Expert Compliance & Regulatory

ph3Aperçu /h3 h3SUMMARY /h3 pThis position is responsible for carrying out the QA Regulatory and Compliance activities of our manufacturing site in Yverdon-les-Bains (BioPlant). /p pThe position leads the QA oversights of regulatory affairs-related activities, support geographic expansion initiatives and support the inspection program. /p pThis role ensures compliance with global regulatory requirements while facilitating market entry into new regions. /p h3DUTIES AND RESPONSIBILITIES /h3 h3Compliance /h3 ul liEnsure compliance with GMP and GDP regulations and guidelines (including, but not limited to, Eudralex, 21CFR, Pharmacopoeias, ICH, PIC/S). /li liEnsure compliance with country-specific regulations (including, but not limited to, Switzerland, Europe, USA, Brazil, China). /li liSupport the inspection readiness program to always ensure preparedness for Health Authorities inspections. /li liFollow the on-time remediation of inspection findings. /li liFollow the self-inspection program to ensure appropriate continuous compliance of the Quality system and its application. /li liSupport the site regulatory compliance watch process. /li liEscalate immediately to manager QA Regulatory and Compliance, QP and site management any major compliance risk. /li liSupport the regulatory and geographic expansion. /li liFollow internal Change Control with a regulatory impact. /li liCollaborate with Regulatory Affairs and partners teams to provide QA oversight on regulatory submissions and variations management. /li liSupport regulatory submissions by coordinating and performing the QA review and approving regulatory dossier sections relevant for BioPlant. /li liIdentify, escalation and lead the mitigation of risks associated with new markets from a QA perspective. /li /ul h3Other duties and responsibilities /h3 ul liCollect required data and write Annual Product Quality Review for Drug Substances campaigns manufactured at the BioPlant. /li liSupport for the internal audit / self-inspection process: maintain local documentation, ensure appropriate follow-up and reporting of performance. /li liEstablish and maintain internal audit plan including annual closeout. /li liInvolve in the Health Authorities and partners’ inspections. /li liContribute positively to the strong Quality culture of the site. /li liAct within compliance and legal requirements as well as within company guidelines. /li /ul h3REQUIREMENTS /h3 ul liEducation: Master Degree in relevant field (Pharmacy, Chemistry, Biology or Bioengineering) /li liMinimum of 5 years in a quality assurance in a biopharmaceutical manufacturing environment. /li liThorough knowledge in cGMP and global biopharmaceuticals regulatory requirements. /li liThorough knowledge in Regulatory filing processes. /li liExperience in international Health Authorities inspections. /li liMust have proficiency with electronic quality systems. /li liAbility to make pragmatic and compliant decisions. /li liAbility to review using critical thinking and attention to detail. /li liStrong result orientation and committed team member. /li liAbility to adapt quickly to new situations and changing priorities. /li liComfortable working in a dynamic environment and able to be flexible as needed. /li liExcellent written and verbal communication skills with ability to present data to senior leadership teams. /li liProficient in English and French. /li /ul pDisclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. /p /p #J-18808-Ljbffr