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Sr Quality Compliance Specialist

Date: Oct 13, 2021

Location: Irvine, California, US, 92618

Company: Teva Pharmaceuticals

Company Info

 

 

If you’re like people at Teva, you dare to be different. We’re 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.

 

Teva’s Irvine, CA production site is one of our complex manufacturing and supply chain operations.

 

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 on the 401(k), Employee Stock Purchase Plan and Tuition Assistance.

 

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!

 

Relocation Offered.

Job Description

 

Teva is searching for a Senior Quality Compliance Associate to join our Quality Compliance team in Irvine, CA! In this role, you will:


• Lead internal audits for the site’s compliance to GMP regulations, collaborate with departmental stakeholders to oversee that needed actions are addressed in a timely fashion.
• Manage the site’s routine gap assessment process between new/updated corporate standards and site procedures.
• Drive timely input from departmental stakeholders for conducting gap assessments and completing subsequent CAPAs to close identified gaps.
• Notify senior leadership and corporate leaders of critical compliance issues through the escalation procedure; orchestrate activities related to field alerts, market action decisions, and related corrective activities.
• Participate and take active role in regulatory inspections and communications.
• Work with subject matter experts to keep the site inspection-ready, organizing resources and materials, and provide input on correspondences with the regulatory authorities.
• Lead Supplier Quality Management and collaborate with stakeholders working to qualify new suppliers, new materials, and GMP vendors for the site.
• Lead the periodic review program of established suppliers, ensure appropriate updates per management of change process.
• Establish and renew Quality Agreements with suppliers, monitor supplier audit results/responses, and on occasion, participate in audits of suppliers.
• Manage the cross-contamination risk assessment process, evaluating the risk of change requests to the site’s product portfolio and facilities.
• Write and peer-review investigations, risk assessments, and root cause analysis related to product post-market surveillance and complaints.
• Participate in monthly and quarterly routines for the site’s compliance, including the site’s quality council, annual product reviews and related sub-reports, and various trending reports.
 

Qualifications

 


• BA degree in related science, engineering or similar required
• 8 years QA or Compliance experience in an FDA regulated environment/industry required
• 4 years working in Sterile / Aseptic operating environment is required
• 8 years of technical writing experience required
• 6 years of experience as SME on GMP compliance, data integrity, auditing, investigations, CAPAs, and change management required
 

Function

Quality

Sub Function

Quality Compliance

Reports To

In process of validation

Already Working @TEVA?

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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.

Inclusion & Diversity at Teva

 

Empowering our diverse employee base and creating an inclusive culture is both a business imperative and an opportunity to bring us closer to our patients, our partners and our communities. Teva employees respect and embrace a diverse range of experiences, capabilities and perspectives that connect us to new insights and opportunities, while building a more inclusive culture for all. We strive to enable a work environment where all employees can feel engaged and know they are making an important contribution to improving health and making people feel better.

 


Nearest Major Market: Irvine California
Nearest Secondary Market: Los Angeles