Senior Expert Science & Technology (GxP & Compliance)

Job Description Summary

Leads and supports establishing and maintaining the GxP management system of the ARD Line Units at site level, serves as a contact point between local QA and the local ARD Line Units for general inquiries, represents the ARD in GxP-related committees and networks. Lead and manage all compliance/project/local network activities, support/coach team members, participate in sub-teams and contribute to overall TRD strategies and goals.

 

Job Description

Responsibilities include, but are not limited to:

• Oversee and lead all activities of assigned teams /projects to meet customer needs.
• Work according to appropriate standards for quality, ethics, health, safety, environment, protection and information security.
• Establishes and maintains GMP management system and monitors compliance with internal and external regulations. Ensures compliance to cGMP.
• Oversees all GMP activities within the Unit, Advises and supports the team heads and staff regarding GMP issues, Monitors quality exception management and drives timely completion,
• Supports training programs and implementation of SOPs, GMP, GLP, QM, HSE, ISRM and Novartis Guidelines.
• Prepares, performs, and supports GMP audits as appropriate, including organizing and tracking any follow-up action items.
• Lead initiatives to ensure continuous improvement
• Perform complex tasks without having established procedures.
• Oversee and write protocols, scientific reports, lab procedures or process related SOPs. Write scientific documents intended for external partners or for generation of registration documents.
• Communicate, address and solve problems within own and broader area of responsibility. Communicate effectively across organizational interfaces.
• Lead the transfer of know-how to other departments or external contractors, including troubleshooting and on-site training.
• Lead the optimization of project related scientific /technical activities or processes, co-ordinate local team(s) and guide development and implementation of new technologies.
• Provide scientific and technical guidance; actively foster knowledge exchange.
• Develop, mentor and coach other scientific associates, present scientific /technical results internally and contribute to publications, presentations and patents.
• Meet quality, cost and timelines in all assigned projects.

 WHAT YOU’LL BRING TO THE ROLE:

• M. Pharm/MSc with 10+ years of experience or PhD in Science (e.g. analytical/Pharmacy/Chemistry or equivalent) with 5+ years of experience.
• Recognized expertise in a GxP area with scientific as well as strategic background.
• Understanding of drug development processes and proficiency in quality principles driving drug development such as GMP and applicable regulations and policies.
• Clear understanding of current and anticipated regulatory and quality expectations.
• Broad scientific as well as strategic background Advanced coaching skills.
• Track record of innovation, creativity, problem solving and productivity.
• Successful work experience in inter-disciplinary and cross-cultural teams is preferred.
• Successful work experience in a matrix organization is preferred.
• Good oral, written (good experience in writing of scientific reports and filing documentation) and presentation skills are essential.

 

Skills Desired

Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Waterfall Model