe needed regarding contamination control (product / microbial)
• Ensure the departmental SOPs, JA's, are current.
• QA support of site initiatives and projects affecting multiple manufacturing areas; manage, plan, support and ensure that EBM and other automation changes are prioritized in respect to compliance and site initiatives.
• Support bioburden issues / investigations in the area of responsibility that are owned by the QC labs.
• Support the review and approval of Submission documents including Please Review, ShEds.
• Quality support to Manufacturing Sciences for CPV plan and pFMEA's are aligned to the current standards and limits; support any investigations related to trends coming out of the CPV plan.
• Manage and support Change Controls related to departmental initiatives.
• QA Approver of protocols that are not process related (engineering runs/ Cleaning Validation),
• Support audits as an area subject matter expert (SME) during all audits.
• Able to communicate to manage support personnel.
• Can balance multiple projects while meeting all timelines. What you bring to Takeda:
  • Typically requires bachelor's degree in science, engineering or other related technical field.
  • 8+ years of related experience and 3+ in a management role.
  • Working knowledge of statistics and production processes.
  • Must have process knowledge
  • Must have good understanding about EBM, PCS, and other automation systems.
  • Can resolve compliance and manufacturing process issues
  • Technical problem solving skills required
  • Can understand risks based on manufacturing science and compliance and be able to make risk based decisions.
  • Must be knowledgeable about bioburden and contamination control.
  • Experience with automation and electronic batch management systems and prioritization for automation and EBM changes based on criticality.
  • 5% Travel What Takeda can offer you:
    • Comprehensive Healthcare: Medical, Dental, and Vision
    • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
    • 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 and company match of charitable contributions
    • Family Planning Support
    • Professional training and development opportunities
    • Tuition reimbursement Important Considerations At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
      • Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
      • Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
      • Must have some flexibility in work hours for work on weekends or holidays More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This posting excludes Colorado applicants. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations USA - GA - Social Circle - Hwy 278 Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Athens , Manager, Quality Assurance, Executive , Social Circle, Georgia