Head of Quality Control Labs- LA Site - Now Hiring

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Job DescriptionAbout the role:You will direct the Quality Control Laboratories (Microbiology, Biochemistry, Method Introduction & Support (MI&S) and Lab Compliance and Support groups) in a large size department so support Facility and Corporate wide programs at the Los Angeles and Van Nuys Facilities. Responsible for QC results regarding product Quality and Conformance to Regulations and Takeda policies. Additionally, this leader has the ultimate responsibility to ensure the implementation and ongoing maintenance of prevention-based Quality Control Systems (i.e., , Lab Investigations, out of specification investigations exception management, CAPA, Method and Instrument Validations through Change Control) You will be a member of the Senior Leadership team at the site and develop mid- and long-term strategy for the QC organization that is consistent with the Site and Quality Strategy. You will partner up with the Manufacturing Business Leaders to improve Safety, Quality, Compliance, financial performance, employee development, customer satisfaction, and digital and continuous improvement programs consistent with the Plant and OpU Strategy. You will uphold Takeda's Quality Culture elements of keeping it simple, taking pride in doing it right, ensuring a speak up culture and managing and demonstrating commitment to Quality.How you will contribute:

• Develop and deploy the Laboratory 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.
• Responsible for oversite of the entire testing laboratory which supports testing of Raw Material, Environmental Monitoring, In-Process, and Final Container/ Stability testing.
• Understand and deploy processes to assure conformance to regulations. Lead and present in regulatory inspections.
• Periodically review the suitability and effectiveness of the Quality Control Labs and System with Executive management.
• Interacts frequently with all levels of internal and external management with frequent cross functional and network communication.
• Support network programs and community of practice (CoP) operating mechanisms.
• Drive understanding of QC Heads across Plasma Operating Unit regarding test method harmonization and exchange of best practices.
• Manage interactions with customers and regulators concerning the testing and quality of products and processes.
• Lead continuous improvement projects that may span multiple sections or departments with the objective of achieving Quality Lab excellence/ Lab House, instrument reliability, sample/assay invalid reduction and overall laboratory cost improvements.
• Supports/ directs strategies to improve laboratory appearance, laboratory processes and results.
• Responsible for adherence to specification and procedures that have been established to ensure product Quality.
• Oversee and provide technical input to the development of standards, methods, procedures and sampling for inspection testing and evaluating the precision, accuracy and reliability of the test methods to ensure test results meet defined criteria.
• Develop a 3 to 5-year strategy for the lab organization with focus on digital innovation (becoming connective, then predictive, then adaptive), QC Network Strategy (stand-alone testing facility), maintain Data Integrity & 5S complaint and continue lab excellence journey.
• Develop operational budget and capital budget for Quality Control organization. Complete budget and follows budget/ forecast. Continue to determine Value Improvement Projects (VIPs) to lower operational costs and improve lab efficiency and operation.
• Direct organization of 4-5 direct reports (Associate Director/Managers) and approximately 100 indirect headcounts. Manage overall coaching, training, and succession plans for the team.
• Member of the Facility Senior Leadership Team (SLT) and Quality Leadership Team (QLT).
• Demonstrate the Takeda Leadership Behaviors and values. Also, make decisions using the PTRB (Patient, Trust, Reputation & Business) lens.
• In depth experience in Quality Control Operations and the regulatory environment for manufacture and testing of biological products. Includes knowledge of FDA, EMA, CFDA and ICH regulations and USP, EP, CHP and JP requirements.
• Drive for continuous improvement activities within the lab.
• Strong leadership skills and demonstrated success in managing a large team. Build layers of succession within the organization and talent pipeline.
• Strong Quality Control analytical problem-solving skills.
• Success working with multifunctional cross facility global teams.
• Excellent interpersonal/ communication/ influencing/ negotiation skills required.

What you bring to Takeda:

• Typically requires bachelor's degree in chemistry, biological science, or other related technical field. 10 years of related experience with 7 in a management role
• Must be able to lift, push, pull and carry up to 10 lbs.
• In general, your work will be a combination of sedentary work and walking around observing conditions in the facility.
• Will work in controlled environments requiring special gowning.
• Will follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work in a cold and wet environment.
• Must be able to work multiple shifts, including weekends.
• May be required to work in a confined area.
• Some Clean Room and cool/hot storage conditions.

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

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.Empowering our people to shine: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.Base Salary Range: $160,300.00 to $229,000.00. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.#GMSGQ #ZR1

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.

LocationsUSA - CA - Los AngelesWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time