Syntagma Group · 4 days ago
Director of Quality Control
Indianapolis, IN
Full-time
Onsite
Director/Executive
$175K/yr - $200K/yr
10+ years expSyntagma Group is seeking a Director of Quality Control who will be responsible for establishing, leading, and continuously improving quality control operations within a manufacturing environment. The role involves providing strategic and operational leadership for QC laboratories, ensuring compliance with regulatory requirements, and driving a culture of continuous improvement.
ConsultingRecruitingStaffing Agency
Hiring Manager
Daniel Viscariello
Responsibilities
Provide strategic leadership and oversight of all Quality Control laboratory operations, including chemical, physical, and/or microbiological testing as applicable
Ensure laboratory activities comply with applicable regulations, standards, and internal procedures (e.g., FDA, ISO, cGMP, GLP)
Establish and maintain robust test methods, specifications, sampling plans, and laboratory controls
Oversee laboratory equipment qualification, calibration, validation, and maintenance programs
Ensure timely and accurate release of raw materials, in-process materials, and finished goods
Lead laboratory investigations related to out-of-specification (OOS), out-of-trend (OOT), and atypical results
Lead or chair the Material Review Board to ensure effective evaluation and disposition of nonconforming materials and products
Ensure MRB decisions are data-driven, compliant, and aligned with risk-based quality principles
Collaborate with Manufacturing, Engineering, Supply Chain, and Quality Assurance to determine root cause, disposition, and corrective actions
Track MRB trends and metrics to drive systemic improvements and prevent recurrence
Own and oversee the CAPA system, ensuring timely, effective, and compliant corrective and preventive actions
Ensure thorough root cause analysis using structured problem-solving methodologies (e.g., 5 Whys, Fishbone, FMEA)
Monitor CAPA effectiveness and closure, ensuring sustained improvements
Analyze quality data and trends to proactively identify risks and improvement opportunities
Drive a culture of continuous improvement and quality excellence across the organization
Build, lead, and develop high-performing QC teams, including laboratory scientists, technicians, and supervisors
Set clear performance expectations, conduct regular performance reviews, and support employee development
Ensure appropriate staffing, training, and succession planning within QC operations
Promote a strong quality culture focused on compliance, accountability, and continuous learning
Support internal, customer, and regulatory audits and inspections related to Quality Control
Ensure audit observations related to QC, MRB, and CAPA are addressed effectively and on time
Establish and report key quality metrics (KPIs) to senior leadership
Ensure data integrity and documentation accuracy across all QC systems
Qualification
Required
Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline required
10+ years of progressive experience in Quality Control within a manufacturing environment
5+ years in a leadership or management role
Demonstrated experience managing QC laboratories, MRB processes, and CAPA systems
Strong background in regulated manufacturing environments (e.g., FDA, ISO, GMP)
Deep understanding of quality systems, laboratory operations, and regulatory requirements
Proven leadership and people management skills
Strong analytical, problem-solving, and decision-making abilities
Excellent communication and cross-functional collaboration skills
Experience using quality data to drive continuous improvement
Preferred
Advanced degree (Master's or PhD)
Company
Syntagma Group
Syntagma Grp. offers consulting services in recruiting, talent acquisition, and tailored financing solutions for real estate.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Anthony Zarro
Talent Partner (Full-Time, Contract, Executive Search)
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