- Manage Quality staff for packaging/inspection operations and material receiving/inspection. Coach, develop and provide feedback to lead individual and team performance.
- Ensure adherence to facility quality systems such as batch record review, product release, change control, exception management, and product annual reviews. Work with manufacturing management in cGMP compliance and quality systems.
- Manage investigations, CAPAs, batch record review, product release, change control, requalification and product quality review associated with Final Packaging organization.
- Manage resources to ensure product/material cycle times are met for supply chain demands. Implement lean concepts to improve cycle times within the area.
- Assure product meets requirements for product and material specifications to applicable geographies. Assure release of product/materials associated with automated device assembly processes and sterilization of medical devices, including Vaporized Hydrogen Peroxide (VHP) sterilization methods.
- Provide direction in the event of manufacturing incidents that may potentially affect quality or compliance. Approval of Product Complaint evaluations.
- Be the quality lead for visual inspection, ensuring compliance, global alignment and meeting regulatory requirements / current industry practices by demonstrating understanding of Visual Inspection and regulatory requirements. Ensure compliance with current regulatory or product license requirements and cGMPs.
- Review and approve changes within the manufacturing area including changes to process, equipment, facilities, procedures, and computerized systems.
- Support the Thousand Oaks facility during external and regulatory inspections. Work directly with the investigators on defending facility quality systems and product investigations.
- Set annual budget and manage resources to meet annual budget, and perform other duties as assigned.
- Bachelor's degree in sciences or engineering.
- Minimum 7 years' experience in a quality operations position in a biotechnology, biologics, or pharmaceutical manufacturing facility.
- Minimum 3 years of leadership, supervisory or management experience desirable.
- Experience in automated device assembly processes and sterilization of medical devices, including Vaporized Hydrogen Peroxide (VHP) sterilization methods.
- The overall physical exertion of this position is sedentary work.
- 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.
- Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- May work in a cold, hot or wet environment.
- May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
- Work more than 8 hours a day or 40 hours a workweek as required.
- Work outside regular business hours and weekends as required.
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Final Drug Product Quality Manager - Thousand Oaks, United States - Takeda Pharmaceuticals
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
Job Title:
Final Drug Product Quality Manager
Location:
Thousand Oaks, CA
About the role:
You will manage the quality daily operations associated with Assembly and Final Packaging.
This is an on site role that reports to the Head of QA Validation.
How you will contribute:
What you bring to Takeda:
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:
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
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.
\#GMSGQ\#ZR1
\#LI-Onsite
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career.
We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - CA - Thousand Oaks - Manufacturing
U
S Base Salary Range:
$108, $170,500.00
The estimated salary range reflects an anticipated range for this position.
The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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 - CA - Thousand Oaks - Manufacturing
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
