Director, Manufacturing and Quality

Director, Manufacturing and Quality

The Director of Manufacturing & Quality provides strategic and operational leadership across manufacturing, quality/regulatory, facilities, and warehouse operations to drive safe and efficient operations and produce high-quality products across Antylia's Diagnostic Controls manufacturing sites. The position plays a critical leadership role in driving capacity expansion, optimizing cost structure, ensuring regulatory compliance, and supporting new product commercialization.

How You Will Contribute:

• Establish and execute manufacturing strategies that support business growth, operational excellence, and customer satisfaction.
• Develop, monitor and improve KPIs related to safety, quality, productivity, cost per unit, inventory and on-time delivery
• Champion Lean methodologies (5S, visual management, standard work, Kaizen) to drive waste reduction and flow across the entire value stream.
• Develop long-range manufacturing capacity plans aligned with business forecasts.
• Identify and mitigate operational risks impacting supply continuity.
• Support inventory optimization and working capital improvement efforts.
• Own the Quality Management System (QMS); ensure effective NCR/CAR processes, internal audits, supplier quality management, and gauge/calibration programs.
• Improve first‑pass yield and reduce scrap, rework, and cost of poor quality (COPQ) through structured root‑cause analysis and CAPA.
• Build, mentor, and coach a high‑performing leadership team and Develop leadership capability through structured coaching, regular feedback, succession planning, and skill‑development pathways.
• Manage department operating budgets and capital expenditures.
• Drive productivity improvements and cost reduction initiatives.
• Evaluate manufacturing investments through ROI and strategic business assessments.
• Performs other duties as assigned.

What You'll Bring That Excites Us:

• 10+ years of progressive manufacturing leadership experience in complex or multi‑site production environment in In-Vitro Diagnostics (IVD), Clinical Diagnostics, or Biopharmaceutical manufacturing.
• Proven track record implementing Lean Manufacturing and operational excellence programs.
• Experience operating in and managing FDA, ISO 13485, GMP, and quality management systems.
• Bachelor's degree in Engineering, Biology, Biochemistry, Biotechnology, Manufacturing, Operations Management, or related field required.
• Master's degree (MBA, Engineering, Life Sciences, or Operations Management) preferred.
• Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other essential time constraints.
• Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization.
• Ability to operate in manufacturing, warehouse, office and laboratory production environments
• Strong work ethic and an ability to excel within a rapidly changing and growing organization.
• 15% travel required to include visits to Franklin, MA site.

What We Offer:

• Competitive Salary:
  Range: $160k - $180k, depending on location, experience, and qualifications.
• Annual-Incentive Plan (AIP): 20%
• Benefits coverage begins day 1, including the following:
• Medical, Dental, Vision Insurance
• Disability Insurance
• Life Insurance
• 401(k) company match
• Paid Time Off (15 days annually)
• Paid Holiday time (10 company-designated days)
• Tuition Assistance
• Additional benefits available with company package

This position has not been approved for Relocation Assistance.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.

The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all the duties and responsibilities associated with it.