Senior Specialist, Operations (Project Management)

Location: Durham, North Carolina, United States; onsite, with periodic off-shift or weekend support and up to 10% travel.

Salary: $96,200–$151,400 per year, plus potential annual bonus and long-term incentive.

Company

hirify.global develops and manufactures pharmaceutical products through local sites and a global manufacturing network focused on safe, compliant, high-quality delivery.

What you will do

• Lead complex, high-visibility initiatives for the Durham manufacturing site and advise functional leaders on execution risks, governance, reporting, and decisions.
• Coordinate Pre-Approval Inspection and filing-readiness plans, trackers, reviews, evidence, documentation, and mitigation actions.
• Manage the functional project portfolio, including intake, prioritization, sequencing, resource needs, dependencies, risks, dashboards, and project controls.
• Lead the Change Review Board operating rhythm and coordinate cross-functional assessments of quality, regulatory, technical, operational, validation, supply, schedule, and resource impacts.
• Author and coordinate incident and deviation records, supporting event narratives, impact assessments, root-cause analysis, CAPAs, approvals, and cGMP-compliant documentation.
• Develop integrated schedules, monitor critical paths and dependencies, report exceptions, and support continuous improvement, site tier processes, and gemba walks.

Requirements

• Bachelor’s degree in Engineering, Science, Business, Project Management, or a related field.
• At least five years of relevant experience in manufacturing, operations, quality, engineering, project management, or a related regulated environment, or three years with a master’s degree.
• Experience coordinating cross-functional projects, workstreams, or governance processes.
• Strong written and verbal communication skills, including clear technical or business documentation.
• Experience maintaining project plans, schedules, action logs, risk registers, dashboards, or portfolio reports.
• Ability to work independently, manage competing priorities, and escalate issues with clear recommendations.
• Ability to facilitate cross-functional work, influence without direct authority, coach project leads, manage risks and dependencies, and work effectively in a matrixed environment.
• High attention to detail, strategic thinking, adaptability, and commitment to data integrity.

Nice to have

• Experience with PAI, inspection readiness, regulatory filings, licensure, commercialization, or manufacturing start-up activities.
• Experience leading or supporting change control or Change Review Board processes.
• Experience authoring or supporting deviations, incidents, investigations, root-cause analyses, and CAPAs.
• Experience with Microsoft Project or equivalent scheduling and portfolio tools.
• Knowledge of cGMP requirements and experience in vaccine, biologics, pharmaceutical, or other regulated manufacturing environments.
• Familiarity with RCA, FMEA, Lean, or Six Sigma methodologies.
• PMP, Lean Six Sigma, or comparable training and certification.

Culture & Benefits

• Safety First, Quality Always, and Inclusion for All guide manufacturing operations.
• Benefits include medical, dental, vision, insurance, retirement benefits including 401(k), paid holidays, vacation, compassionate leave, and sick days.
• Regular first-shift schedule; off-shift or weekend support may be required for business needs, inspection readiness, incident response, or project milestones.
• Domestic relocation is listed; visa sponsorship is not available.

Hiring process

• Applications are accepted through the hirify.global careers site; the posting is effective until the day before the listed November 18, 2026 end date.
• Accommodation support is available for U.S. and Puerto Rico residents during the hiring process.