FEATURED OPPORTUNITY

Senior Director of Global Quality


 We are excited to have been retained by our client to find a culturally savvy, internationally experienced Senior Director of Global Quality to work and live in Europe! This position will have responsibility for global oversight of quality systems and programs to meet compliance, validation, and quality assurance requirements. These requirements range from non-GLP to GMP and CGP practices. This position will be based with our client’s subsidiary manufacturing office in Germany and will report to the Vice President of Regulatory Affairs and Global Quality. Our client is a clinical-stage biopharmaceutical company committed to discovering and developing novel products to prevent and treat infectious diseases.

 

Responsibilities

  • Final authority for product quality.

  • Partner with the VP of Commercial Operations to prepare the European facility for a successful vaccine launch.

  • Build and maintain robust quality program that will effectively support the various phases of drug development – preclinical, clinical, commercial launch.

  • Provide leadership and managerial oversight to the quality departments supporting operations in the US and Europe.

  • Conduct ongoing evaluations of quality programs, systems and initiatives to assure that product quality standards and regulatory compliance are achieved.

  • Interpret Regulatory Authority regulations, guidelines and policies. Utilize internal audits and quality compliance assessments programs to evaluate internal processes and procedures.

  • Assess risk and develop cost-effective strategies to ensure processes and procedures are in compliance with cGXPs.

  • Supervise and develop Quality personnel including the heads of applicable functional teams (QA Document Control, GXP Compliance, and QA Auditing).

  • Primary contact for regulatory inspections.

  • Direct the review and approval of the Quality Manual, Quality Policies, Protocols, SOPS, Batch Records, Test Methods, Raw Material Specifications, and Annual Product Reviews.

  • Direct the review and approval of Deviations Reports and Out-of-Specification Reports.

  • Ensure that manufacturing processes, equipment, facilities and systems are validated and that a robust ChangeIControl system and procedures are developed and maintained to meet state, federal, and international requirements.

  • Ensure that suppliers, contract manufacturers, and contract medical organizations are operating in compliance with state, federal, and international GXP regulations and guidelines through an external audit program.

  • Must be able to maintain a “big picture” perspective without losing site of the details necessary to meet deliverables and deadlines.

 

Requirements

  • Background in biotechnology/pharmaceuticals with experience and a successful track record in quality within FDA and/or EMEA.

  • Minimum of 15 years industry experience with 7+ years of management experience providing both strategic and leadership guidance to an organization in quality assurance.

  • Significant experience in complex dosage form technologies, including sterile products.

  • Experience in quality management and compliance systems.

  • In-depth knowledge of QA Document Control, GXP compliance, and QA Auditing. Preferred experience in GMP manufacturing.

  • Experience managing FDA/EU inspections.

  • Demonstrated leadership in cross-functional and culturally diverse team settings.

  • Excellent interpersonal skills with the ability to influence individuals and teams across the organization in the absence of a direct reporting relationship.

  • High energy, enthusiasm and excellent leadership and management skills, including excellent oral and communication skills.

 

Compensation: Competitive

 

Contact:
Amanda DeSalvatore
Project Manager
Avant Executive Solutions, LLC
 amandad@avantexec.com