Manager, Quality Assurance

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Objectives:

Manages and coordinates activities and resources  associated with  Quality Systems and Compliance, including  site regulatory compliance and inspection readiness.  Has direct oversight of the following functions:  Customer Complaints, Supplier and Incoming Quality, Training, Documentation, Annual Product Review, and Change Control.  Is a member of the Quality Assurance Leadership Team and works closely with all other quality assurance and quality control functions both on-site and above site. 

Responsibilities:

1. Manage the Quality Systems and Compliance Department and associated supervisors and staff.
2. Lead the site in compliance initiatives taking into account industry intelligence, corporate requirements, and department goals.  This includes leading the site to be inspection ready at all times.
3. Oversee customer complaint system.
4. Oversee the site training program.
5. Ensure Annual Product Reviews are completed per schedule.
6. Lead the internal audit program.
7. Oversee the Change Control program.
8. Lead the Supplier Quality system to ensure supplier excellence and maintain supply to support the business.
9. Oversee the team responsible for incoming quality inspections and release of components and raw materials.
10. Oversee the team responsible for Document Control.
11. Responsible for human and financial resources within the department, including the periodic evaluation of performance against plans and standards. 
12. Assure departmental compliance of applicable FDA, OSHA (safety), ISO, etc. regulations and support compliance awareness through tracking and communication of key metric data.

Qualifications:

• Bachelor’s Degree with a major in Engineering or Biological/Chemical Science.
• Minimum 10 years in pharmaceutical or medical device FDA GxP environment and 5+ years of supervisory experience.
• Thorough knowledge of pharmaceutical manufacturing/controls and Good Manufacturing Practices.
• Must be able to read, write, and speak English and possess basic math skills.

We offer competitive salary & excellent benefits including:

• Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date
• 401K Plan with company match and ongoing company contribution
• Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time
• Employee Stock Purchase Plan with company match
• Employee Incentive Bonus
• Tuition Reimbursement (select degrees)
• Ongoing performance feedback and annual compensation review

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch + Lomb's Job Offer Fraud Statement.

Our Benefit Programs: Employee Benefits: Bausch + Lomb

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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