1+ months

Senior Manager, Validation

West Chester, PA 19380

Company Info

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

Tevas Global Research & Development (R&D) organization is devoted to the development of new medicines, devices and combination products that provide meaningful therapeutic benefit to patients worldwide. Combining creativity, scientific rigor and our extensive knowledge on a broad range of technologies, our scientists, engineers, medical doctors and project leaders across the globe use their expertise to innovate novel biologics, biosimilars, small molecule specialty medicines, generics and over-the-counter therapies.
 

As the Senior Manager, Validation will lead a team of internal and contracted validation staff and will be responsible for end-to-end management of manufacturing and laboratory equipment validation and qualification activities for Tevas Biologics R&D groups located at West Chester, PA. This role requires working at all levels of the organization to lead ensure the timely development, execution and approval of all validation programs in accordance with regulatory requirements, specifically process, cleaning, and equipment validation.

 

You will be responsible for the implementation of the site validation program, ensuring its continuous updates and process improvements to align with regulations. You will also prepare and execute process validation documents to ensure that activities and reports intended for commercial products are fully compliant.

 

Other duties:

  • Author, execute and manage performance process validation studies for biologics products including compilation of data, investigations, and results into final reports
  • Provide technical oversight of the process, equipment, facility and cleaning validation program
  • Maintain departmental compliance pertaining to departmental SOPs, the revalidation program, change controls, deviations, CAPAs, etc. 
  • Manage full time validation staff and contractors
  • Ensure site alignment with corporate standards and cGMP guidelines
  • Upkeep of validation standard operating procedures.  Authoring and revising procedures within the electronic documentation management system
  • Creating and updating validation master plans and project timelines
  • Provide quality metrics and project metrics
  • Technically independent and maintains up-to-date knowledge of validation standards and regulatory compliance requirements.  Independently contributes to development of new site validation standards
  • Work independently and/or with subject matter experts to implement and/optimize key validation and quality initiatives
  • Support internal and external inspections for all GxP departments, such as QC, Manufacturing, Devices, GLP labs, Warehousing, etc.
  • Responsible for owning and/or supporting deviation generation, investigation, and CAPAs
  • Responsible for owning or evaluating change controls associated with validated systems, facility, or processes
  • Support continuous improvement projects and activities

Qualifications

What you will bring to the role:

  • Bachelors degree in life science or engineering
  • Minimum 7 years Validation experience in Biopharmaceutical products, or combination of Validation and Engineering/Commissioning experience
  • Minimum 1 year of experience in leadership role 

 

Preferred Qualifications:

  • Masters degree
  • Minimum 10 years or more years in combination of Validation and Engineering/Commissioning experience
  • Minimum 3 years of direct Validation oversight experience
  • Experience in process validation, manufacturing systems, cleaning validation, data integrity, and analytical equipment
  • Experience of successful interfacing with Quality, Operations, Scientists and Information Technology groups to develop requirements, establish programs and manage day-to-day operation
  • Understanding of utility systems, process instrumentation, automation systems, and analytical equipment
  • Validation experience with production equipment, utility systems, computerized systems/automation, SIP/CIP, and cleaning verification 
  • Experience in software systems such as Trackwise and CMMS

Function

Sub Function

Reports To

Associate Director, Validation

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to  support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.  

Categories

Posted: 2021-02-08 Expires: 2021-04-24

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Senior Manager, Validation

Teva Pharmaceuticals
West Chester, PA 19380

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