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Quality Validation Associate Director

Company: Takeda
Location: Thousand Oaks
Posted on: May 3, 2021

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 Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionTakeda 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 performing Quality 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 andResponsibilitiesResponsible 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.QualificationsRequires 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 OthersExhibit 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 ExperienceMinimum 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 EnvironmentNormal 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 applicantsLocationsUSA - CA - Thousand Oaks - Rancho CanejoWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob InfoType: Full timeLocation: USA - CA - Thousand Oaks - Rancho CanejoSDL2017

Keywords: Takeda, Thousand Oaks , Quality Validation Associate Director, Other , Thousand Oaks, California

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