Sr. Manager, Quality Assurance Compliance

Alcon Research•Sinking Spring, PA

3d•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 Sr. Manager, Quality Assurance Compliance is primarily responsible for developing and maintaining quality programs, systems, and procedures to ensure compliance with policies and regulations. You will lead audit preparations, resolve findings, and collaborate with auditing groups.

Requirements

Bachelor’s Degree or Equivalent years of directly related experience (or high school+15 yrs. Assoc.+11 yrs.; M.S.+4 yrs.; PhD+3 yrs.)
The ability to fluently read, write, understand, and communicate in English
7 Years of Relevant Experience

Nice To Haves

Manage your own workload and schedule while hitting your set targets.
Build positive working relationships to achieve positive goals and business objectives.
Balance experiencing new environments and working autonomously in a remote sales environment.

Responsibilities

Oversee teams managing Quality Systems and Supplier Quality processes to ensure compliance with current Good Manufacturing Practices (cGMP), Health Authority, and International Organization for Standardization (ISO) standards
Design and implement processes for an effective Quality System, including self-inspections, supplier qualifications, Corrective and Preventive Action (CAPA) processes, and SOP compliance
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 regulatory compliance
Make key decisions affecting team operations, requiring advanced leadership, project management, problem-solving, and communication skills
Ensure all associates adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, and completing required training
Contribute to the overall compliance of the organization and commit to continuous improvement