CorDx
4 weeks ago Be among the first 25 applicants
We are seeking an experienced and dynamic Associate Director of Operations to lead and scale our operational functions in a fast-paced, growth-stage IVD manufacturing environment. This senior leadership role is responsible for overseeing end-to-end operational activities, ensuring regulatory compliance, driving continuous improvement, and supporting business expansion objectives. The Associate Director will partner cross-functionally with R&D, Quality, Regulatory, and Commercial teams to align operational strategies with company goals and deliver operational excellence.
Key Responsibilities:
Operational Leadership:
Direct daily operations including manufacturing, inventory management, supply chain, logistics, and process optimization Develop and implement scalable operational strategies to support growth, quality, compliance, and customer service
Team Leadership:
Lead and mentor a high-performing team across Production, QA/QC, Supply Chain, and Engineering Build a culture of accountability, continuous improvement, and clear goal alignment
Production & Compliance Oversight:
Oversee production scheduling, capacity planning, and resource allocation Ensure adherence to FDA 21 CFR Part 820, ISO 13485, IVDR, and global regulatory standards Support audits, regulatory inspections, and supplier assessments
Operational Excellence & Improvement:
Champion Lean, Six Sigma, and continuous improvement practices to optimize workflows, reduce costs, and enhance product quality Identify and implement systems, processes, and technologies that improve operational scalability
Financial & Cross-Functional Management:
Develop and manage operational budgets and forecasts Collaborate with R&D, Quality, Regulatory, Finance, and Commercial teams to support business strategy and new product introductions
Requirements
Education:
Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related field required Master's degree or MBA preferred
Professional Experience:
10+ years of operational leadership in biotech, diagnostics, or medical device manufacturing 5+ years in senior management roles, leading cross-functional teams Experience in growth-stage or scaling environments preferred
Regulatory & Operational Expertise:
Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IVDR, and global quality standards Hands-on experience with regulatory audits, inspections, and operational risk management Proficiency with ERP and production planning systems
Leadership & Business Skills:
Proven ability to build and develop high-performing teams Strong skills in operational planning, budgeting, and data-driven decision-making Experience leading Lean or continuous improvement initiatives
Preferred Attributes:
Resourceful, results-driven, and effective in fast-paced, regulated environments Strong business acumen and operational insight Global or multi-site manufacturing experience a plus
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. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Other Industries IT Services and IT Consulting Referrals increase your chances of interviewing at CorDx by 2x Get notified about new Associate Director of Operations jobs in
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Key Responsibilities:
Operational Leadership:
Direct daily operations including manufacturing, inventory management, supply chain, logistics, and process optimization Develop and implement scalable operational strategies to support growth, quality, compliance, and customer service
Team Leadership:
Lead and mentor a high-performing team across Production, QA/QC, Supply Chain, and Engineering Build a culture of accountability, continuous improvement, and clear goal alignment
Production & Compliance Oversight:
Oversee production scheduling, capacity planning, and resource allocation Ensure adherence to FDA 21 CFR Part 820, ISO 13485, IVDR, and global regulatory standards Support audits, regulatory inspections, and supplier assessments
Operational Excellence & Improvement:
Champion Lean, Six Sigma, and continuous improvement practices to optimize workflows, reduce costs, and enhance product quality Identify and implement systems, processes, and technologies that improve operational scalability
Financial & Cross-Functional Management:
Develop and manage operational budgets and forecasts Collaborate with R&D, Quality, Regulatory, Finance, and Commercial teams to support business strategy and new product introductions
Requirements
Education:
Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related field required Master's degree or MBA preferred
Professional Experience:
10+ years of operational leadership in biotech, diagnostics, or medical device manufacturing 5+ years in senior management roles, leading cross-functional teams Experience in growth-stage or scaling environments preferred
Regulatory & Operational Expertise:
Strong knowledge of FDA 21 CFR Part 820, ISO 13485, IVDR, and global quality standards Hands-on experience with regulatory audits, inspections, and operational risk management Proficiency with ERP and production planning systems
Leadership & Business Skills:
Proven ability to build and develop high-performing teams Strong skills in operational planning, budgeting, and data-driven decision-making Experience leading Lean or continuous improvement initiatives
Preferred Attributes:
Resourceful, results-driven, and effective in fast-paced, regulated environments Strong business acumen and operational insight Global or multi-site manufacturing experience a plus
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. Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Other Industries IT Services and IT Consulting Referrals increase your chances of interviewing at CorDx by 2x Get notified about new Associate Director of Operations jobs in
Atlanta, GA . Associate Director, Value Transformation
Associate Director of Dining Operations, Marietta Campus
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Atlanta, GA $100,000.00-$125,000.00 3 days ago Atlanta, GA $93,000.00-$115,000.00 2 weeks ago Atlanta, GA $94,500.00-$105,000.00 1 week ago Atlanta, GA $150,000.00-$200,000.00 5 days ago Senior Project Manager - Process & Manufacturing
Atlanta Metropolitan Area $70.00-$75.00 2 days ago Atlanta, GA $70,000.00-$125,000.00 1 week ago Atlanta Metropolitan Area $85.00-$100.00 3 days ago Associate Director, Spiritual Health EHC
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Atlanta, GA $110,700.00-$143,900.00 2 weeks ago SENIOR PROJECT MANAGER ECONOMIC DEVELOPMENT
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