Parsippany-Troy Hills, NJ6 days ago
Your experience and qualifications** + Required – bachelor’s degree in chemistry, Biology, Pharmacy + Preferred - Master or equivalent degree in Chemistry, Biology or Pharmacy Key Requirements: + Minimum of 10 years pharmaceutical manufacturing site quality operations and leadership experience, including: + Deep knowledge of cGMP requirements of local and major international authorities like EMA and US FDA for products and process, + High level of understanding of manufacturing, packaging, technology transfer, cGMPs, EU, ICH guidelines as well as CMC content of regulatory submissions, + Deep knowledge of chemical/pharmaceutical production operations/ lifecycle, production equipment/ validation and relevant technologies and product types, + Strong understanding and experience in Data Integrity and Compliance + Experience preparing and/ or leading regulatory authority GMP + Deep knowledge of Quality Systems + Proven successful track record of leading organizational change to improve efficiency + Experience leading, inspiring and coaching large teams + Experience developing and implementing and continuously improve existing and new, efficient, and effective business processes + Must have adequate knowledge of Quality best practices + Must have adequate practical knowledge of pharmaceuticals manufacturing and/ or control + Must have adequate practical knowledge of analytical techniques and microbiological principles + Must have practical knowledge of pharmaceutical cross functional operations (e.g., Supply Chain, Engineering), product and tech transfer + Must have practical knowledge on lean manufacturing/ lean QC and OPEX tools + Good knowledge of environmental, health and safety requirements for laboratories and quality operations. Create a space where people can speak openly and are encouraged to present new ideas to improve quality + Maintain strong partnership with site leadership team + Strategic partner in the site leadership team, with Supply Chain, Project Management, R&D, MS&T and Commercial to ensure project timelines and objectives are met + Provide effective Quality leadership during internal, customer and Health Authority inspections + Ensure that Quality KPIs are meeting pre-defined targets, Ensures CAPA commitments are implemented in a timely manner and its effectiveness is monitored periodically + Plans, manages and monitors the annual Quality Operations budget and all its resources and employees.