Associate Director, MFG Training, Compliance and OpEx (Biotech)

Location: Hybrid role supporting facilities in Northbridge and Watertown, United States; three days in-office required, with additional site attendance during critical milestones. Travel to external partner locations is approximately 5–10%.

Salary: $150,380–$190,207 USD per year.

Company

hirify.global develops and commercializes innovative ophthalmology therapeutics focused on preventing blindness and treating serious retinal diseases.

What you will do

• Lead the design, implementation, and continuous improvement of manufacturing training programs, onboarding, refresher courses, and qualification tracking through the electronic Learning Management System.
• Support inspection readiness and serve as a subject matter expert during internal and external regulatory inspections, including pre-approval inspections.
• Lead manufacturing deviation investigations, CAPAs, change-control risk analysis, complaint and failure investigations, FMEA, and HACCP assessments.
• Oversee SOP and batch-record creation, review, and optimization to close compliance gaps.
• Develop a site-wide continuous improvement culture using Lean, 5S, Kaizen, Value Stream Mapping, and Six Sigma methods.
• Mentor and manage training, compliance, and continuous improvement personnel while aligning goals across manufacturing sites and functions.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Business Operations, or a related technical field.
• Minimum 10 years of related experience in the pharmaceutical, biotechnology, or medical device industry, including at least 5 years in a leadership or supervisory role.
• Experience with inspection readiness initiatives and pre-approval inspection activities.
• Demonstrated ability to lead cross-functional teams, influence stakeholders without direct authority, and translate regulatory requirements and data into manufacturing workflows.
• Proven experience resolving operational and compliance root causes, managing multiple priorities, and communicating with executive leadership.
• Demonstrated management experience covering talent assessment, recruitment, retention, and employee development.

Nice to have

• Six Sigma Green Belt or Black Belt certification.
• Lean Master, PMP, master’s degree, or MBA.

Culture & Benefits

• Hybrid work schedule with multi-site manufacturing support.
• Work focused on patient safety, regulatory compliance, product integrity, and reliable production.
• Culture emphasizing transformational innovation, integrity, compassionate excellence, and inclusive collaboration.
• Opportunity to improve manufacturing efficiency, reduce waste, and support innovative ophthalmology therapies.