Job Description
We're seeking an experienced Operations Manager for our operations team. This role is key to ensuring operational excellence, regulatory compliance, and seamless cross-functional collaboration in a fast-paced, high-growth environment.
Key Responsibilities:
Operations Management:
Oversee all day-to-day operations including production, inventory, supply chain, logistics, and process optimization.
Drive efficiency, scalability, and cost-effectiveness across the value chain.
Team Leadership:
Lead, mentor, and develop a multidisciplinary operations team (Production, QA/QC, Supply Chain).
Foster a high-performance, accountability-driven culture with clear communication of goals and KPIs.
Production Oversight:
Manage daily and long-term production planning to meet delivery timelines, quality standards, and regulatory requirements.
Regulatory Compliance:
Ensure all operational activities comply with applicable regulations: FDA (21 CFR Part 820), IVDR, ISO 13485, and other global standards in biotech/diagnostic manufacturing.
Continuous Improvement:
Champion Lean, Six Sigma, or similar methodologies to optimize workflows, minimize waste, and enhance product quality.
Cross-Functional Collaboration:
Partner closely with R&D, Quality, Regulatory, Supply Chain, and Commercial teams to align operational strategies with business objectives.
Budget & Cost Management:
Build and manage operational budgets, monitor expenses, and identify cost-saving opportunities while maintaining quality and compliance.
Requirements
Education: Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related field. Master's or MBA preferred.
Experience: 10+ years in biotech, diagnostics, or medical device manufacturing, with 5+ years in leadership roles managing cross-functional operations teams.
Strong track record of role stability (30+ months average tenure) and career progression, with experience at 7 or fewer companies preferred.
Regulatory knowledge: Solid understanding of FDA 21 CFR Part 820, ISO 13485, IVDR, and other global quality standards. Proficiency with ERP systems and operating in highly regulated environments.
Operational & leadership skills: Proven success driving Lean, Six Sigma, or continuous improvement initiatives.
Strong operational planning, budgeting, and problem-solving capabilities.
Collaborative leader with excellent team-building, communication, and decision-making skills.
Preferred Attributes: Resourceful, data-driven, and comfortable in growth-stage or scaling environments.
Strong business acumen with an operational mindset.
Benefits
- Highly competitive compensation package.
- Comprehensive medical, dental, and vision insurance.
- 401(k) plan with generous company contributions.
- Flexible paid time off (PTO) policy.
- Additional substantial benefits.
Equal Opportunity Statement: We are an equal opportunity employer committed to inclusion and diversity. We do not discriminate based on race, gender, religion, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any other protected characteristic.
Qualification
Bachelor's Degree
Key skill Required
- Manufacturing
- Budgeting
- Cost Management
- Logistics
- Accountability
- Biotechnology
- Business Objectives
- Clear Communication
- Collaboration
- Communication
- Compliance
- Comprehensive
- Effectiveness
- Insurance
- ISO 13485
- Leadership
- Management
- Medical Device
- Medical Device Manufacturing
- Multidisciplinary
- Operational Activities
- Operational Planning
- Operations Management
- Optimization
- Orientation
- Process Optimization
- Product Quality
- Production Planning
- Quality Standards
- Regulatory Compliance
- Regulatory Requirements
- Resourceful
- Scalability
- Scaling
- Six Sigma
- Supply Chain
- Team Leadership
- Vision Insurance
