Associate Director Quality Assurance, Technology and Innovation, System & Standards

Job Description Summary

Job Description

The Associate Director leads the overall Quality Assurance activities for all NPS Patient Support programs in designing and monitoring Quality management systems that will optimize quality performance including HUB, field, Adherence, Copay, Order Management and Specialty Pharmacy programs in integrating innovative technologies.

Your responsibilities will include, but are not limited to:

• Proactively ensure the technology innovations adhere to the Quality principles, policies and procedures that foster a knowledgeable and compliant organization are engrained in routine activities of the NPS organization.
• Work with NPS Patient Support Program vendors and internal partners to develop/enhance and maintain Quality Assurance systems/processes, which include but are not limited to incident management and routine interaction monitoring to ensure meeting regulatory standards.
• Lead Quality/Compliance activities for new technology launches to ensure all content is compliant with regulatory guidelines and NPS policies.
• Liaise with Patient Safety, Country Quality, Patient Oriented Programs (POP) owners, Legal, Privacy and Compliance for Technology platforms
• Responsible for identifying and reporting adverse events via the established Novartis systems as per applicable processes.
• Review contractual documents to provide Quality/Compliance oversight and ensure quality programs are quantifiable with success metrics
• Identify, develop, and implement training that addresses Quality and Compliance policies and functional requirements for related roles within each NPS function.
• Continuously evaluate, to identify opportunities and risks in area of Quality/Compliance systems and standards including remedial action plans and tracks resolution.

Required Qualifications:

• Professional experience within the Pharmaceutical industry (10 years min.)
• Minimum 7 years of experience within the regulated pharma environment and knowledge of related regulations
• Experience in QA processes, including test planning, test case development, test execution, and defect tracking. Familiarity with automated testing tools and frameworks.
• Ability to identify opportunities for continued improvements and drive their implementations.
• Knowledgeable on effective Quality Systems & Standards and experienced in audit related activities both internally and externally
• Strong communication & negotiation skills
• Experience in project management, planning and organization, preferably those involving AI or computerized systems and ability to work effectively as an individual contributor and in a team structure; maintain strong cross-functional ties with key business partners.

Education:

• BA /BS required.

Novartis Compensation and Benefit Summary:

The pay range for this position at commencement of employment is expected to be between $132,300.00 and $245,700.00 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired