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.
If you are interested in applying for this job, please make sure you meet the following requirements as listed below.
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 levelDirector Employment type
Employment typeFull-time Job function
Job functionOther IndustriesIT 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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If you are interested in applying for this job, please make sure you meet the following requirements as listed below.
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 levelDirector Employment type
Employment typeFull-time Job function
Job functionOther IndustriesIT 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 TransformationAssociate Director of Dining Operations, Marietta CampusAssociate Director, Regional Operations and Communications 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 EHCAssociate Director, Connections Strategy (CRM) Atlanta, GA $110,700.00-$143,900.00 2 weeks ago SENIOR PROJECT MANAGER ECONOMIC DEVELOPMENTDirector of Perioperative Patient Care ServicesSenior Project Manager ' Exhibits and Activations Norcross, GA $110,000.00-$130,000.00 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr