Clinical QA Compliance Manager

1 week ago

Bengaluru, Karnataka, India Alcon Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Supports Clinical Development, Clinical Operations, Clinical Evaluations, Medical

Affairs and Medical Safety including Post Market Surveillance activities for all Alcon

franchises, to maximize standardization and compliance.

  • Informs senior management of the need for corrective and preventive actions with a

key advisory role in the development of action plans and monitoring of effectiveness of

action plans as a result of internal GXP audits and those submitted to Health

Authorities as a result of inspections.

  • Ensures senior management awareness of compliance issues impacting

regulatory acceptability, by appropriately escalating as per quality risk

management. Provides support to relevant functions on proper identification and

escalation 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 associated

departments such as Global Vigilance, Complaint Intake, Regulatory Affairs, Vendor

Management, etc. Trends, interprets, and presents compliance data (e.g., deviations or

deficiency letters for all franchises) according to worldwide regulatory requirements and

specifically EUMDR and Alcon standards

  • Authors or reviews & approves documentation including but not limited to:

Reviewing, commenting and/or approving documents associated with regulatory

submissions, 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 as

interpretation 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 Clinical

Development.

  • Provides support for audit & inspection preparation, conduct and remediation as

needed, for both national and local inspections (e.g., FDA, MEA, MHRA, Notified Body

etc.). Provides QA support to Supplier Evaluation Teams as needed and conducts GXP

audits as assigned.

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