About this role
Aperçu SUMMARY This position is responsible for carrying out the QA Regulatory and Compliance activities of our manufacturing site in Yverdon-les-Bains (BioPlant). The position leads the QA oversights of regulatory affairs-related activities, support geographic expansion initiatives and support the inspection program. This role ensures compliance with global regulatory requirements while facilitating market entry into new regions.
DUTIES AND RESPONSIBILITIES Compliance Ensure compliance with GMP and GDP regulations and guidelines (including, but not limited to, Eudralex, 21CFR, Pharmacopoeias, ICH, PIC/S). Ensure compliance with country-specific regulations (including, but not limited to, Switzerland, Europe, USA, Brazil, China). Support the inspection readiness program to always ensure preparedness for Health Authorities inspections.
Follow the on-time remediation of inspection findings. Follow the self-inspection program to ensure appropriate continuous compliance of the Quality system and its application. Support the site regulatory compliance watch process.
Escalate immediately to manager QA Regulatory and Compliance, QP and site management any major compliance risk. Support the regulatory and geographic expansion. Follow internal Change Control with a regulatory impact.
Collaborate with Regulatory Affairs and partners teams to provide QA oversight on regulatory submissions and variations management. Support regulatory submissions by coordinating and performing the QA review and approving regulatory dossier sections relevant for BioPlant. Identify, escalate and lead the mitigation of risks associated with new markets from a QA perspective.
Other duties and responsibilities Collect required data and write Annual Product Quality Review for Drug Substances campaigns manufactured at the BioPlant. Support for the internal audit / self-inspection process: maintain local documentation, ensure appropriate follow-up and reporting of performance. Establish and maintain internal audit plan including annual closeout.
Involve in the Health Authorities and partners’ inspections. Contribute positively to the strong Quality culture of the site. Act within compliance and legal requirements as well as within company guidelines.
REQUIREMENTS Education: Master Degree in relevant field (Pharmacy, Chemistry, Biology or Bioengineering) Minimum of 5 years in a quality assurance in a biopharmaceutical manufacturing environment. Thorough knowledge in cGMP and global biopharmaceuticals regulatory requirements. Thorough knowledge in Regulatory filing processes.
Experience in international Health Authorities inspections. Must have proficiency with electronic quality systems. Ability to make pragmatic and compliant decisions.
Ability to review using critical thinking and attention to detail. Strong result orientation and committed team member. Ability to adapt quickly to new situations and changing priorities.
Comfortable working in a dynamic environment and able to be flexible as needed. Excellent written and verbal communication skills with ability to present data to senior leadership teams. Proficient in English and French.
Disclaimer: 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.
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