Onsite Senior QA Compliance Manager

Alcon

Sinking Spring (Berks County)

On-site

USD 120,000 - 180,000

Full time

5 days ago
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Job summary

Alcon is seeking a Sr. Manager, Quality Assurance Compliance to lead quality programs ensuring global regulatory compliance for eye care products.

Responsibilities include managing Quality Systems, CAPA processes, and supplier qualification initiatives while guiding governance and strategic quality initiatives. The role requires strong leadership, deep knowledge of cGMP/ISO standards, and extensive experience in QA/compliance.

Qualifications

  • Fluent reading, writing, and spoken English.
  • Bachelor's degree or equivalent with related experience required.
  • Advanced degrees/years of experience per the listed combinations.
  • 7 years of relevant QA/regulatory experience or equivalent.

Responsibilities

  • Oversee Quality Systems and Supplier Quality processes ensuring cGMP, Health Authority and ISO compliance.
  • Design and implement quality system processes including self-inspections, CAPA, and SOP compliance.
  • Lead audit preparations, resolve findings, and support governance processes.
  • Identify opportunities for process improvements and drive efficiency.
  • Ensure adherence to GxP, SOPs, documentation, and training requirements.

Skills

English language

Education

Bachelor's Degree or equivalent
Assoc. +11 yrs. ; MS +4 yrs. ; PhD +3 yrs.

Job description

Alcon is seeking a Sr. Manager, Quality Assurance Compliance to lead quality programs ensuring global regulatory compliance for eye care products.

Responsibilities include managing Quality Systems, CAPA processes, and supplier qualification initiatives while guiding governance and strategic quality initiatives. The role requires strong leadership, deep knowledge of cGMP/ISO standards, and extensive experience in QA/compliance.

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