Senior Quality Assurance & Regulatory Leader (Onsite)

Socket.dev; Sinking Spring (Berks County); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Retirement plan

Flexible time off

Job summary

Alcon is hiring for a Sr. Manager, Quality Assurance to drive quality, regulatory compliance and complaint management for our products. This onsite role at the Sinking Spring location requires strategic leadership and cross-functional collaboration across QA partners globally.

You will oversee incident investigations, change controls, and continuous improvement initiatives while maintaining strict adherence to GxP and SOPs. Strong English communication and extensive QA experience are essential.

Qualifications

• Fluent reading, writing, understanding, and communicating in English.

Responsibilities

• Manage and guide teams, implementing departmental plans and ensuring team performance and success.
• Ensure products and processes meet quality standards and customer requirements. Make decisions affecting team operations and performance, requiring leadership, project management, and problem-solving.
• Foster a culture of excellence by leading performance management, talent development, and employee engagement.
• Serve as the focal point for quality-related issues, ensuring compliance with corporate standards and regulatory requirements.
• Act as an SME for product quality complaints and Health Authority responses.
• Oversee the site escalation process and promote a strong quality culture by collaborating with commercial and regional/global QA Partners on major quality events.
• Oversee multiple projects, ensuring goals are met by managing teams and cross-functional projects.
• Drive implementation of quality assurance strategies, ensuring compliance with industry standards.
• Support analytical methodology transfers, validations, and quality control analysis on finished products from all sources (R&D, Site to Site, Acquisitions).
• Oversee the site change control process ensuring all changes are properly assess for risk and have proper controls to meet process/product/regulatory requirements.
• Lead large projects and ensure continuous improvement in quality programs and processes including the digital transformation for QA.
• Lead High Risk investigations as the responsible quality intelligence engineer.
• All associates must adhere to GxP regulations by strictly following SOPs, maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training.

Skills

Leadership

English proficiency

Education

Bachelor’s Degree or Equivalent years

Assoc.+11 yrs.

M.S.+4 yrs.

PhD+3 yrs.

Job description

Alcon is hiring for a Sr. Manager, Quality Assurance to drive quality, regulatory compliance and complaint management for our products. This onsite role at the Sinking Spring location requires strategic leadership and cross-functional collaboration across QA partners globally.

You will oversee incident investigations, change controls, and continuous improvement initiatives while maintaining strict adherence to GxP and SOPs. Strong English communication and extensive QA experience are essential.