Bausch + Lomb is solely 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.
The company is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products.
Based at our site in Berlin we are looking for an experienced Manager to act as a
EMO Quality Manager (m/f)
Key Responsibilities:
· Plans, directs, and reports on EU Pharmaceutical/Nutritional External Manufacturing to assure fulfillment of Quality system requirements (EU, FDA, ISO, Country-specific, and Bausch + Lomb
· Execute the following quality systems with respect to Pharmaceutical/Nutritional external manufacturing organizations: quality agreements, batch record review, deviation/CAPA management, validation protocol/report review, complaint investigations, change management, etc.
· Develops, implements, maintains and reportsestablished metrics to monitor external manufacture’s quality
· Assists sourcing/operations in identifying and qualifying new external manufacturing sites andrepresents Quality in new business development activities
· Develops, implements and maintains Global Quality system requirements, including B+L-specific, regulatory and ISO, for EU external manufacturers
· Establishes qualification strategy (validations, etc.) for all new or significantly changed products at external manufacturers
Requirements:
· Bachelors or Master’s degree in Chemistry, Chemical Engineering, Microbiology, or related science
· A minimum of 10 years pharmaceutical and/or Medical Device industry experience including sound experiences in external manufacturing quality management, QA/ QC, CAPA etc.
· Project leadership skills as well as GMP and Due Dilligence Auditing
· Technical knowledge of pharmaceutical / medical device quality systems
· Understanding of GMP and ISO requirements
· Ability to multi-task
· Proven oral and written communication skills in German and English
Bausch + Lomb offers a competitive salary, an international team within a renowned pharmaceutical global player and the professional advantages of an environment that supports your development and recognizes your achievement.
