Director, Quality Compliance

Director, Quality Compliance
Date: Mar 15, 2023
Location:
West Chester, Pennsylvania, United States, 19380
Company: Teva Pharmaceuticals
Job Id: 39402
Who are we?
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.
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.
Job Description
The Director, Quality Compliance is responsible for leading investigations of Quality issues, assessment of potential serious breach, CAPAs, and where applicable, notification to management on critical events and ensure submission to applicable regulatory authorities.
Essential Responsibilities
- Support management controls by leading internal Quality Councils meeting, analyzing quality metrics, KPIs and improve knowledge management through lessons learned sessions.
- Lead inspection readiness activities with the support of the Clinical Audit team.
- Support the Clinical audit team when required in quality oversight of the clinical studies by performing audits of: clinical investigator sites, CRO and ancillary vendors (qualification and requalification), phase I facilities, internal system/process, selected clinical documents and Study TMF.
- Supervise and manage the Compliance team in alignment with GCQ SOPs, policies, initiatives and goals.
- Lead and collaborate with all functional areas to ensure global clinical trial activities are conducted in compliance with the current Good Clinical Practice (cGCP) regulations, the International Conference on Harmonization (ICH), Declaration of Helsinki, company policies and procedures and other applicable regulatory requirement(s).
- Manage product complaints associated with clinical trial supplies.
- Involve in the preparation, conduct, and responses to a Sponsor or Site where applicable, regulatory agency inspection (e.g., FDA, EMA, BfaRM, Health Canada, MHRA).
Qualifications
- Bachelor's Degree required.
- Minimum of 8 years of GCP experience required. Knowledge of cGMP and cGLP preferred.
- Auditing experience required.
- Must have a strong knowledge of global drug development and have the ability to assist other relevant departments in performing risk assessments & risk management.
- Ability to travel 25% of time required to include international travel.
Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, however, Teva will consider requests for reasonable accommodations.
Function
Quality
Sub Function
R&D Quality
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.
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.
EOE including disability/veteran