Quality Assurance Compliance Manager

Alcon Laboratories India Pvt Ltd; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Alcon Laboratories India Pvt Ltd in Bengaluru seeks a Manager I, Quality Assurance Compliance to lead quality systems, audits, and supplier quality, ensuring cGMP, Health Authority, and ISO compliance globally.

You will drive KPI reporting, training, policy guidance, and continuous improvement while maintaining rigorous documentation and SOP adherence to regulatory requirements.

Qualifications

• Experience leading quality systems teams and audits.
• Strong understanding of cGMP, Health Authority and ISO standards.
• Ability to train and advise on quality policy and regulatory compliance.
• Leadership, time management and cross-functional collaboration skills.

Responsibilities

• Lead a team managing Quality Systems, Complaints, and Supplier Quality Management to ensure compliance with cGMP, Health Authority, and ISO standards.
• Facilitate the implementation of the Quality Strategy and support governance processes.
• Identify opportunities for improved process efficiencies and implement changes.
• Advise on policy, conduct training sessions, and manage quality systems for regulatory compliance.
• Make operational decisions requiring leadership, time management, communication, and team coordination.
• Ensure adherence to GxP regulations by following SOPs, maintaining documentation, and completing required training.
• Commit to continuous improvement and regulatory compliance in operations.

Job description

Manager I, Quality Assurance Compliance (M) At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly.

The Manager I, Quality Assurance Compliance (Management Path) is primarily responsible for developing and maintaining compliance systems with current Good Manufacturing Practices (cGMP), Health Authority, Alcon Quality Manual, and International Organization for Standardization (ISO) standards. You will ensure the implementation of global quality standards, manage Quality Key Performance Indicator (KPI) reporting, audits, supplier quality, and document control, and lead change control processes.

Specifics Include:

• Lead a team managing Quality Systems, Complaints, and Supplier Quality Management to ensure compliance with cGMP, Health Authority, and ISO standards
• Facilitate the implementation of the Quality Strategy and support governance processes
• Identify opportunities for improved process efficiencies and implement changes
• Advise on policy, conduct training sessions, and manage quality systems for regulatory compliance
• Make operational decisions requiring leadership, time management, communication, and team coordination
• Ensure adherence to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, and completing all required training
• Commit to continuous improvement and regulatory compliance in operations

All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

Qualifications:

Associate shall have the appropriate education and experience to successfully perform the responsibilities/activities of this role

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.

Experience Level Mid Level