Senior Manager, Investigations (Biomanufacturing)

Location: USA - OH - West Chester

Salary: $125,000.00–$181,250.00 per year

Company

hirify.global is a technology-focused biomanufacturing company building sustainable, end-to-end manufacturing solutions for medicines.

What you will do

• Lead site investigations supporting deviations and complaints, from problem definition through root cause and CAPA effectiveness checks.
• Prioritize and level-load the Investigation Team’s work, manage timelines, document progress, and escalate issues.
• Guide cross-functional partners in investigation strategy, problem statements, root cause identification, solution selection, and corrective action planning.
• Serve as the Business Process Owner for Investigations, maintaining procedures, standards, metrics, and investigation reports.
• Partner with Quality and other sites to improve investigation rigor, efficiency, risk management, and regulatory compliance.
• Coach, train, and develop direct reports while serving as the site subject-matter expert in problem-solving and root cause analysis.

Requirements

• Experience in pharmaceutical manufacturing or a similar regulated industry, including leadership or people-management experience.
• Ability to assess technical data, conduct thorough investigations, identify critical factors, and develop risk-appropriate solutions.
• Strong technical writing, verbal communication, presentation, prioritization, and follow-through skills.
• Thorough understanding of core business processes, cGMP, and regulatory requirements.
• Preferred: 10+ years of pharmaceutical manufacturing or similar regulated-industry experience with progressive management responsibility.
• Sponsorship or support for work authorization, including visas, is not available.

Nice to have

• Degree in a technical, healthcare, regulatory compliance, or related discipline.
• Multi-site or multi-function experience and cross-functional team leadership.
• LEAN manufacturing and Lean problem-solving experience.
• Project management skills and experience with Microsoft Office, SAP, LIMS, or Electronic Batch Record systems.

Culture & Benefits

• Annual cash bonus program.
• 401(k) plan with company match.
• Medical, dental, and vision coverage, plus life and disability insurance.
• Paid vacation, holidays, and other paid leave.
• Tuition reimbursement and caregiving support.