Description de l'offre
Governs process change within CMO&PS through management of the relevant boards and com-mittees. Ensures that all process changes are reviewed, approved and tracked through to comple-tion, including verification of effectiveness. Responsible to ensure procedural documents are ap-propriately tracked and entered in to the Electronic Standards Operating System (ESOPs).
Manage process ownership for CMO&PS; Ensuring completeness, accuracy and appropriateness of nominations; maintaining relevant documentation and training material. Manage the Process Change Committee; Schedule the meetings, prepare the agenda, track and follow up on actions and ensure appropriate completion of effectiveness checks Manage the Procedures Review Board; Schedule the meetings, prepare the agenda and track and follow up on actions. Produce metrics to assess the quality of procedural documents being bought to the Procedures Review Board and where deficiencies are identified support with the investigation in to the root cause and initiate corrective and preventative actions (CAPAs) as appropriate. Track all CMO&PS procedural documents for full oversight and inclusion in the Pharmacovigi-lance System Masterfile (PSMF). Act as the ESOPs author for CMO&PS, creating and updating records. Prepare cross-divisional guidance documents, training material and communications on process governance standards and change management processes. Achieve efficiency gains through continuously striving to improve and simplify the processes used to maintain/update procedural documents and manage process change within CMO&PS. Act as a subject matter expert during inspections (e.g. FDA and EMA) and audits and support with post audit/inspection activities including drafting of responses to any findings and the im-plementation of CAPAs. Train and mentor CMO&PS associates on process governance standards and change manage-ment processes as well as associates from other Global Line Functions and across Novartis Divi-sions as necessary. Alert the Head Process Governance to potential compliance issues.
CMO&PS Process Governance Expert
PharmD, MSc degree in life sciences or equivalent. Fluency in English. Knowledge of other languages desirable
• Minimum 2 to 4 years of experience in the pharmaceuti-cal industry, particularly pharmacovigilance
• Excellent organizational skills
•Procedural document writing experience
• Good communication and presentation skills
• Experience of managing activities and projects in a matrix environment
•Ability to mentor and coach
Barcelona Gran Vía
Research & Development
Global Drug Development
CMO & PATIENT SAFETY GDD
Novartis Farmacéutica, S.A.