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Associate Director, Quality Control at Baxalta U.S., Inc. in Thousand Oaks, California

Posted in General Business 30+ days ago.

Type: Full-Time





Job Description:

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Head of Analytical Quality Control in our Thousand Oaks, CA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission

This position is responsible and accountable for management of a department operations budget and a medium size team (~38 HC). The operation is a combination of Analytical Quality Control (chemistry, HPLC, in process, DS/DP release testing), Quality Lab Services (Sample Control, Lab Deviations, Lab Documentation, Change Control), Product Stability ownership, Raw Material Testing and Material Specification ownership, Utilities testing, and Method Introduction and Support (Analytical instrument qualification, method transfer) charged with testing commercial product, intermediates, raw materials to site metrics/ expectations in a full cGMP environment. The Head of Quality Labs is accountable for organizing work to consistently achieve product release cycle time targets and meet project due dates and deliverables in a zero-harm workplace.

Essential Duties and Responsibilities


  • Ensure resources, materials, instrumentation are available to achieve product release cycle times.

  • Application of Continuous Improvement tools/methods in all aspects of departmental activities.

  • Promote and support Right First Time mindset for lab testing and activities.

  • Manage operating budget for department.

  • Consistently drive accountability within both intra- and inter-departmental teams to ensure project dues dates and deliverables are achieved.

  • Serve as sponsor for key departmental and site projects.

  • Execute lab strategic initiatives around team development, analytical method upkeep, and instrumentation/equipment lifecycle management in a global organization.

  • Interpret applicable quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules, and guidelines), and develop policies to implement these requirements for the laboratory operation.

  • Ensure compliance with testing SOPs and specifications.

  • Work closely with manufacturing and product development teams and participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.

  • Engage in Quality Conversations with direct reports and ensure direct reports are engaging in Quality Conversations with their respective teams.

  • Ensure compliance with company procedures/policies.

  • Prepare the department for an audits and inspections by both internal and external authorities. Interface with investigators during both internal and external inspections.

  • Ensure a safe and non-discriminatory working environment for employees.

  • Ensure employees are properly trained and audited. Make appropriate staffing recommendations. Evaluate performance via performance appraisals and ensure employees have development plans.

  • Work with teams of business units and meeting operational goals.

  • May perform other duties as assigned.

Qualifications


  • Must be able to inspire and develop teams

  • Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.

  • Must have the ability of managing complex projects and resolving complex lab issues.

  • Must possess excellent supervisory and interpersonal skills and be able to communicate with all level personnel and regulatory authorities.

  • Should have advanced knowledge in Statistical Analysis, QSR, cGMP, CFR, USP and GDP.

  • Requires strong leadership, project and people understanding of business and/or industry.

  • Knowledge of cGMP manufacturing

  • Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment, and CIP/SIP systems.

  • Knowledge of basic chemical and biological safety procedures.

  • Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.

  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.

  • Must be able to read, write, and converse in English.

  • Must be able to navigate, conduct searches, and complete online forms on Personal Computer for the purposes of training, performance management, and self-service applications.

  • Must have the ability to navigate electronic mail systems and intranet for communication purposes.

  • Must be able to adapt presentation style to match technical level of audience ranging from new workers to senior level management.

  • Advanced word processing, spreadsheet, and PowerPoint skills.

  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.

Education and/or experience

  • BS in science or engineering. 10+ years experience in Quality, Quality Control, Manufacturing, Engineering or related field which should include minimum of 5-7 years of supervisory experience.

Physical Demand

  • The overall physical exertion of this position is sedentary work.

Working Environment


  • Normal office environment.

  • This position may require off-shift, weekend and holiday work. 

  • May be required to travel for business reasons, e.g. training and meetings.

  • Must be able to work in controlled or clean room environments requiring special gowning. May be required to 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 these work environments.

  • May be exposed to dust, gases, and fumes.

  • Possible exposure to cool/hot storage conditions.

  • May be around moving equipment and machinery.

  • May be working in a loud area that requires hearing protection and other protective equipment to be worn.

  • May work around chemicals such as alcohol, acids, and buffers that may require respiratory protection.

  • Inside working conditions.

  • Will interact with other people.

  • Pace may be fast and job completion demands may be high.

WHAT TAKEDA CAN OFFER YOU:


  • 401(k) with company match and Annual Retirement Contribution Plan

  • Tuition reimbursement Company match of charitable contributions

  • 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

Empowering Our People to Shine

This job posting excludes CO applicants.

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 - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





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