Description

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Job Description

About the role:

You will manage and ensure that the EBM changes are prioritized in respect to importance, Supporting all bioburden issues that are owned by the QC labs. Support the approval of Submission documents including Please Review, ShEds. Providing support to MS and ensuring the CPV plan and pFMEA's are aligned to the current standards and limits and any investigations related to trends coming out of the CPV plan.

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. You will also own and support Change Controls related to departmental initiatives. You will also support approval of protocols that are not process related (engineering runs/ Cleaning Validation) and work as a back up to the AD QA operations.

You will be the technical trainer for the department in addition to Manufacturing Sciences. During internal and external audits, support the audit as a area SME.

How you will contribute:

Job Function and Description

• This is a very technical position and will involve project and people management skills, and ability to make critical decisions. Willing to learn new aspects of the business.
• Work with different groups (Manufacturing Sciences, Process Engineering, EBM team) and be a back-up for the Associated Director, Quality Operations.
• Manage operating budget for and process improvement projects for the quality organization.
• 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.
• Manage, plan, ensure that the EBM changes are prioritized in respect to importance.
• Support bioburden issues / investigations in your responsibilities that are owned by the QC labs.
• Support the approval of Submission documents including Please Review, ShEds.
• Provide support to MS and ensuring the CPV plan and pFMEA's are aligned to the current standards and limits and any investigations related to trends coming out of the CPV plan.
• 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.
• Own and support Change Controls related to departmental initiatives.
• Approval of protocols that are not process related (engineering runs/ Cleaning Validation) and work as a back up to the AD QA operations.
• Technical trainer for the department in addition to Manufacturing Sciences.
• Support audits as an area SME during internal and external audits.

What you bring to Takeda:

Education and Experience Requirements

• Typically requires bachelor's degree in science, engineering or other related technical field. 8+ years of related experience and 3+ in a management role.

Skills, Abilities, and Competencies

• Critical thinking, working knowledge of statistics and production processes.
• Must have good knowledge about process
• Must have good knowledge about EBM and its working principles.
• Navigate through Track Wise and Veeva

Complexity and Problem Solving

• Decision to accept or reject the documents and investigations.
• Solve issues related to bioburden
• Work with EBM to ensure the EBM changes are prioritized based on criticality.

Internal and External Contacts

• Internal Contacts: QA Operations, QSI lead, EBM / Automation, Manufacturing Sciences, Process Engineering, QC Laboratories, Quality Systems
• External Contact: Regulatory Affairs, Global MS, Product owners, Other facilities to bring best practices to our site.

Other Job Requirements

• Critical thinking
• Independent thinker
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• 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. 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 artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours,.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

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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

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