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Quality Validation Associate Director

Company: Takeda Pharmaceuticals International GmbH
Location: thousand oaks
Posted on: May 3, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), were leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you.

*Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info.

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 patients.

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.

Success

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 04/20/2021 Location 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 with Takedas 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


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 new products.

Essential Duties and Responsibilities

  • Responsible for leading, managing, coaching/mentoring, training, and developing the Thousand Oaks Quality Validation team.
  • 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 inspections.
  • Evaluate and approve discrepancies related to validations to ensure proper documentation of the incidents and identification of corrective action(s).
  • 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.

Qualifications

  • 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 necessary.
  • 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 validation environment).
  • Minimum of 10-15 years related experience or 8+ years related experience with an advanced degree or demonstrated performance within Validation or Quality Assurance.

Physical Demand

  • The overall physical exertion of this position is sedentary however gowning and working in controlled manufacturing areas will be required.

Work Environment

  • Normal office environment.
  • Requires shift, weekend, and holiday work.
  • May be required to travel for business reasons, e.g., training and meetings.
  • 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 environments.
  • 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

Locations

USA - CA - Thousand Oaks - Rancho Canejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0032723

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.

Copyright 1995-2019 Takeda Pharmaceutical Company Limited. All rights reserved.

Keywords: Takeda Pharmaceuticals International GmbH, Thousand Oaks , Quality Validation Associate Director, Other , thousand oaks, California

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