Summary of the position:
Alcon is seeking a highly skilled and versatile Lab Lead/Manager to join our team. The ideal candidate will have a strong background in lab management, regulatory compliance and will also be adept at managing Project Management Office (PMO) responsibilities. This role is crucial for ensuring our lab operations run smoothly, comply with all relevant regulations, and projects are executed efficiently and effectively.
Key Responsibilities:
Lab Management:
Oversee daily lab operations, ensuring all activities are conducted in compliance with regulatory standards.
Maintain and calibrate lab equipment, ensuring all instruments are in proper working condition.
Develop and implement standard operating procedures (SOPs) for lab activities.
Manage lab inventory, including ordering supplies and maintaining stock levels.
Ensure proper waste disposal and manage hazardous materials according to safety guidelines.
Conduct regular lab inspections and audits to ensure compliance with safety and regulatory standards.
Maintain accurate and up-to-date records of lab activities, equipment maintenance, and safety inspections.
Facilitate the implementation of new technologies and methods in the lab.
Collaborate with research and development teams to support ongoing projects and experiments.
Address and resolve any operational issues promptly to minimize disruption to lab activities.
Develop and manage the lab’s budget, ensuring cost-effective use of resources.
Regulatory Compliance:
Ensure compliance with all applicable regulatory requirements (e.g., FDA, EPA, OSHA).
Prepare and maintain documentation required for regulatory submissions and audits.
Prepare and ensure end-to-end process to secure ISO 13485 certification for the facility.
Maintain Quality Management System (QMS) covering all necessary GxP, Quality regulations, and standards.
Ensure deployment of the Alcon Quality Manual, Procedures, and Standards.
Enforcement of QMS for the department and GxP suppliers, if any.
Provide ISO 13485 training to all associates.
Prepare/maintain SOPs and GxP-trainings and implement through documented training/training administrator for VEEVA.
Prepare, conduct, and report internal/external Quality System audits.
Collect, collate, and submit documents for securing necessary licenses/approval from relevant authorities for the R&D function (e.g., test licenses).
Ensure that products (medical devices) are received, stored, handled, and transported according to label, regulatory, and GxP requirements.
Manage local deviations and Change Control.
Act as records administrator for India AGS R&D.
Coordinate with relevant local, regional, and global stakeholders.
Keep updated on the latest regulations and quality requirements.
Assess quality trends and drive continuous improvement for processes.
Project Management (PMO):
Plan, execute, and oversee projects within the lab, ensuring they are completed on time and within budget.
Coordinate with cross-functional teams to ensure project objectives are met.
Develop project plans, timelines, and budgets.
Monitor project progress and provide regular updates to stakeholders.
Identify and mitigate potential risks to project success.
Qualifications:
Bachelor’s degree in a relevant field (e.g., Chemistry, Biology, Laboratory Technology).
Proven experience in lab management, regulatory compliance, and project management.
Strong knowledge of regulatory standards and requirements.
Excellent organizational and multitasking skills.
Strong leadership and communication skills.
Proficiency in project management tools and software.
Preferred Qualifications:
Advanced degree (Master’s or Ph.D.) in a related field.
Certification in project management (e.g., PMP).
Previous experience in a regulated industry (e.g., pharmaceuticals, environmental testing).
Work hours: 1 PM to 10 PM IST
Relocation assistance: Yes
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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.