9 days old

Manager, Quality Professional

Davie, FL 33314
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

Under general direction, oversees operational aspects of the Quality Assurance Department related to the manufacturer of products in strict accordance with all Standard Operating Procedures, current Good Manufacturing Practices, Company policies and procedures, and Food and Drug Administration requirements governing the manufacture of pharmaceutical products.

ESSENTIAL AREAS OF RESPONSIBILITY
All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMPs), and Standard Operating Procedures (SOPs) instructions.
Responsible for completing all training requirements and maintaining 100% compliance with all assignments.
Identify risks and build mitigation plans to proactively resolve project issues.
Manage and resolve conflict and/or issues and escalating as appropriate.
Reviews and approves Validation and Qualification documents including Process, Cleaning, Equipment, Computer, Facilities, Utilities and Packaging.
Reviews and approves change controls.
Reviews and approves manufacturing deviations and CAPAs.
Reviews and approves Equipment Periodic Assessments.
Reviews and approves GxP Assessments.
Reviews and approves FMEA.
Reviews and approves production and process control Standard Operating Procedures (SOPs) that are drafted, reviewed and approved by other organizational units.
Ensures department compliance with and enforcement of SOPs and current Good Manufacturing practices (cGMPs).
Manages Quality systems that support compliant plant operations.
Coordinates with Manufacturing and Packaging Directors and Managers to ensure compliance with and understanding of cGMPs, Company policies and practices, and safety procedures.
Prepares reports for the Director of Quality Assurance and executive management.
Assists direct report supervisors with performance evaluation process for their units.
Provides support, direction, and coaching to peers in the areas of problem resolution, planning, and work assignment delegation.
Ensures project deadlines and performance standards are established and met.
Responsible for performing additional related duties as assigned.

Qualifications

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

 

Education/Certification/Experience:
    Requires Bachelors Degree in a Science or Engineering curriculum.
    A minimum of 7 years relevant progressive experience as a Quality professional in the pharmaceutical manufacturing industry, preferably in solid oral dosage form.
    Prefer direct experience with Health Authority Inspections (FDA/EMA, ANVISA, etc.)

 

Skills/Knowledge/Abilities:
    Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint.
    Must be able to maintain the highest levels of confidentiality, integrity and discretion.
    Excellent verbal, written, and interpersonal skills required.
    Ability to demonstrate sound judgment and decision making.
    Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and or/techniques for resolutions.
    Creating, planning, and implementing goals, objectives, and practices for effective, efficient and cost effective management of allocation resources.
    Responding to technical inquiries from management, employees, and regulatory agencies.
    Communicating clearly and concisely, both, orally and in writing.
    Operating scientific and personal computers.
    Managing multiple projects, duties, and assignments.
    Interpreting and applying Federal, state, and local policies, procedures and regulations.
    Directing, coordinating, delegating assignments and reviewing the work of assigned department personnel.
    Establishing and maintaining cooperative working relationships with others.
    Principles of quality assurance management, leadership, and training.
    Principles of Validation and Qualification, including Computer Validation and Packaging Validation.

 

Function
Quality
Sub Function
Quality Compliance
Reports To

Validation QA Director (Quality Assurance Director)

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: 2020-10-12 Expires: 2020-11-11

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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Manager, Quality Professional

Teva Pharmaceuticals
Davie, FL 33314

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