Job Title: Associate Director Quality Professional
Location: Mumbai, India, 400059
Company: Teva Pharmaceuticals
Job ID: 58643
Who We Are
Teva Pharmaceuticals is on a mission to make good health more affordable and accessible. Our global workforce spans nearly 60 countries, and our diverse team is united by the goal of providing high-quality, affordable medicines. As the world’s leading manufacturer of generic medicines, we produce many products that are on the World Health Organization’s Essential Medicines List. Today, over 200 million people take one of our medicines every day, and we are continually striving to make an even greater impact.
How You’ll Spend Your Day
As an Associate Director Quality Professional, you will play a key role in supporting and improving Teva’s cGxP (Current Good Manufacturing Practice) Computerized Systems across the organization. Your key responsibilities will include:
Policy & Procedure Development:
Continuously improve TAPI’s cGxP Computerized Systems policies, standards, procedures, tools, and training to ensure alignment with global regulatory requirements and industry best practices.
Inspection Readiness:
Manage site inspection readiness for computerized systems and provide support during inspections.
Guide site IT and IT Quality Assurance teams on inspection trends, regulatory authority expectations, and best practices to address and mitigate gaps.
Training & Support:
Deliver training programs to TAPI’s Computerized Systems owners to ensure compliance and competence in system management.
Assist sites with IT-related projects and provide guidance on Computer Systems Validation (CSV), infrastructure qualification, and system lifecycle management.
Gap Assessments & Audits:
Conduct GxP computerized systems gap assessments and evaluations based on applicable regulations.
Provide QA IT reviews and approvals for all globally managed Computerized System deliverables, ensuring they meet compliance requirements.
System Business Ownership:
For some globally managed Computerized Systems, provide QA IT review and approval of deliverables. For others, represent site users as the System Business Owner, ensuring user requirements are met and compliance is maintained.
Your Experience and Qualifications
Education:
A Bachelor’s degree in Information Technology (BE / B.Tech) or a related field.
Experience:
10 to 15 years of experience in IT quality compliance, with a strong focus on GxP computerized systems and regulatory compliance.
Proven experience in managing computerized systems in a regulated environment, supporting system lifecycle management, and conducting gap assessments.
Skills & Knowledge:
Strong understanding of GxP regulations and their application to computerized systems.
Experience in managing IT projects related to computer system validation and compliance.
Familiarity with inspection processes and the ability to guide teams through regulatory audits.
Strong leadership, communication, and training skills.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. We provide equal employment opportunities without regard to age, race, gender, disability, or any other legally protected status. We are dedicated to creating a diverse and inclusive workplace, and we encourage all qualified individuals to apply. If you require accommodations during the recruitment process, please inform us so that we can provide a smooth and accessible experience.
If you have a passion for IT compliance and quality assurance and want to make an impact at a leading pharmaceutical company, apply today!
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