Alcon
eye care
QualityAssuranceManager
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“Quality Assurance Manager at Alcon. Skills: Quality Assurance, Regulatory Compliance, Operations Management. Build and lead the Quality function. Ensure full compliance with global and local regulatory requirements”
What You'll Achieve.
ensure full compliance with global and local regulatory requirements; ensure operational excellence; ensure timely closure of audit findings; implement robust CAPA
Industry & Context.
management of non‑conformances and CAPAs; timely closure of audit findings; robust CAPA implementation
Saudi nationals only, Saudi Nationality required, English CV is required
What They're Looking For.
Must Have
Bachelor’s degree in a Scientific or Engineering discipline, At least 5 years of Quality experience in the medical device or pharmaceutical industry, Experience with vigilance/technovigilance processes and strict reporting requirements, Fluency in English
Nice to Have
capability working with digital SAP experience is an advantage, People management experience is an advantage, Familiarity with Saudi regulatory requirements is highly preferred
What You'll Do.
Build and lead the Quality function
Ensure full compliance with global and local regulatory requirements
Establish the Quality System
Partner closely with leadership
Ensure operational excellence
Collaborate with cross‑functional teams
Embed a Quality Culture
Ensure compliance with ISO 13485
Ensure compliance with GDP
Ensure compliance with EU‑MDR
Ensure compliance with Saudi regulatory requirements
Act as the Quality Management Representative
Act as the Responsible Person for wholesale distribution
Ensure adherence to local and international standards
Lead quality operations
Review batch documentation
Oversee product release
Oversee storage and distribution
Manage non‑conformances
Prepare for external inspections
Manage external inspections
Ensure timely closure of audit findings
Implement robust CAPA
Drive vigilance activities
Drive technovigilance activities
Ensure accurate reporting to local authorities
Ensure timely reporting to local authorities
Act as the affiliate representative
How You'll Work.
Team & Collaboration
Collaborating with cross‑functional teams and leadership; Partnering closely with leadership; Work with product team
Communication Scope
communication skills to operate in an international environment
Process & Methodology
CAPA implementation
Full Job Description
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. We foster an inclusive culture and are looking for diverse, talented people to join Alcon. As a Quality Assurance Manager supporting Saudi Arabia, you will be trusted to build and lead the Quality function from the ground up, ensuring full compliance with global and local regulatory requirements while supporting one of the fastest‑growing markets in the Middle East. You will play a pivotal role in establishing the Quality System, shaping the local team, and partnering closely with leadership to ensure operational excellence. _**Please note that for this role Saudi Nationality and English CV is required.**_ A typical day in this role will include: * Collaborating with cross‑functional teams and leadership to embed a strong Quality Culture and ensure compliance with ISO 13485, GDP, EU‑MDR (where applicable), and Saudi regulatory requirements. * Acting as the Quality Management Representative and, where required, the Responsible Person for wholesale distribution, ensuring adherence to local and international standards. * Leading quality operations including batch documentation review, product release, storage and distribution oversight, supplier qualification, and management of non‑conformances and CAPAs. * Preparing for and managing external inspections by Health Authorities and Notified Bodies, ensuring timely closure of audit findings and robust CAPA implementation. * Driving vigilance and technovigilance activities, ensuring accurate and timely reporting to local authorities and acting as the affiliate representative when required. **WHAT YOU’LL BRING TO ALCON** * Bachelor’s degree in a Scientifi
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