Regulatory and eCompliance Lead (ASPEX)

Job Description

Manages resources including a team to develop, establish, & maintain quality compliance programs, policies, procedures, and controls to ensure that products conform to cGxPs, established standards, agency regulations, guidelines, & industry compliance trends.

Provides expertise and guidance in interpreting regulatory agency regulations, guidelines, & internal reqs to ensure site compliance.

Oversees and is directly responsible for the Risk Management program. Supports the process of developing integrated strategic and operational plans for compliance for the site.

Responsible for Field Alert Report Assessment, Field Alert submission, and notification of recall to Health Authorities.

Participates in budget and resource planning, strategic planning, and quality projects.

Establishes, and maintains Change Control System .Manages APR/PQR process.

Interfaces with Regulatory Affairs & manages the preparation, assembly & review of the Quality (CMC) Sections of global regulatory submissions.

Coordinate the responses to global regulatory agencies dealing with Quality Sections of dossiers.

Maintain high level of technical expertise concerning global regulatory requirements and technical sections of Quality (CMC) Sections of regulatory dossiers.

Lead the Site e-Compliance activities for all GxP projects: Provide quality support for all GxP projects.

Drive the site implementation of the Novartis e-Compliance strategy and one CSV process in line with the Novartis quality and regulatory requirements to ensure effective and compliant quality oversight over Novartis GxP computerized systems.

Ensure the e-Compliance strategy is fully integrated into the Site strategy.

Actively lead the e-Compliance organization for the Site. Develop and integrate appropriate risk based models for CSV activities of GxP systems.

Liaise effectively with NBS IT, all e-Compliance personnel across NVS, other Divisional quality & business functions to ensure that standards and effective processes.

Ensures quality oversight at site level for all GMP services provided by the external service provider.

Manages all quality aspects in relation to the service provider on local site level, participates in inspections and regular site service provider performance review meeting.

Assures Alcon/Novartis SOPs are followed, reviews records & signs-off records as required by SOPs. Evaluates deviations, changes and escalations as required.

Monitors service provider performance on site level.

EEO Statement

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

Minimum requirements

Bachelor's Degree or equivalent years of directly related experience

The ability to fluently read, write, understand and communicate in English

7 Years of Relevant Experience (Relevant validation, quality, regulatory and compliance experience in GMP production and/or laboratory environment; Experience interacting with Regulatory Authorities)

5 Years of Demonstrated Leadership

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