Quality and Regulatory Director

hace 5 días

Valencia, Valencia, España ARTO A tiempo completo

Job Title:
Quality and Regulatory Director

Location:
Paterna, Spain

Reports to:
Chief Operating Officer (COO)

Department:
Quality / Senior Leadership Team

Position Overview:

We are seeking a highly experienced
Quality and Regulatory Director
to lead our Quality Control, Quality Assurance, and Regulatory Affairs functions. As a senior leader, you will shape and execute the company's quality and regulatory strategy, ensuring operations and products meet all GxP standards and regulatory requirements. You will be instrumental in preparing for FDA inspections, including a
Pre-Approval Inspection (PAI) in 2026
, and in implementing and maintaining eQMS and LIMS systems in full compliance with regulatory standards.

Key Responsibilities:

  • Lead regulatory strategies to ensure compliance with FDA, EMA, ISO, and ICH guidelines.
  • Act as a subject matter expert for regulatory affairs, including approvals for API, drug products, and novel excipients.
  • Prepare the organization for FDA PAI inspections and act as Qualified Person for batch certification and release.
  • Lead implementation, validation, and oversight of eQMS and LIMS systems.
  • Drive internal audits, gap assessments, and CAPA processes, ensuring inspection readiness.
  • Oversee Quality Control and Quality Assurance teams, ensuring products meet all quality standards.
  • Prepare and submit regulatory filings (INDs, NDAs, BLAs, CTDs, DMFs) and interpret regulatory feedback.
  • Collaborate with cross-functional teams to ensure regulatory compliance throughout product development.
  • Lead, mentor, and develop Quality and Regulatory teams, fostering high performance and professional growth.
  • Build and maintain strong relationships with customers and regulatory agencies.
  • Establish risk management strategies related to regulatory and quality compliance.
  • Drive operational excellence, process improvements, and efficiency in regulatory operations.

Qualifications & Experience:

  • Bachelor's degree in Pharmaceutical Sciences, Regulatory Affairs, Life Sciences, or related field; Master's or MBA preferred.
  • Minimum 7 years of experience in quality and regulatory affairs within the pharmaceutical or CDMO sector.
  • Proven track record of leading regulatory approvals for API, drug products, and novel excipients.
  • Strong expertise in FDA/EMA regulations, GxP standards, and eQMS/LIMS implementation and validation.
  • Experience preparing for FDA inspections, particularly Pre-Approval Inspections (PAI).
  • Extensive experience in regulatory submissions (INDs, NDAs, CTDs, DMFs, BLAs) for chemical and biologic products.
  • Demonstrated leadership in cross-functional teams, with the ability to recruit, motivate, and develop high-performing teams.
  • Strong stakeholder management and relationship-building skills with regulatory agencies and customers.
  • Fluent in English; Spanish working proficiency preferred.
  • Excellent problem-solving, analytical, organizational, and strategic thinking skills.

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