Director of Quality - Biologicals and Chemicals Division

Position Summary 

TheDirector of Quality - Biologicals and Chemicals Divisiony provides global quality leadership across the Cell Culture Media Network, spanning multiple manufacturing sites (e.g., Grand Island, Inchinnan, Miami). Reporting to the Sr. Director of Quality, this role is accountable for the performance, compliance, and continuous improvement of the Manufacturing Quality function across the network. The Director ensures consistent application of Quality Management Systems, ensures product quality, drives harmonization across sites, and aligns quality strategy with business objectives, customer expectations, and regulatory requirements. 

Key Responsibilities 

• Lead and execute the network-wide Manufacturing Quality strategy aligned with BCD Quality operating model 

• Provide end-to-end Quality leadership across multiple manufacturing sites, ensuring compliance to ISO 13485, FDA 21 CFR 820, MDSAP, and applicable global standards 

• Drive harmonization and standardization of Quality processes, systems, and metrics across the network 

• Own network product Quality performance, including primary KPIs related to complaints, cost of poor quality (COPQ), and manufacturing health, and other metrics as required to ensure the health of manufacturing quality processes. 

• Lead and develop a global team across Quality Engineering, QMS, laboratories, and product release functions 

• Partner with Operations, R&D, Regulatory Affairs, and Commercial teams to ensure successful product lifecycle management 

• Drive proactive quality engineering strategies and continuous improvement initiatives (e.g., Lean Six Sigma) 

• Oversee and govern complaint and nonconformance management across the media network sites 

• Serve as escalation point for critical quality issues and ensure timely containment and resolution 

• Lead customer and regulatory interactions, including audits, inspections, and issue resolution 

• Enable execution readiness for regional capacity expansion and new product introductions 

• Establish and maintain a strong culture of quality, accountability, and continuous improvement across the network 

Leadership & Governance 

Maintain centralized Quality governance across the network while supporting site-level execution through matrix leadership. Ensure consistent decision-making, escalation pathways, and performance management across regions. Drive Management Review processes at network level and ensure alignment with enterprise quality objectives. 

Qualifications 

• Bachelor’s degree in Science, Engineering, or related field (advanced degree preferred) 

• 10+ years of Quality experience in regulated industries  

• 5+ years of leadership experience in multi-site or global quality organizations 

• Deep knowledge of GMP, ISO standards, FDA regulations, and global quality systems 

• Demonstrated experience leading cross-functional and multi-site initiatives 

• Strong leadership, communication, and decision-making skills 

• Experience in continuous improvement methodologies (Six Sigma, Lean) 

• Ability to operate in a global, matrixed organization