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Job Description
Are you ready to make a meaningful impact on patients' lives and drive innovation within pharmaceutical Quality Control? At Takeda, we strive for excellence in everything we do—and we’re searching for a motivated leader to join our team. If you have a passion for problem-solving, compliance, and optimizing laboratory operations, this dynamic position offers the opportunity to lead initiatives that shape the future of health and science.
About the role
This position is responsible fordetermining the strategy and directing the activities of Microbiology Laboratories at the Los Angeles Facility. This leader has the ultimate responsibility to ensure the implementation and on-going maintenance of prevention-based quality system including deviation management, CAPA, etc. The incumbent will be a member of the Quality Leadership Team (QLT) at the site and develop mid- and long-term strategy. Additionally, will partner up with the manufacturing Business Leaders to drive improvements in safety, quality, compliance, financial performance, employee development, customer satisfaction, and continuous improvement initiatives consistent with the Plant Strategic plan and Takeda values
How you will contribute
Develops and deploys the Quality Systems (e.g. laboratory investigation, out of specification investigations, LIMS, assay validation, management review, CAPA, and process control) that ensure products conform to defined requirements.
Understands and deploys processes to assure conformance to regulations.
Actively leads or presents in regulatory inspections.
Supports the Contamination Control Program for the Los Angeles and Van Nuys Sites.
Responsible for immediate escalation of issues that could impact product quality, safety and/or efficacy to Site Quality Head.
Periodically reviews the suitability and effectiveness of the Quality System with Senior Management.
Interacts frequently with all levels of internal management as well as across functional and business units.
Manages interactions with customers and regulators concerning the quality of products, systems, and processes.
Identifies and manages continuous improvement projects that may span multiple sections or departments with objective of achieving quality, reliability and cost improvements. Actively supports/directs strategies to continuously improve laboratory appearance, laboratory processes and results.
Responsible for adherence to specification and procedures that have been established to ensure product quality in area of responsibility.
Oversees the development and implementation of standards, methods, procedures and sampling for inspection testing and evaluating the precision, accuracy and reliability of the product.
Develop and implement the digital strategy in the Microbiology Laboratories. This may include championing Digital 4.0 elements such as Robotics Process Automation, Predictive Analytics and Paperless Lab.
Leads activities related to the Lab Accelerator and Agile 4.0 initiatives; Ensures consistent implementation of 5S, Standard Work, and Visual Boards.
Provides expertise on and supports data integrity gap remediation and improvements in the Labs.
Develops 3 to 5 year strategy for the function.
Develops operational budget and capital budget for Microbiology organization. Completes budget and adheres to budget/forecast. Continues to determine Value Improvement Projects (VIP) to lower operational costs and improve lab efficiency.
Directs organization of 3-5 direct reports and approximately 30 indirect headcount. Manages overall coaching, training, development and succession plans for the team.
Responsible to drive and support a strong quality culture at the site.
What you bring to Takeda
Bachelor’s degree in Science, Engineering, Chemistry, or related technical field with 7+ years of experience (2+ years in management); Chemistry or Biological Sciences degree preferred.
In depth knowledge of the regulatory environment for manufacture of biological products. Includes strong knowledge of FDA, EMA, and ICH regulations and UISP, EP, and JP requirements.
Strong drive for continuous improvement activities within the lab.
Strong leadership skills and demonstrated success in managing a large team. Ability to build layers of succession within the organization and talent pipeline.
Strong analytical problem-solving skills.
Excellent verbal and written communication skills.
Success working with multifunctional cross facility global teams.
Excellent interpersonal/communication/influencing/negotiation skills required.
Demonstrated problem solving skills.
Important Considerations
Physical demands:
Ability to lift, push, pull, and carry up to 15 lbs. This role includes both sedentary work and walking to observe facility activities.
Working environment:
- Controlled settings requiring special gowning (covering head, face, hands, feet, and body).
- No makeup, jewelry, contact lenses, or artificial nails allowed in manufacturing areas.
- Exposure to cold/wet environments, clean rooms, confined spaces, and temperature-sensitive storage conditions.
- Flexibility to work multiple shifts, weekends, and overtime as required.
- Occasional travel (5%).
What Takeda can offer
We want our employees to succeed in everything they do - at work, at home, and in the community. This is why we offer world-class benefits and access to resources that can support people.
- Comprehensive Healthcare: Medical, Dental, and Vision.
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan.
- Health and 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 a company match of charitable contributions.
- Family Planning Support.
- Professional training and development opportunities.
- Tuition reimbursement.
More About Us
At Takeda, we are transforming patient care through the development of innovative specialty medicines and first-class patient support programs. Takeda is a patient-oriented 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 aims for excellence in everything we do. We promote an inclusive and collaborative work environment where our teams are united by an unwavering commitment to delivering Better Health and a Brighter Future to people worldwide.
EMPOWERING OUR PEOPLE TO SHINE
Takeda is proud of its commitment to creating a diverse workforce and offering equal employment opportunities to all employees and applicants without distinction of race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or any other characteristic protected by law.
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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 - Los AngelesU.S. Base Salary Range:
$137,000.00 - $215,270.00The 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-termincentives. 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 - Los AngelesWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob Exempt
YesLearn more about this Employer on their Career Site
