Associate I, Quality Operations

COMPANY OVERVIEW:
At Alcon, we are inspired by the meaningful work we do to help people see brilliantly. As the global leader in eye care, we boldly innovate, champion progress, and act with speed. We recognize and celebrate the contributions of our people, offering career opportunities that empower growth and fulfillment. Together, we go above and beyond to make a lasting impact on the lives of our patients and customers. We cultivate an inclusive culture and invite diverse, talented individuals to join us in shaping the future of eye care.

As an Associate I, Quality Operations (Supplier Quality), you will be responsible for supplier qualification and ensuring that raw materials, as well as primary and secondary packaging components, are procured from approved suppliers and meet defined specifications. You will ensure compliance with quality agreements and specifications for materials and contract services. Additionally, you will support localization projects and collaborate with internal stakeholders and external partners to resolve material-related quality issues and provide technical expertise.

In this role, a typical day will include:
Quality Compliance & Investigations
- Meet quality objectives set by management and comply with Alcon QMS and safety requirements.
- Issue quality remarks/notifications to suppliers and ensure appropriate corrective actions.
- Conduct NCI, DCT, and incoming material-related OOS investigations; identify root causes and implement CAPAs.
- Ensure timely closure of all TW records.

Supplier Documentation & Change Management
- Manage supplier quality documentation: change notices, onboarding forms, reviews, performance trending, CAPAs.
- Initiate and execute supplier-related change requests, ensuring timely completion without production disruption.
- Prepare supplier certification documents and coordinate with stakeholders for Veeva effectiveness.

SOPs & System Management
- Create, review, and approve SQA-related SOPs, forms, and QAAs; conduct periodic reviews in Veeva.
- Serve as SAP and LIMS super user; train SQA associates and CSI stakeholders.

Cross-functional Collaboration
- Coordinate with cross-functional teams to resolve material-related quality issues.
- Attend Tier 2/Tier 3 meetings and support QE projects and localization engineering runs.

Reporting & Metrics
- Develop and submit APQR sub-reports on supplier quality.
- Collate supplier quality attributes for quality council and metrics scorecards.
- Support budget preparation and monitor SQA spending vs. forecast.

Audits & Regulatory Support
- Participate in internal/external audits; prepare and submit audit documentation.
- Author audit responses and support CAPA follow-up and closure in TW ACE system.
- Conduct QRAs and gap assessments against corporate procedures.

Training & Leadership
- Provide coaching and training to the team; support competency development.
- Manage onboarding, OJTs, qualification packages, and job allocation for new associates.

Additional Responsibilities
- Review and approve packaging component specifications in ENSUR.
- Act as backup for Veeva document approvals.
- Serve as the single point of contact for supplier quality issues (24/5 availability).
- Perform other duties as assigned by the functional manager.

WHAT YOU’LL BRING TO ALCON:

- Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related discipline.
- Minimum 3-5 years of experience in supplier quality, quality assurance, or quality operations within the pharmaceutical or medical device industry.
- Solid understanding of GMP, ISO 13485, and quality system regulations.
- Hands-on experience with quality tools such as CAPA, OOS investigations, and root cause analysis.
- Proficiency in electronic quality systems such as Veeva, SAP, LIMS, and TrackWise.
- Experience in supplier qualification, onboarding, and performance monitoring.
- Strong documentation skills, including SOP creation, audit responses, and change control management.
- Ability to coordinate cross-functional teams and manage supplier-related issues effectively.
- Experience supporting internal and external audits, including audit logistics and CAPA follow-up
- High attention to detail with strong organizational, analytical, and communication skills.
- Ability to train and coach team members and stakeholders on quality systems and processes.
- Flexibility to serve as a single point of contact for supplier quality issues with 24/5 availability.
- Demonstrated ability to manage multiple priorities and deliverables in a fast-paced environment.

HOW YOU CAN THRIVE AT ALCON:
At Alcon, we are committed to fostering a work environment where our employees can grow, innovate, and excel. Here’s how you can thrive in your role with us:

- Career Growth & Development - Gain access to continuous learning opportunities, leadership training, and career advancement programs to support your professional journey.
- Collaborative Culture - Work alongside