Director, Quality Assurance Compliance

Alcon Research•Houston, TX

1d•Onsite

About The Position

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 Director, Quality Assurance Compliance (Management Path) is primarily responsible for leading Quality Systems, Complaints, and Supplier Quality Management processes at the Houston Manufacturing Site, ensuring compliance with current Good Manufacturing Practices (cGMP), Health Authority, Alcon Quality Manual, and International Organization for Standardization (ISO) standards. You will guide and manage teams to achieve goals.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school +18 yrs; Assoc.+14 yrs; M.S.+7 yrs; PhD+6 yrs)
The ability to fluently read, write, understand and communicate in English
10 Years of Relevant Experience
6 Years of Demonstrated Leadership

Responsibilities

Lead and direct teams, developing and implementing strategies for departmental success and alignment with company goals
Manage Quality Systems (Internal/External Audits, Document Control, Change Control, Training), Complaints, and Supplier Quality Management processes to ensure compliance with cGMP, Health Authority, and Alcon Quality Manual requirements, as well as 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 to ensure compliance with regulatory requirements
Provide oversight of Supplier Quality activities, including supplier risk assessment, supplier audits, business continuity projects, and ensuring comprehensive and timely investigation into non-conforming supplier related events
Make significant decisions within your division, approving departmental budgets and major projects.
Allocate resources to lead, plan, and execute project activities in alignment with site initiatives and budgetary requirements.
Demonstrate leadership, strategic planning, cross-functional collaboration, advanced problem-solving, and strong communication skills
Lead audit preparation activities for the site and actively participate in external audits by Notified Bodies and Health Authorities
Provide oversight for the Site Internal Audit, External Audit, and Supplier Quality programs, Escalation / Field Action Assessment / Recall, Management Review, Document Management, and periodic reporting of key facility metrics
Interact effectively with Global Compliance, Quality Systems, and External Supplier Quality groups and ensure site representation during discussions / communications about new and evolving regulatory requirements, global quality initiatives, and other quality community topics
Commit to continuous improvement and contribute to the overall compliance of the organization.
Drive continuous improvement initiatives to enhance the site quality system and product quality, ensuring compliance with governing regulations and corporate procedures
Adhere to Good Practice (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