Job Information
Teva Pharmaceuticals Senior Manager EMSO Quality in Parsippany, New Jersey
Senior Manager EMSO Quality
Date: Apr 15, 2024
Location:
Parsippany, United States, New Jersey, 07054
Company: Teva Pharmaceuticals
Job Id: 53193
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
The role is accountable to ensure deliverance of revenue and free cash flow for complex products (including combination products) within the EMSO Americas division, including committed Customer Service Levels and On-Time In-Full (OTIF) targets, while ensuring compliance targets. They are accountable to manage the quality activities for the device components, drug components and finished products produced by Teva’s Third Party external manufacturing and packaging partners. They are accountable to ensure the product meets established standards of quality including reliability, usability, and performance. Ensures ongoing compliance with quality and industry regulatory requirements for 21CFR 820 and 21CFR Part 4, as well as 21CFR Parts 210/211.
How you’ll spend your day
Collaborate with suppliers to ensure their compliance and the quality of their products, materials, components and/or operations.
Analysis and development of specifications and test methods with both external and internal business partners (change controls, release documents, and other applicable documentation) to confirm and sustain compliance to 21 CFR Parts 4, 210 and 211.
Review, evaluate and approve change controls from Third Party Suppliers and act as the point of contact for all comments between internal departments and the site.
Manage product quality complaint investigations and determine if regulatory notification (ex. FAR or BPDR) is required.
Development and presentation of product data to management in support of changes. Maintenance of product files.
Participate in Quality Councils and Management Review for SRT, including tracking and managing actions for Complex products.
Manage KPIs and prepare presentations for Complex meetings as required.
Visit CMOs to resolve critical issues, including audits of products.
Receive and review quality customer complaint investigations, nonconformance reports and laboratory investigations, ensuring all necessary components are included.
Ensure annual stability testing is being performed as per regulatory requirements.
Compile data from third party suppliers for the preparation of annual product review.
Participate in root cause analysis and prepare written investigations for deviations/NCRs. Follows up with suppliers on quality deviations and ensures solutions are identified and implemented, including those from supplier audits.
Attend all daily/weekly operational and quality meetings in support of Complex products.
Development of processes and procedures to support QMS.
Your experience and qualifications
Bachelor’s degree in Science or Engineering with a minimum of ten (10) years’ experience in aseptic processing and/or combination products.
Must have in-depth knowledge of the QSR CFR Part 820, Part 4, and ISO13485 & 14971 regulations, and desired experience with CFR Part 210/211, ICH and applicable international regulations/guidelines.
Experience with investigations, change controls, product release, validation, CAPA, is required.
Strong technical writing skills.
Ability to resolve complex problems and contribute to improvements and solutions.
Experience with Quality Systems such as electronic deviations (ex. Trackwise) and documentation management systems, SAP, and serialization.
Experience with external pharmaceutical manufacturing, packaging, testing and release is desired.
Strong computer skills including TrackWise, Oracle and SAP is desired.
Ability to set appropriately set priorities and work independently with minimal guidance.
Key Competencies
Quality: attention to detail and accuracy, committed to excellence, suggests improvements to existing process, identifies root causes, owns and acts on quality issues.
Integrity/Ethics: Deals with others in a straightforward and honest manner, is accountable for own actions, maintains confidentiality and supports company values.
Teamwork: meets all team deadlines and responsibilities, listens and values other’s opinions and acts as a resource for colleagues with less experience.
Customer Focus: represents Teva in a professional and positive manner. Sets expectations of quality, solicits opinions and ideas and responds to customer quality inquiries.
Adaptability/flexibility: adjusts plans to meet changing needs, open to new ideas, takes on new responsibilities.
Able to:
Communicate well both in verbal and written communication.
Collect, manage and analyze data.
Analyze and solve problems using existing solutions.
Plan, prioritize and organize with minimal management oversight.
Enjoy a more rewarding choice
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, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
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 (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)
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’s Equal Employment Opportunity Commitment
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.
Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
EOE including disability/veteran