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Director, Quality System Compliance

Date: Apr 10, 2024

Location:

Parsippany, United States, New Jersey, 07054

Company: Teva Pharmaceuticals

Job Id: 55102

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 Director of Global Quality Systems Compliance plays a critical role in overseeing and continuously improving quality processes across Teva Global Operation (TGO) to advance compliance, efficiency, and customer experience.

The Director will also be responsible for:

• ensuring that our products, processes, and Quality Systems are in compliance with regulations and Teva policies.

• ensuring that Teva’s quality system (e.g. CAPA, management review, design control, non-conformances, FCAs, change control) produces products and processes that conform to defined requirements.

• participation in key global projects that provide quality acceleration, ensuring the overall strategy for advance compliance and capture changes in regulations.

• global compliance quality oversight and governance in strong collaboration with manufacturing operations to ensure excellence in inspection readiness and successful inspection management at critical internal and external supply sites.

• taking an active part in the Veeva Quality Vault project, specifically in the area of the Electronic Document Management System (EDMS).

Location:This is a hybrid position that can sit out of our Parsippany, NJ or West Chester, PA offices.

Travel: Must be able to travel based on business need; up to 40% when critically required (domestic and international)

How you’ll spend your day

• Leadership and Oversight:

• Overseeing and continuously maintaining TGO Quality Corporate Standards and Policies to advance compliance and capture changes in regulations.

• Collaborating with regional and site-specific teams to track, report, and present updates in Teva Quality System.

• Monitoring the effectiveness of the Quality system and providing reports to executive management.

• Defining vision and executing strategy for continued compliance and increased efficiency of Quality Management Systems, including improved investigations processes, CAPA effectiveness, etc.

• Overseeing and continuously leading improvement in quality processes across TGO to advance compliance, efficiency, and customer experience.

• Acting as a business leader and taking an active part in the Veeva Quality Vault project, specifically in the area of the Electronic Document Management System (EDMS). Leading Quality compliance initiatives/projects for Quality System 2.0.

• Providing standards overview and training locally based on site requests.

• Quality System Management and Oversight:

• Drafting, revising, managing distribution, archiving, and lifecycle approvals of Quality Corporate Standards and Policies, including maintenance of guidance for SmarTeam.

• Driving gap assessments - corporate standards vs new guidance, corporate standards vs Teva site BoH observations, corporate standards vs other firms’ observations.

• Continuous Improvement:

• Implementing best practices for enhanced efficiency and effectiveness.

• Tracking regulatory trends and providing guidance on expected changes affecting existing and future strategies.

• Leading Cross-Functional Collaboration such as SME’s groups for sharing best practices, new regulations updates, improvement to standards, etc.

• Quality Plan development/tracking as required.

• Tracking regulatory commitments, creating Investigator Database.

• Supporting weekly Quality Portal updating.

• Initiating and maintaining site directory for quality management to be updated monthly.

• Providing Inlet air/other engineering quality guidance

• Collaborate with Quality Assurance, Regulatory Affairs, Research and Development, and other relevant departments.

• Provide on-site support as per company needs in remediation, hands-on with Teva sites, supporting Quality Improvement Program activities , remediation efforts, and regulatory inspections both on-site and remotely.

• Business leader for Veeva project –play critical role part in the project team and support deployment in later stage of the project.

• Create and implement sustainable Quality System processes, particularly in the following areas: Corporate policies and standards as well as communication systems.

• Create and Implement quality systems that will acquire and analyze data required to manage the Management Review Process and the CAPA process

• Review division requirements and other new regulations in a timely manner, and perform and/or assist system owners by performing gap analysis and revisions to existing systems

• Provide quality / technical expertise and oversight to the activities performed within the department

• Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements

• Helpdesk site support for questions, copies, interpretation, suggestions, requests for standards.

Your experience and qualifications

Education:

• Bachelor's Degree – chemistry, microbiology, pharmacy, engineering, or related field.

• Master's Degree preferred – in science, business, healthcare, or an equivalent combination of education and experience related to Quality Assurance/Quality Control - advantage at large and complex sites.

Experience:

• Pharmaceutical Quality Manufacturing experience. Solids, Medical Device, Sterile, Biologics, and/or Biosimilars Quality Compliance experience required.

• Minimum 10 years of experience in Quality or Operations in a GMP environment. Understanding and insight into different aspects of quality functions & associated quality systems in Quality Control, Microbiology, Quality Assurance, Quality Systems, Quality Compliance, Documentation, etc. required.

• Demonstrates continuous professional development.

• Proven leadership skills, ability to lead and motivate global, cross-functional teams.

• Adequate knowledge of local current and upcoming legislation and current Quality best practices required. International experience is an advantage.

• Advanced knowledge in Problem Solving required.

• Advanced experience in working with matrix environment.

• Advanced ability to understand, interpret, and execute in accordance the Teva Quality Management System required.

• Advanced English communication skills – written and verbal required.

• Advanced teamwork skills required.

• Solid knowledge of MRP Systems and GMP impacting computer systems, like SAP, Empower, LIMS and software platforms typically used by Teva preferred.

Specialized or Technical Knowledge Licenses, Certifications needed:

• Project management certification (e.g. PMP) is a plus.

• ASQ certification can be helpful

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