Manager, Quality Control

Bausch & Lomb Rochester , NY 14618

Posted 3 weeks ago

Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.

Our approximately 21,000 employees are united around our mission of improving people's lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries.

Objectives:

Reporting into the Site Quality Leader, the Manager, Quality control is responsible for providing strategic and tactical leadership for the Analytical Chemistry and Microbiology departments including the laboratories to maintain a program that meets regulations and standards for raw materials and finished products. This position supervises professionals and technicians to provide continuous support of the manufacturing operation which runs 24x7 for Rochester Contact Lens Manufacturing Operation.

Responsibilities:

  • Work with Site leadership to establish, communicate and execute against strategic quality and site objectives.

  • Manage and develop the site analytical chemistry and microbiology technical staffs.

  • Ensure that the laboratories maintain compliance with cGXP, ISO, governmental regulations, B+L Directives and local procedures

  • Manage the scheduling, prioritization and execution of raw material, microbial ID, particulate matter, sterility and other testing activities. Review and release/reject analytical test data.

  • Lead environmental monitoring program in compliance with directives, microbiological control and industry standards.

  • Schedule and execute annual sterilization and solutions cleaning validations.

  • Review, revise and approve test procedures and raw material/intermediate product specifications and then communicate and implement them with the laboratories.

  • Review compendial methods and implement necessary changes in laboratories to maintain site compliance

  • Manage laboratory investigation reports, non-conformance reports, and corrective and preventative actions. Participate in and/or lead OOS and other quality investigations.

  • Provide expertise and assistance to troubleshoot and resolve plant / product issues.

  • Participate and assist in internal/external audits.

  • Provide input to and follow-up from applicable Product Quality Reviews/Quality Management Reviews and manage the performance of laboratory staff.

  • Manage technical transfer and validation of test methods.

  • Provide technical assistance and project support for production, validation and engineering departments.

  • Lead and participate in site product/process risk analyses (i.e. PFMEA)

  • Maintain and continually improve lab processes (lean lab, 6-sigma). Identify, evaluate, select and implement against continuous improvement and compliance initiatives.

  • Evaluate and upgrade lab equipment, instruments and software to support capacity requirements

  • Manage departmental compliance with safety programs and promote a culture of safety within the laboratories.

  • Promote open communications with the laboratories and internal customers.

  • Write/review/approve validation and qualification protocols.

  • Write/review/approve SOPs Develop and manage departmental budget in alignment with site operating plan.

  • Interview, hire and support qualified and diverse laboratory staff.

Qualifications:

  • Bachelor's degree in scientific or engineering discipline required, graduate degree a plus.

  • Strong analytical chemistry or microbiology lab background in a GMP environment. Experience with analytical methods and instrumentation (i.e. HPLC/UHPLC) is desired.

  • Lean/6-sigma training a plus.

  • Minimum of 5 years of experience working in cross-functional teams as a member of a fast-paced organization leading and managing people. Experience with managing and developing technical teams is required.

  • Experience in a medical device/pharmaceutical environment with knowledge of external standards and regulations is preferred.

  • Experience in high volume manufacturing is preferred.

  • Track record of implementing lean laboratory principles.

  • Excellent communication and writing skills are an essential requirement of this position.

  • Accuracy and attention to detail is required in performing all functions of this position.

This position may be available in the following location(s): US - Rochester, NY (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.

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 Health's Job Offer Fraud Statement.

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Manager, Quality Control

Bausch & Lomb