Associate Director, Technical Project Management

Job Description

The Associate Director, Project Management — Pharma IT leads and delivers complex IT programs that support pharmaceutical research, development, manufacturing, and commercial operations. This role combines technical program leadership, regulatory awareness (GxP), vendor and stakeholder management, and people leadership to ensure IT initiatives are delivered on time, within scope, on budget, and compliant with applicable regulations and quality standards.

Key responsibilities

• Lead a portfolio of Pharma IT projects from initiation through closeout, including GxP systems (LIMS, ELN, clinical trial systems, manufacturing execution systems, data platforms), infrastructure, integrations, and digital transformation efforts.

• Define and enforce project governance, SDLC and validation-related processes, and reporting cadence; adapt and champion delivery methodologies (Agile, Waterfall, hybrid) appropriate to regulated environments.

• Develop comprehensive project plans, resource and capacity forecasts, risk and issue logs, dependency maps, and change-control processes aligned with quality and regulatory requirements.

• Oversee requirements management, vendor selection, contract execution, and third-party validation activities; coordinate with QA and validation teams to ensure compliance.

• Provide strong stakeholder engagement across R&D, Clinical, Manufacturing, Regulatory Affairs, Quality, IT Security, Data Governance, and Commercial functions; communicate status, risks, mitigation plans, and decision-ready options to senior leadership and steering committees.

• Manage financial aspects of projects: budget creation, tracking, variance analysis, and forecasting; ensure cost controls and value realization.

• Mentor, coach, and develop project managers and technical leads; establish clear performance expectations and career development plans.

• Lead risk management and contingency planning, including cybersecurity risk assessments and business continuity considerations for critical systems.

• Drive continuous improvement in project delivery, including lessons learned, metrics, and process optimization tied to compliance and quality outcomes.

• Facilitate regulatory readiness activities and audit support, prepare project artifacts for inspections, and ensure traceability of requirements, design, testing, and release records.

Required qualifications

• Bachelor’s degree in information technology, Computer Science, Engineering, Life Sciences, or related field.

• 5+ years of progressive IT project/program management experience, with at least 3 years in a leadership role in pharmaceutical or life sciences IT.

• Demonstrated experience delivering GxP-regulated systems, clinical systems (e.g., CTMS, eTMF), laboratory systems (LIMS, ELN), manufacturing systems (MES), or enterprise data platforms.

• Experience with both Agile and Waterfall methodologies and practical experience applying hybrid approaches in regulated projects.

• Proven vendor management experience with CROs, system integrators, and SaaS providers in pharma contexts.

• Excellent communication skills; experience presenting to senior leaders and supporting inspection/audit readiness.

• Strong financial acumen and experience managing project budgets and forecasting.

Preferred certifications

• PMP, PgMP, PMI-ACP, or equivalent project/program management certification.

• Certifications or training in GxP compliance, IT validation, or regulatory affairs are a plus.

Required Skills:

Accountability, Communication, Measurement Analysis, Portfolio, Programme, and Project Support, Program Management, Risk Management, Stakeholder Relationship Management, Team Management, Waterfall Model

Preferred Skills:

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