Associate Director, Manufacturing Operations

About the role

The Associate Director, Manufacturing is responsible for the leadership, strategic planning, and operational execution of manufacturing activities supporting the production of GMP-regulated combination products. This role supports manufacturing personnel, production scheduling, resource planning, process performance, and compliance activities to ensure the safe, efficient, and compliant manufacture of commercial and clinical products. The Associate Director serves as a key member of the Operations leadership team and partners closely with Quality, Engineering, Supply Chain, Regulatory, and Product Development functions to drive operational excellence, maintain inspection readiness, and support company growth objectives. This position reports to the Sr. Director, Manufacturing & Technical Operations and is onsite at our Northbridge, MA facility.

Responsibilities

• Lead all day-to-day manufacturing operations to ensure product quality, compliance, on-time delivery, and operational efficiency.
• Develop and execute manufacturing strategies aligned with company objectives, production forecasts, and business goals.
• Manage and develop a team of managers, senior manufacturing associates, and manufacturing personnel across multiple shifts.
• Establish departmental goals, objectives, staffing plans, and performance metrics.
• Drive a culture of quality, safety, accountability, and continuous improvement throughout Manufacturing Operations.
• Ensure manufacturing activities are conducted in accordance with cGMP requirements, approved procedures, quality systems, and regulatory expectations.
• Partner with Supply Chain and Planning functions to ensure production schedules, material availability, and capacity requirements are achieved.
• Monitor manufacturing performance metrics and implement improvements to increase throughput, efficiency, quality, and cost effectiveness.
• Oversee manufacturing investigations, deviations, nonconformances, and CAPA activities to ensure timely and effective resolution.
• Provide leadership and support for regulatory inspections, customer audits, and internal audits.
• Collaborate with Quality Assurance to maintain inspection readiness and support ongoing compliance initiatives.
• Lead manufacturing readiness activities for new product introductions, process transfers, scale-up efforts, and commercialization projects.
• Support process validation, equipment qualification, facility expansion, and technology transfer initiatives.
• Develop and manage departmental budgets, capital expenditures, and operating expenses.
• Partner with Engineering functions to identify and implement equipment, automation, and process improvements.
• Assess manufacturing capacity and develop workforce and infrastructure strategies to support business growth.
• Review and approve manufacturing procedures, training programs, and production documentation as appropriate.
• Establish succession planning and talent development strategies for manufacturing personnel.
• Provide leadership for cross-functional initiatives and operational excellence programs.
• Ensure compliance with company safety programs, environmental requirements, and workplace health standards.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, Operations Management, or a related technical discipline required. Advanced degree (MBA, MS, or similar) preferred.
• 8–12 years of experience in GMP-regulated manufacturing environments.
• Minimum of 3–5 years of progressive manufacturing leadership experience.
• Experience in combination products, medical devices, pharmaceuticals, biotechnology, or other regulated industries required.
• Demonstrated experience leading manufacturing teams through commercial production, scale-up activities, inspections, and operational improvements.
• Experience supporting regulatory inspections and quality system compliance activities preferred.

Skills

• Advanced knowledge of cGMP regulations, FDA requirements, and quality system principles.
• Strong understanding of combination product manufacturing operations.
• Demonstrated expertise in manufacturing planning, scheduling, and capacity management.
• Proven leadership and people management skills.
• Strong understanding of lean manufacturing, continuous improvement, and operational excellence methodologies.
• Experience leading investigations, CAPAs, and quality system activities.
• Knowledge of manufacturing validation, equipment qualification, and technology transfer processes.
• Budget management experience.
• Excellent organizational, analytical, and decision-making skills.
• Ability to effectively influence cross-functional teams and stakeholders.
• Outstanding written and verbal communication skills.
• Proficiency with electronic quality systems and manufacturing reporting tools.

Pay

$150,000 USD - $190,207 USD