Assistant Director Jobs

About The Position

Requirements

• At least a bachelor's degree in pharmacy, nursing, healthcare, another life-science or technical field, or a country-equivalent combination of education and experience.
• At least 10 years of experience in the pharmaceutical or biotechnology industry, including at least 5 years in a relevant pharmacovigilance or drug-safety field.
• Proven track record of establishing or managing pharmacovigilance quality systems, processes, and teams.
• Substantial experience preparing for, hosting, and responding to audits and regulatory inspections globally.
• Solid working knowledge of relevant pharmacovigilance regulatory requirements and guidance, including those applicable in Europe, the US, and Japan.
• Expert knowledge of GxP quality and compliance requirements, processes, and measures.
• Excellent planning and organizational skills.
• Excellent oral and written communication skills and fluency in written and spoken English.
• Ability to work in a global environment, prioritize, work independently, and take a solution-oriented approach.
• Excellent presentation skills and ability to communicate complex issues clearly.
• Demonstrated ability to author and contribute to procedural documents.
• Ability to motivate, influence, and collaborate with multidisciplinary teams.
• Professional-level computer skills, including proficiency with tracking systems and presentation software.
• Must be based in Belgium, Switzerland, or the US Eastern Time Zone.

Responsibilities

• Coordinate and manage Good Pharmacovigilance Practices (GVP) audit and inspection activities.
• Participate in the internal global GVP audit program and inspection-readiness activities in collaboration with the Quality function.
• Prepare GPS team members for inspections and ensure relevant documents and contact information are readily retrievable and up to date.
• Coordinate and prepare GPS responses to audit and inspection findings.
• Assess GPS issue-management trends and develop and implement action plans to mitigate systemic causes.
• Identify internal deviations, lead the GPS team in determining corrective and preventive actions, and guide root-cause analysis to prevent recurrence.
• Lead implementation of corrective and preventive actions in collaboration with the Quality function.
• Develop, expand, and deliver the pharmacovigilance training program, including training on procedural documents, inspection readiness, and refresher topics.
• Work with stakeholders to support or implement pharmacovigilance training across the organization; maintain, evaluate, and update GPS training curricula; and train relevant employees and third parties when applicable.
• Manage GPS procedural-document activities, including contributing to, developing, reviewing, and continually improving GPS processes and procedures.
• Participate in cross-functional procedural-document activities to determine relevance to GPS and ensure appropriate GPS input and review.
• Support document control using the Veeva system; resolve vendor questions and escalate issues to relevant GPS staff as appropriate.
• Coordinate the development and evaluation of Key Performance Indicators and adapt them to evolving business needs.
• Monitor compliance with third-party contractual obligations and PVAs, identify gaps or non-conformities, and report them appropriately to GPS staff.
• Liaise with the QA Department regarding GPS quality and compliance requirements and deliverables.
• Monitor the status of and compliance with GPS Standard Operating Procedures and other controlled documents.
• Coordinate development and compliance monitoring of PVAs, SDEAs, and other applicable agreements with business partners.
• Support, guide, and delegate GPS Quality Management activities to other GPS QM team members in collaboration with the Director, GPS Quality Management.
• Perform other tasks and duties assigned by the line manager or GPS Leadership.

Benefits

• Eligible to participate in short-term and long-term incentives programs.