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Every day, employees working in Takedas Global Manufacturing and
Supply Chain, and Global Quality business unit are shaping the
future of healthcare. They are breaking down barriers and ensuring
our life-changing medicines are available, accessible, and
affordable to patients. Life-changing for you. Life-changing for
Global Manufacturing and Supply Chain, and Global Quality is the
backbone of Takeda, and our employees are the guardians for our
patients, our products, and our reputation. As a member of our
team, we can offer you the opportunity to grow in a meaningful
career, develop your skills, and come to work every day knowing
that what you do makes a genuine difference.
What makes a successful member of our team? Check out the traits
were looking for and see if you have the right mix.
Quality Validation Associate Director
Apply Now Job ID
R0032723 Date posted
Thousand Oaks, California
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
that all information I submit in my employment application is true
to the best of my knowledge.
Takeda is a patient-focused, values-based, R&D-driven global
biopharmaceutical company committed to bringing Better Health and a
Brighter Future to people worldwide. Our passion and pursuit of
potentially life-changing treatments for patients are deeply rooted
in over 230 years of distinguished history in Japan.
Every vial has a name is a core value at our Thousand Oaks CA
campus, a multi-product facility with over 20 years of operational
expertise. We have an excellent opportunity for a high
performingQuality Validation Associate Director.
Manages the Quality Validation resources onsite, drive
continuous improvement, and standardization of Quality Validation
across the Takeda Thousand Oaks site. Ensure that the validation
and compliance requirements are met according to internal and
external guidelines. Proficient in facility quality systems and
participates as a subject matter expert of validation requirements.
Review qualification/validation activities linked to all parts of
the business (Drug Substance and Drug Product manufacturing,
Finishing operations, Automation, Process, Cleaning, Method
Transfer, Analytical Instrument, Facilities, Utilities, Equipment,
and Systems, and Transportation). In addition will be responsible
for ensuring all validation activities are performed correctly for
Essential Duties and Responsibilities
- Responsible for leading, managing, coaching/mentoring,
training, and developing the Thousand Oaks Quality Validation
- Provide Quality Validation oversight for the introduction of
new products to the Thousand Oaks site.
- Responsible for reviewing and approving validation documents
(e.g., test plans, protocols, reports, Validation Project Plans,
Qualification Project Plan) and other related documents to ensure
compliance to internal procedures and regulatory requirements.
Ensure that the information contained in the approved validation
document(s) is understandable and defendable during
- Evaluate and approve discrepancies related to validations to
ensure proper documentation of the incidents and identification of
- Collaborate and participate in CAPEX and OpEx projects as the
Quality Representative for commissioning and validation activities.
Provide validation expertise and support for the development or
modification phases of facility, utilities, equipment, system,
computerized system, and process.
- Support internal and external audits as required.
- Provide Change Control and/or Deviation assessment and support
in the review of risk assessment(s) as required.
- Collaboration with other sites and global in enhancement and
harmonization of validation requirements.
- Responsible to adhere to any applicable EHS requirements.
- Provide quality oversight for validation maintenance.
- All other duties as assigned.
- Requires a proven track record of staff oversight, setting
validation policy, and working closely with senior management.
- Requires excellent analytical skills with systematic approaches
to problem solving. Must be able to break down complex problems and
tasks into activities capable of being performed by personnel.
- Current understanding of pharmaceutical industry regulations
and trends in the regulatory environment.
- Strong interpersonal communication skills with excellent
technical writing abilities.
- Strong interpersonal skills and attention to detail are
- Exhibit leadership behaviors of Be Positive, Be Accountable, Be
Results Oriented, and Be Excellent Manager of Self and Others
- Exhibit Takeda-sim of Integrity, Fairness, Honesty, and
Perseverance through actions based on putting patients first,
building trust with society, reinforcing our reputation, and
developing a sustainable business.
Education and/or Experience
- Minimum of BS or BA preferably in the Sciences/Engineering/Math
(other degrees accepted provided the individual has relevant
experience e.g., education or employment in the science or
- Minimum of 10-15 years related experience or 8+ years related
experience with an advanced degree or demonstrated performance
within Validation or Quality Assurance.
- The overall physical exertion of this position is sedentary
however gowning and working in controlled manufacturing areas will
- Normal office environment.
- Requires shift, weekend, and holiday work.
- May be required to travel for business reasons, e.g., training
- Must be able to work in a controlled/clean room environment
requiring special gowning. Will be required to follow gowning
requirements and wear protective clothing over the head, face,
hands, feet, and body. No makeup, jewelry, contact lenses, nail
polish, or artificial fingernails may be worn in these work
- Must be able to work more than 8 hours a day or 40 hours a
workweek, as required.
- Will have interactions with other people.
- Pace may be fast and job completion demands may be high.
LOCATION AND SALARY INFORMATION:
This job posting excluded CO applicants
USA - CA - Thousand Oaks - Rancho Canejo
Check out where you could be
working if you apply.
Job Seekers: Protect yourself against identity theft
Please be aware there are instances of identity thieves posting
Takeda-branded jobs and posing as employees to steal personal
information. They visit job-related websites and invite candidates
to online chats. During the chat, they press job seekers to provide
bank account information and Social Security numbers.
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