Galderma Laboratories, LP
Manager, Clinical Quality Assurance (Manufacturing)
For more information, please visit www.galderma.com/us.
The Clinical Quality Assurance Manager is responsible for assuring the quality of clinical development systems, processes and related activities in the USA.
Galderma is an equal opportunity employer. M/F/D/V.
• In close collaboration with the Audit Program Manager, develop, manage and implement in North America the Innovation Quality Audit Program dedicated to clinical development activities which covers:
• Service providers (CROs, suppliers)
• Internal audits (activities, processes and systems)
• External and study specific audit plans
• Conduct audits of Investigational sites and Service Providers for qualification routine surveillance or for cause purposes as well as Internal Audits (systems, processes, tools) and independent reviews of documents.
• Act as a Clinical QA representative for the activities initiated by the three Strategic & Innovation Groups and liaise with Operational Partners to have an in depth knowledge of the clinical programs and studies, of their rationale.
• Inform, as GCP Subject Matter Expert, operational partners and Quality management of any issue adversely or potentially impacting quality, compliance or safety; recommend appropriate corrective actions,
• Participate to the preparation of trends analyses and recommend corrective actions.
• Conduct or contribute to periodic GCP Quality reviews and to the preparation of the annual Management review.
• Lead/support continuous improvement activities and conduct internal training on Quality standards and regulations.
• Perform Quality Documents Review (e. g SOPs, instructions).
• Perform internal training on Quality standards and regulations.
• Host GCP regulatory inspections in North America.
• Support the Innovation Quality Management regarding reporting tasks, definition and respect of the budget.
• Manage and develop directly reporting staff.
• Other duties as assigned.
Travel & Residency
Galderma Laboratories, L.P. USA Headquarters; Fort Worth, TX
• Seven or more years of industry (Pharmacy, Chemistry, Cosmetics, Food Processing, Medical Devices) experience and solid experience in Clinical Quality auditing.
• Experience of internal and external audits in an international environment.
• Familiar with procedures and the ability to apply/implement them correctly in appropriate circumstances.
• Demonstrated ability to analyze laws, regulations, and guidelines and apply them in practice.
• Excellent verbal and written communication skills and the ability to interact professionally with a diverse group of stakeholders, senior managers, and subject matter experts.
• Strong analytical, project management skills.
• Strong knowledge of MS Office (Excel, Power Point).
• Experience with eDocument Management, Training, CAPA's, Audit systems and tools.