Director, Quality

Director, Quality

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 worldfrom 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.

Purpose of Job :

The site Quality leader has direct responsibility for the site Quality system and leadership of the site Quality organization. He / She will ensure that a site Quality Management System is established, implemented and maintained for product manufacturing, control, storage, and primary distribution processes in accordance with applicable US Federal Regulations, ISO 13485 standards and Bausch & Lomb Global Quality requirements. He / She is a member of the site leadership team and, in partnership with the site operations leader, will sponsor a Quality and Compliance-focused culture which embraces Right First Time and Continuous Improvement expectations. Directs all technical and GMP aspects of plant activities. Interfaces with other top management personnel to set policy and to assure adherence to these, in addition to governmental standards. Responsible for the decision on acceptability and release of all Greenville products.

Key Activities :

Establishes and maintains a site Quality system, which allows for the timely supply of goods and which meets Bausch & Lomb and legal requirements, that is compliant with the B+L Quality Policy.

Areas of focus include but are not limited to : Laboratory operations (chemistry and microbiology), Lot release, CAPA system, Deviation Management system, GMP documentation, Complaint Investigation, Change Management, Supplier audit system, implementation of Global Quality systems and requirements, GMP, aseptic processing of sterile products, and ISO 13485 training. Includes establishing and maintaining an overall site Quality plan, the design and tracking of Quality metrics, and providing reports to Global Quality management.

Leads and oversees all Quality and Compliance functions for the Greenville manufacturing site, including preparation and maintenance of the site Quality budget and development of Quality personnel.

Implement and maintain policies and procedures for both internal and contract manufacturing processes. Review and approve site Standard Operating Procedures, ensuring their conformance with the applicable global device and drug regulations, ISO standards, and Bausch + Lomb requirements.

As a member of the site leadership team, is the on-site expert on Quality and Compliance, and will provide input and support for the Global Quality Strategies. Appointed as Management Representative and PRRC (as delegated) for the site.

Will establish and maintain effective cross-functional relationships with other support functions, as required : site Operations leadership, site engineering, EH&S. Includes effective relationships with global functions : Global Operations and Engineering, Global Regulatory, R&D Leadership.

Qualifications :

Computer literate, with general office software and internet use.

Education : At a minimum, a bachelor's degree in biology, microbiology, chemistry, chemical engineering, or related scientific field. An advanced degree in a science-related field or management and / or experience in multi-facility management is desirable.

Experience : A minimum of 10 years' experience in Quality Assurance, Quality systems, Quality management, or Regulatory management experience in the pharmaceutical or device industries. Demonstrated capability and experience for US Class II / Class III medical devices, as well as non-US medical device regulations, applicable sterile drug / aseptic processing regulations experience in the pharmaceutical industry. Five+ years QA experience in a high-volume manufacturing facility, including successful interactions with regulatory agencies. Five+ years in management, with a proven track record of successful people management and development of personnel.

Special Skills : In-depth knowledge of applicable regulations and standards, both domestic and international (medical device or drug). Proven technical and problem-solving skills and communication skills (verbal and written). Must have excellent organization and time management skills. Must have demonstrated highly developed skills in leadership, negotiation, and influence in order to successfully interface with individuals from scientific, production, regulatory, and executive management backgrounds, to achieve Quality, Compliance, and business goals / objectives. Must have a thorough understanding of physical investigation techniques, root cause analysis, and statistical methods.

This position may be available in the following location(s) : US - Greenville, SC (Plant)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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