Position Details

Salary $142K – $224K USD / year

Type Full-Time

Experience lead

Exp. Years 5+ years

Education Bachelor's degree in information technology, Computer Science, Engineering, Life Sciences, or related field

Category Project & Program Management

About this role

Associate Director, Technical Project Management leads and delivers complex Pharma IT programs (GxP systems, CTMS/ELN/LIMS/MES) ensuring regulatory compliance and audit readiness, while coordinating vendor management and cross-functional teams.

Key Responsibilities

Lead portfolio of Pharma IT projects from initiation through closeout
Define and enforce project governance, SDLC and validation-related processes
Oversee requirements management, vendor selection, contract execution, and third-party validation
Provide stakeholder engagement across R&D, Clinical, Manufacturing, Regulatory Affairs, Quality, IT Security, Data Governance, and Commercial
Manage budgets, forecasting, and audit readiness

Technical Overview

Involves regulated IT project management with SDLC, validation, Agile/Waterfall hybrid methodologies, and governance to support pharmaceutical R&D, manufacturing, and clinical operations.

Ideal Candidate

The ideal candidate is a senior IT project manager with 5+ years in pharma IT, strong in GxP systems delivery (CTMS/ELN/LIMS/MES), and adept at Agile/Waterfall with hybrid governance, capable of leading audits and senior leadership communications.

Must-Have Skills

Bachelor's degree in information technologyComputer ScienceEngineeringLife Sciencesor related field5+ years of progressive IT project/program management experiencewith at least 3 years in a leadership role in pharmaceutical or life sciences ITDemonstrated experience delivering GxP-regulated systemsclinical systems (e.g.CTMSeTMF)laboratory systems (LIMSELN)manufacturing systems (MES)or enterprise data platformsExperience with both Agile and Waterfall methodologies and hybrid deliveryVendor management experience with CROssystem integratorsand SaaS providers in pharma contextsExcellent communicationsenior leadership presentationand audit readinessStrong financial acumen and experience managing project budgets and forecasting

Nice-to-Have Skills

PMPPgMPPMI-ACPGxP compliance trainingIT validation certificationsRegulatory affairs certifications

Tools & Platforms

CTMSELNLIMSMESdata platforms

Required Skills

GxPLIMSELNCTMSclinical trial systemsMESdata platformsSDLCvalidationvendor managementCROsSaaSAgileWaterfallhybrid deliveryaudit readinessregulatory complianceQA

Hard Skills

GxPLIMSELNCTMSclinical trial systemsmanufacturing execution systemsdata platformsSDLCvalidationvendor managementCROsSaaSAgileWaterfallhybrid deliveryaudit readinessregulatory complianceQuality AssuranceQA

Soft Skills

LeadershipCommunicationStakeholder relationship managementCross-functional collaborationStrategic thinkingInfluencingNegotiationProblem solving

Certifications

Preferred

PMPPgMPPMI-ACP

Industry & Role

Industry Healthcare & Medical

Job Function Regulated IT program leadership for pharma development and manufacturing

Role Subtype Clinical QA Lead

Keywords for Your Resume

Deal Breakers

Lack of 5+ years in pharma IT project management, No experience delivering GxP-regulated systems, No Agile/Waterfall experience with hybrid delivery, No vendor management experience

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