Associate Director – Analytical Quality Control

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Job Title: Associate Director – Analytical Quality Control
Location: Thousand Oaks, CA

You will be responsible for the strategy and direction of activities within Analytical Quality Control (AQC) which includes, chemistry, HPLC, Drug Substance (DS)/Drug Product (DP) release testing, Quality Lab Services (sample control, lab documentation, change control), product stability ownership, raw material testing, material specification ownership, Utilities testing, and Method Introduction and Support (analytical instrument qualification, method transfer).

Additionally, you will work with manufacturing and product development teams, will participate in proactive functions that impact production, increase efficiency, create cost savings, improve quality, and provide new product support.

• Lead a medium size team of direct (4) and indirect reports (~30).
• Ensure resources, materials, instrumentation are available to achieve product release cycle times.
• Apply Continuous Improvement tools/methods in all aspects of departmental activities.
• Support "Right First-Time" mindset for lab testing and activities.
• Manage operating budget for department.
• Improve accountability within both intra- and inter-departmental teams to ensure project dues dates and deliverables are achieved.
• Be a sponsor for necessary departmental and site projects.
• Implement lab strategic projects 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.
• Prepare department for audits and inspections by both internal and external authorities. Work with investigators during both internal and external inspections.
• Manage overall coaching, development, and succession plans for the team.
• Drive and support a quality culture at the site.
• In-depth knowledge of quality laboratory operations and government regulations about pharmaceutical and medical device manufacturing labs.
• Experience of Statistical Analysis, QSR, cGMP, USP and GDP.
• Promote for continuous improvement activities within the lab.

• Bachelor's in science or other related field required.
• Minimum 8 years of experience in Quality, Manufacturing, or another related field.
• 2 or more years of leadership experience.

• 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 development opportunities
• Tuition reimbursement

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:

• The physical exertion of this position is sedentary work.
• Able to work more than 8 hours a day or 40 hours a workweek.
• Availability after hours and on weekends.
• May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Will need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• May work in a cold, hot or wet environment.
• May work multiple shifts, including weekends, or be asked to work supplemental hours.
• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.

Base Salary Range: $143,500.00 to $205,000.. 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 and Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account many factors including location, skills, education, and experience.

This posting excludes Colorado applicants.

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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.