Business System Management Associate Director (GxP)

Location: Primary location in Czechia, with a hybrid working model and flexible role pattern. No relocation; no travel required.

Company

hirify.global is a global pharmaceutical company operating regulatory affairs, labeling, and digital systems programs.

What you will do

• Manage and lead Business Analysts supporting complex data analytics applications in the Global Labeling organization.
• Lead system development, maintenance, enhancements, monitoring, releases, deployment, and hypercare activities with IT Business Partners.
• Act as the liaison between Global Labeling business users and IT Partners to define requirements and align system capabilities with business needs.
• Oversee system operations and support, including issue escalation, user support cases, root-cause investigations, CAPAs, compliance risk reduction, and support-model improvements.
• Develop user-facing system resources, technical guidance, SOPs, release communications, and program updates.
• Coordinate system administration, global user forums, and cross-functional and cross-regional process alignment.

Requirements

• BS/BA in science, engineering, IT, or a related discipline.
• 10+ years of experience in Pharmaceutical Regulatory Affairs Operations, including Labeling Process and Digital Enablement experience.
• Applied knowledge of SDLC and IT or business system management, including SDLC documentation requirements for GxP/GMP applications.
• Experience supporting IT systems and business processes, preferably in Regulatory or Labeling Management, with a general understanding of the Label Update process.
• Experience with audit- and inspection-facing support for GxP systems and communicating complex concepts in high-pressure situations.
• Process-oriented experience with GxP/GMP requirements in a highly regulated industry.
• Strong leadership, problem-solving, analytical, organizational, communication, collaboration, and attention-to-detail skills.
• Ability to gather and distill relevant facts, work with cross-functional and cross-regional stakeholders, and contribute both as a team member and in a leadership capacity.
• Strong aptitude for authoring technical guidance, user guidance, SOPs, and change-control documentation.

Nice to have

• Functional working experience in system development or management within GxP-regulated areas.
• Experience with business process mapping and system design for workflow management.

Culture & Benefits

• Full-time regular employment in an international environment with global projects and professional growth opportunities.
• Hybrid work with a flexible role pattern.
• Pension and health contributions, cafeteria benefits, meal vouchers, sport, culture, health and travel options, and partner discounts.
• Five weeks of annual leave, five sick days, 15 additional paid certified sick-leave days above statutory requirements, 40 paid volunteering hours annually, and 12 weeks of parental contribution.
• Up-to-date laptop and iPhone, parking, showers, and refreshments.
• Competitive salary and incentive pay.

Hiring process

• Apply through the designated hirify.global careers application route; the posting is available until the day before 11 November 2026 unless extended.
• Search firms may not submit unsolicited candidates without a valid written agreement; no agency fee is paid without a pre-existing agreement.