Operations Manager, Global External Operations (Biotechnology)

Location: Working from home in the United States; associated with San Rafael and Novato, California

Company

hirify.global is a global rare disease biotechnology company developing medicines for people with genetically defined conditions.

What you will do

• Manage day-to-day manufacturing operations and performance at one or more contract manufacturing organizations.
• Execute production plans for clinical and commercial products and resolve supply constraints to maintain uninterrupted supply.
• Coordinate cross-functional communication, escalation management, material movement, dashboards, and operational metrics.
• Lead operational readiness, technology transfers, new product launches, validation activities, process changes, and site exit projects.
• Perform operational gap analyses for new contract manufacturing organizations and lead mitigation plans.
• Ensure contract manufacturing organizations maintain cGMP compliance and support contracts and negotiations with procurement and external partners.

Requirements

• At least 5 years of leadership experience in operations, supply chain, or quality.
• BS or BA degree in life sciences, business, supply chain management, or a related field.
• Strong understanding of manufacturing processes and unit operations in a regulated GxP environment.
• Experience leading cross-functional, multidisciplinary teams and resolving short-term issues while supporting long-term performance.
• Strong decision-making, influencing, coaching, organizational, stakeholder management, and communication skills.
• Experience in supply planning or inventory management.

Nice to have

• Experience with CAPA, FMEA, and RCA tools in a highly regulated manufacturing environment.
• Commercial acumen and experience supporting contract manufacturing negotiations.

Culture & Benefits

• Work-from-home arrangement associated with the United States location.
• Work with global manufacturing, process development, supply chain, quality, regulatory, procurement, and external manufacturing partners.
• Contribute to therapies for people living with rare genetic diseases.
• Operate within a quality-focused, highly regulated biotechnology manufacturing environment.