Senior Director of Quality (Biotech)

Location: York, United States; onsite leadership across cleanroom and manufacturing operations.

Company

hirify.global operates BioTechnique, a sterile injectable full-service CDMO providing formulation, compounding, fill-finish, lyophilization, and clinical logistics services from IND applications through commercial production.

What you will do

• Lead Quality Assurance, Quality Control, Compliance, and Validation across cGMP-regulated operations.
• Provide floor-level quality oversight for utilities, warehouse operations, manufacturing, packaging, batch review, product transfer, laboratories, and suppliers.
• Lead validation, change control, CAPA, deviation management, investigations, and continuous improvement initiatives.
• Prepare for and serve as subject matter expert during regulatory inspections, client audits, and pre-approval inspections.
• Manage and mentor QA/QC/Validation personnel and external consultants, including training and inspection readiness.
• Support Business Development, MSAT, product approvals, customer programs, and sponsor-facing quality strategy.

Requirements

• Bachelor’s degree or higher in life sciences, engineering, or a related technical field; an advanced degree is required.
• Minimum 15 years of pharmaceutical quality assurance experience focused on aseptic and sterile manufacturing.
• At least 5 years of leadership experience in complex matrixed organizations.
• Extensive experience with cleanroom operations, ISO standards, cGMP environments, quality assurance, regulatory compliance, and validation.
• Advanced knowledge of FDA, EMA, and international regulatory frameworks, plus experience hosting inspections and client audits.
• Strong independent judgment, cross-functional leadership, project execution, mentoring, and training skills.

Culture & Benefits

• Medical, dental, and vision coverage, with PSC paying 100% of qualifying employee medical premiums and 50% for qualifying dependents.
• 401(k) plan with matching contributions.
• PTO, sick time, and paid holidays.
• Education assistance, pet insurance, fitness perks, and financial discounts.
• Equal employment opportunity workplace with a focus on employee development and work-life balance.