Clinical QA Compliance Manager

Supports Clinical Development, Clinical Operations, Clinical Evaluations, Medical
Affairs and Medical Safety including Post Market Surveillance activities for all Alconfranchises, to maximize standardization and compliance. Informs senior management of the need for corrective and preventive actions with akey advisory role in the development of action plans and monitoring of effectiveness ofaction plans as a result of internal GXP audits and those submitted to HealthAuthorities as a result of inspections. Ensures senior management awareness of compliance issues impactingregulatory acceptability, by appropriately escalating as per quality riskmanagement. Provides support to relevant functions on proper identification andescalation of quality related issues.Identifies and collaborates in establishing appropriate measures to assure communication,management and remediation of compliance issues involving Clinical Development/Clinical Evaluations, Medical Safety and Medical Affairs and other associateddepartments such as Global Vigilance, Complaint Intake, Regulatory Affairs, VendorManagement, etc. Trends, interprets, and presents compliance data (e.g., deviations ordeficiency letters for all franchises) according to worldwide regulatory requirements andspecifically EUMDR and Alcon standards Authors or reviews & approves documentation including but not limited to:Reviewing, commenting and/or approving documents associated with regulatorysubmissions, notes to file, templates, template revisions, aggregate reports(CEP/CERs, PMCF, PMSP, PSURs), policies, QSPs and SOPs. Provides SME consultation and assists in education and training as well asinterpretation of global regulations and guidelines (e.g. EUMDR, FDA, GCP, GLP,GMP, MDR, ISO Stds., GMP, Vigilance, Deviation Management, etc.). Provides guidance, review, and approval of associated deviations (NCI, & CAPAs)If necessary, lead and support the investigation of deviations and other quality issues detected from any source.Accountable for CAPA follow up and verification activity jointly with ClinicalDevelopment. Provides support for audit & inspection preparation, conduct and remediation asneeded, for both national and local inspections (e.g., FDA, MEA, MHRA, Notified Bodyetc.). Provides QA support to Supplier Evaluation Teams as needed and conducts GXPaudits as assigned.

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

Alcon is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital status, disability, or any other reason.