1+ months

Sr Manager, Quality Assurance

Sunrise, FL 33351
Company Info

If youre like people at Teva, you dare to be different. Were making well-being a way of life for our customers and our colleagues. Join us in helping to make healthcare more accessible to more patients, while supporting one of the most innovative teams in the industry.

Tevas Davie and Sunrise (Florida) production sites are two of our largest launch facilities. We are strengthening and adding to our critical teams with great talent and capabilities. Teva, a global organization, with a brand of evolving success. Be part of it!

We offer a competitive benefits package including Medical, Dental, Vision and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match onthe 401(k), Employee Stock Purchase Plan and Tuition Assistance

Teva is a global pharmaceutical leader and the worlds 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 worlds largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we have 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

 

The Senior Manager of Quality Assurance manages the site's Quality Assurance, Compliance andSupplier Quality team in establishing and maintaining quality in accordance with Site SOPs, Teva GlobalStandards, regulatory guidelines and cGXP compliance requirements. This position is also responsible for several key quality systems, including EDMS, Change Control, and MasterRecord Maintenance.

Key Responsibilities

  • Maintain high standards of quality at the department through managing and continuously improving theeffectiveness of the department processes and systems
  • Share best practices, challenges and lessons learned across the Teva Quality organization in order toimprove the performance of quality globally
  • Evaluate Standards and Regulations SOPs to identify and eliminate gaps in policies
  • Participate in teams that have the technical expertise, personal skills and interpersonal skills needed toinfluence site Operations and is conversant in application of regulations
  • Risk based quality decision making. Review and provide options to meet business needs withoutcompromising quality and compliance
  • Ensures compliance of the site to the Quality Systems and manages the on time completion of QualitySystem actions, investigations, CAPA, coordination of Regulatory commitment, GRAs, Audits
  • Oversees, manages, coordinates and prioritizes the activities of the Quality Assurance Department andassigned staff as required.
  • Review/approve production/process control SOPs
  • Review/approve deviations, CAPAs, Change Controls and other Quality System documentation.
Qualifications
  • Bachelors Degree required, Masters Degree Preferred with a minimum of ten (10) years of experience in a quality position in the pharmaceutical industry and minimum of seven (7) years of experience leading a team
  • Experience with pharmaceutical processes, techniques, and quality assurance expectations
  • Must have working knowledge of relevant regulatory guidances (CFR) and applicable cGMPs andcompliance topics
  • Working knowledge of audit/inspection management, response writing and CAPA management programsstrongly preferred
  • Expertise with Trackwise (gCCM/gCAPA/etc), EDMS (TevaDoc/Wisdom/Master Control) and HPRMdocument management
  • Experience with ERP (Oracle/SAP/etc) and CMMS (EAM) systems a must
  • Knowledge of product release and validation support
  • Experience with Investigations, Change Controls, Product Release, CAPA, Validations is required as wellas Quality Council
  • Ability to communicate technical, regulatory and business issues in a clear, and, when necessary, in a non-technical way
Function
Quality
Sub Function
Manufacturing Quality Assurance
Reports To

Director, Quality Assurance

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.

Categories

Posted: 2020-10-30 Expires: 2020-12-31

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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Sr Manager, Quality Assurance

Teva Pharmaceuticals
Sunrise, FL 33351

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