MES Delivery Lead

Hw3 Llc; Huntsville (AL); On-site; USD 140,000 - 180,000; Full time

Job summary

Hw3 Llc in Huntsville, AL seeks an experienced Senior Program Manager to lead greenfield pharmaceutical manufacturing site initiatives, guiding design, execution and delivery across multiple workstreams.

You will apply Agile and Waterfall methods, ensure GMP/GxP compliance, manage senior stakeholders and partner with Manufacturing, Quality, IT, and Operations to translate business needs into effective digital solutions.

Qualifications

• Bachelor's degree in IT, CS, PM or related field.
• 10+ years of program, portfolio or complex project management experience.
• Proven experience managing large-scale, cross-functional programs with multiple workstreams.
• Strong understanding of Agile, Waterfall, Scrum and software development methodologies.
• Experience within pharmaceutical manufacturing and GMP environments.
• Strong analytical, problem-solving, risk management and decision-making skills.
• Excellent communication and stakeholder management with ability to influence senior leadership.

Responsibilities

• Lead large-scale, cross-functional programs through design, execution and delivery for a greenfield pharmaceutical manufacturing site.
• Manage multiple projects and workstreams, ensuring delivery against timelines, budgets, resources and business objectives.
• Apply Agile, Waterfall and other project management methodologies as appropriate.
• Coordinate delivery teams and oversee release planning to ensure effective and timely implementation of solutions.
• Ensure programs and solutions comply with GxP, GMP and relevant regulatory requirements.
• Partner with Manufacturing, Process Engineering, Quality, Operations, IT and Technical Services/Manufacturing Science teams to understand business processes and resolve issues.
• Drive adoption and implementation of new technology and digital solutions in alignment with site and IT strategy.
• Manage senior stakeholders, providing clear communication, progress updates and reporting on program performance.
• Identify and manage program risks, dependencies and trade-offs, developing appropriate mitigation strategies.
• Lead and influence cross-functional teams, including stakeholders at senior leadership level.
• Evaluate emerging technologies and identify opportunities to improve business processes and site capabilities.
• Develop a strong understanding of manufacturing, laboratory and engineering processes and translate business requirements into effective solutions.

Skills

Agile methodologies

Stakeholder management

Cross-functional collaboration

Risk management

Release planning

Leadership

Education

Bachelor's degree in IT/CS/PM or related field

Job description

• Lead large-scale, cross-functional programs through design, execution and delivery for a greenfield pharmaceutical manufacturing site.
• Manage multiple projects and workstreams, ensuring delivery against timelines, budgets, resources and business objectives.
• Apply Agile, Waterfall and other project management methodologies as appropriate.
• Coordinate delivery teams and oversee release planning to ensure effective and timely implementation of solutions.
• Ensure programs and solutions comply with GxP, GMP and relevant regulatory requirements.
• Partner with Manufacturing, Process Engineering, Quality, Operations, IT and Technical Services/Manufacturing Science teams to understand business processes and resolve issues.
• Drive adoption and implementation of new technology and digital solutions in alignment with site and IT strategy.
• Manage senior stakeholders, providing clear communication, progress updates and reporting on program performance.
• Identify and manage program risks, dependencies and trade-offs, developing appropriate mitigation strategies.
• Lead and influence cross-functional teams, including stakeholders at senior leadership level.
• Evaluate emerging technologies and identify opportunities to improve business processes and site capabilities.
• Develop a strong understanding of manufacturing, laboratory and engineering processes and translate business requirements into effective solutions.

Requirements

• Bachelor's degree in IT, Computer Science, Project Management or a related field.
• 10+ years of experience in program, portfolio or complex project management.
• Proven experience managing large-scale, cross-functional programs with multiple workstreams.
• Strong understanding of Agile, Waterfall, Scrum and software development methodologies.
• Experience within pharmaceutical manufacturing and GMP-regulated environments.
• Strong analytical, problem-solving, risk management and decision-making skills.
• Excellent communication and stakeholder management skills, with the ability to influence senior leadership.

Preferred Experience

• Experience delivering programs within the pharmaceutical industry.
• Experience supporting the startup, commissioning or operational readiness of a new/greenfield manufacturing facility.
• Experience working across Manufacturing, Quality, Engineering, IT and Technical Operations.
• Experience implementing digital, technology or business process solutions within a GMP environment.
• Proven leadership of complex, cross-functional teams.
• Exposure to industry standards, forums or professional organizations.