Associate Director, Technical Project Management Job at Merck in Rahway
Merck, Rahway, NJ, United States
Job Description
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.
Location Requirements U.S. and Puerto Rico Residents Only.
Work Arrangement Hybrid model: 3 days onsite per week (Monday–Thursday); Friday remote work unless business‑critical tasks require onsite presence.
Compensation Salary range: $142,400.00 – $224,100.00. Eligible for annual bonus and long‑term incentive, if applicable.
Benefits Medical, dental, vision, retirement, 401(k), paid holidays, vacation, and other benefits are available.
Equal Employment Opportunity Statement Merck is an Equal Employment Opportunity Employer. We provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or other legally protected characteristics.
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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.
Location Requirements U.S. and Puerto Rico Residents Only.
Work Arrangement Hybrid model: 3 days onsite per week (Monday–Thursday); Friday remote work unless business‑critical tasks require onsite presence.
Compensation Salary range: $142,400.00 – $224,100.00. Eligible for annual bonus and long‑term incentive, if applicable.
Benefits Medical, dental, vision, retirement, 401(k), paid holidays, vacation, and other benefits are available.
Equal Employment Opportunity Statement Merck is an Equal Employment Opportunity Employer. We provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or other legally protected characteristics.
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