Manager- Quality Assurance at Baxalta U.S., Inc. in Round Lake Beach, Illinois

Job Description:

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Job Description

About the role:

Round Lake is a large volume pharmaceutical manufacturing facility responsible for filling life-saving plasma-derived therapeutics. The Quality Control Manager will work as part of a cross-functional team providing leadership and oversight to quality assurance and quality control operations function, and drive compliance to regulations and global policies. Key responsibilities also include managing a team and engaging and working collaboratively across the site.

How you will contribute:

• Manage Quality Control (QC) and Sterility Assurance functions. Provide performance coaching and feedback to team members.

• Ensures Quality Control & Microbiology records are properly evaluated, and the integrity of analytical data maintained.

• Manage microbiological environmental monitoring (EM), in-process bioburden, final container sterility, sterilization process qualifications, aseptic process simulations (media fills) and critical utilities testing and respective requirements, ensuring that quality systems, processes and related functions are in place and meet cGMP, Takeda, and other regulatory quality standards and requirements.

• Implement authorities' requirements regarding microbiological relevant topics (EM, product bioburden, media fill, hygiene topics, aseptic behavior, etc.) and compliance with regulations to ensure contamination control in the manufacturing areas.

• Responsible for the site's Contamination Control Plan.

• Complete gap assessments, remediation plans and implement global procedures on sterilization, aseptic processing, and environmental monitoring.

• Under the guidance of the Site Quality Head, present topics such as aseptic processing, EM, media fills, disinfectant validations, and contamination control during internal/external regulatory inspections.

• Create and maintain escalation process for quality and safety issues.

• Support continuous improvement initiatives in collaboration with the Site Quality Services & Improvement (QS&I) function and Site Quality Head. This includes development and introduction of new technologies to maximize efficiency and reduce the risk of sample contamination (e.g., NovaSeptum, rapid micro methods).

• Own the scheduling, prioritization, and delivery of testing from 3rd-party laboratories.

• Ensure timely availability of test results and data trending from 3rd-party laboratories.

Minimum Requirements/Qualifications:

• Typically requires bachelor's degree, preferably in science, engineering, or other related technical field.


• 6+ years of related experience with 1+ years as a supervisor


• In-depth knowledge of applicable regulations and laws for biological products, such as FDA CFR, cGMP, EU GMP, MD, EU Directives and guidelines


• Provide leadership and oversight in terms of product quality and conformance to regulations and Takeda quality policies and procedures, and continuously develop people and teams.


• Ability to handle multiple projects or workstreams.


• Demonstrates effectiveness in task completion, decision-making, empowerment of others, deviation/nonconformance management, training, problem solving and team leadership.


• Strong leadership and collaboration skills with demonstrated success managing a multi-level team.


• Identifies and manages continuous improvement projects with the objective of achieving quality, reliability, and cost improvements.


• Interacts frequently with internal subordinates, functional peers, and senior group managers.


• Responsible for coaching, training, and development team.


• Solid laboratory technical background and knowledge of main analytical tools.


• Knowledge of requirements related to microbiological quality control and sterility assurance/aseptic processing (local and global SOPs, cGMP, CFR, Pharmacopeia (US/ China/EU).


• In-depth knowledge of applicable regulations and laws for biological products.


• Strong Microsoft Office (Word, Excel, PowerPoint) skills.

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 paid time off for vacation, sick leave, and volunteering


• Community Outreach Programs and company match of charitable contributions


• Family Planning Support


• Professional development and training opportunities


• Tuition reimbursement

Important Considerations

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. In this role, you may:

• Indoor working conditions


• Must be able to work in controlled GMP areas and be aware of requirements and risks associated with laboratory environment, classified manufacturing areas and aseptic processing and contamination control


• No make-up, jewelry, nail polish or artificial fingernails may be worn in the manufacturing environment.


• May work in a cold and/or wet environment.


• Some Clean Room and cool/hot storage conditions.


• Ability to manage hazardous and biologic materials


• Ability to walk 1-3 miles and be able to be sedentary for an extended period of time

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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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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 - IL - Round Lake - Drug Delivery

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time