Quality Assurance Director at Baxalta U.S., Inc.

Posted in General Business 7 days ago.

Type: Full-Time
Location: Los Angeles, California





Job 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

About the role:

This position determines the strategy and directs the activities of Quality Assurance and Product Release for Fractionation, Purification, Engineering/ Facilities and Receiving and Inspection and Warehouse departments in the Los Angeles and Van Nuys Facilities. Additionally, this leader has the ultimate responsibility to ensure the implementation and ongoing maintenance of prevention-based Quality Systems (i.e., exception management, CAPA, and Change Control) and Quality on the Shop Floor. You will be a member of the Senior Leadership team at the site and develop mid- and long-term strategy for the QA 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 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:


  • Manage the Quality organization in a large size plant specific to Quality Assurance and Product Release for Fractionation, Purification, Engineering/ Facilities and Receiving and Inspection and Warehouse departments in the Los Angeles and Van Nuys Facilities. Create an organization where Quality, Manufacturing and Engineering practice Quality on the Shop Floor collaboration to ensure sound Quality decisions are made with compliance to Takeda standards and procedures.

  • Assume final accountability for all product quality release decisions.

  • Ensure compliance to all applicable state, federal, and international regulations.

  • Manage interactions with internal external customers concerning the quality of products and processes.

  • Develop and deploy mid- and long-term strategy for, operational excellence, digital innovation training, talent succession planning and personnel development.

  • Serve as the primary contact for all inspections and audits of in-process quality management, exception management and CAPA.

  • Direct the ongoing continuous improvement and digital programs.

  • Staff the department to ensure compliance to all process quality requirements following the quality plan.

  • Manage overall coaching, training and succession plans for the team.

  • Develop and ensure adherence to the department budget

  • Knowledge of FDA, EMA, CFDA, PDA Regulations, application of Good Data and Documentation Practices (GDDP) and application of current Good Manufacturing Practices (cGMP).

  • Knowledge of the manufacturing operations, applicable procedures, specifications and Takeda standards.

  • Analytical and problem-solving skills.

  • Manage a large team of employees.

  • Demonstrated problem solving skills.

  • Prior experience working and leading regulatory audits.

  • Manage department budgets and staffing.

  • Yellow Belt/ Green Belt training/ Lean certification.

  • Living our ethical principles and leadership behaviors is a basic expectation for all Takeda employees

What you bring to Takeda:


  • Typically requires bachelor's degree in science, engineering or other related technical field. 10+ years of related experience with 7+ in a management role. Bachelor's Degree in Chemistry or Biological Science.

  • 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 cGMP 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, which in some areas is cold and wet, and require personal protective equipment (PPE).

  • May work in a confined area.

  • Some Clean Room and cool/hot storage conditions.

  • Must be able to work multiple shifts, including weekends.

  • 10% 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 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.

Location and Salary Information:

#GMSGQ #ZR1

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.

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 Angeles

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





More jobs in Los Angeles, California


The Whiting-Turner Contracting Company

Southern California Hospital at Hollywood

Southern California Hospital at Hollywood
More jobs in General Business


Caesars Entertainment

RetailData

Padagis US LLC