Manager, Quality Assurance
Company: Takeda Pharmaceutical
Location: Social Circle
Posted on: August 7, 2022
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
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
- 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
- You will learn new aspects of the business and refer to
regulations (USP, CFR, Eudralex). You will act as a Change
- 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
- 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
- Manage and support Change Controls related to departmental
- QA Approver of protocols that are not process related
(engineering runs/ Cleaning Validation),
- Support audits as an area subject matter expert (SME) during
- 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
- Working knowledge of statistics and production processes.
- Must have process knowledge
- Must have good understanding about EBM, PCS, and other
- 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
- Experience with automation and electronic batch management
systems and prioritization for automation and EBM changes based on
- 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
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- 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,
- 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
- 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
Keywords: Takeda Pharmaceutical, Athens , Manager, Quality Assurance, Executive , Social Circle, Georgia
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