Sr. Manager, Quality Assurance Compliance

Socket.dev; Sinking Spring (Berks County); On-site; USD 120,000 - 150,000; Full time

Job summary

Alcon is seeking a Sr. Manager, Quality Assurance Compliance for our onsite Sinking Spring location. You will lead audit preparations, resolve findings, and drive quality systems to ensure global regulatory compliance in a fast-paced environment.

The role requires strong leadership, project management, and deep knowledge of cGMP, ISO, and Health Authority standards. Fluency in English and relevant advanced degrees are expected.

Qualifications

• Bachelor’s Degree or equivalent in related field.
• Assoc. degree with 11+ years experience; MS with 4+ years; PhD with 3+ years.

Responsibilities

• Oversee teams managing Quality Systems and Supplier Quality to ensure cGMP and ISO compliance.
• Design and implement processes for an effective Quality System including CAPA and SOPs.
• Facilitate implementation of Quality Strategy and governance processes.
• Identify opportunities for improved process efficiencies and implement changes.
• Advise on policy, conduct training, and manage quality systems to ensure regulatory compliance.
• Make key decisions affecting team operations with leadership and project management.
• Ensure all associates adhere to GxP by following SOPs and proper documentation.
• Maintain and improve compliance with regulatory requirements and continuous improvement.

Skills

Leadership

Project management

Problem solving

Communication

English fluency

Education

Bachelor’s Degree or Equivalent

Assoc. degree with 11+ yrs.

MS degree

PhD

Job description

This is an onsite position based out of our Sinking Springs Location

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers.

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. Specifics include:

In this role, a typical day will include:

• 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
  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.

Key Requirements/Minimum Qualifications:

• 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

Preferred Qualifications:

How to Thrive at Alcon:

• 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.
• Alcon provides robust benefits package including health, life, retirement, flexible time off for exempt associates, and much more!

Alcon Careers

See your impact at alcon.com/careers

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ALCON IS AN EQUAL OPPORTUNITY EMPLOYER AND PARTICIPATES IN E-VERIFY

Alcon takes pride in maintaining an inclusive environment that values different perspectives and our policies are non-discriminatory in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [e-mail] and let us know the nature of your request and your contact information.