The Director – Quality Assurance and Control Systems is responsible for defining, implementing, and maintaining robust Quality Management Systems (QMS) and Control strategies across all stages of production, testing, and release. This role ensures products and processes meet regulatory, internal, and customer quality standards through data-driven decision-making, quality culture leadership, and system-level controls.
The director leads QA/QC operations, ensures compliance with industry regulations (e.g., FDA, ISO, GMP), and drives continuous improvement across quality processes, control instrumentation, and digital quality platforms.
Develop and lead the Quality Assurance and Control Systems strategy, aligning with business goals, regulatory requirements, and customer needs.
Oversee QA/QC operations, including incoming inspection, in-process checks, final product release, and deviation management.
Ensure compliance with GMP, ISO 9001/13485, FDA 21 CFR Part 11, and other applicable standards.
Lead the validation and qualification of manufacturing processes, equipment, and computerized systems (CSV).
Implement digital quality systems (e.g., QMS software, LIMS, CAPA, document control platforms).
Establish and monitor Key Quality Indicators (KQIs) across facilities and departments.
Lead internal/external audits, supplier quality assessments, and regulatory inspections.
Coordinate cross-functional teams for root cause analysis (RCA), risk assessments (FMEA), and implementation of CAPAs.
Develop quality training programs to build awareness and compliance across teams.
Partner with R&D, operations, regulatory, and IT to ensure end-to-end quality integration.
Quality Management Systems (QMS) Leadership
Design and oversee implementation of enterprise QMS
Standardize quality policies, SOPs, and documentation control systems
Regulatory Compliance & Inspection Readiness
Maintain a state of compliance with local and global regulatory agencies
Lead audit response planning and remediation execution
Quality Control Technologies & Infrastructure
Oversee calibration, qualification, and performance of laboratory and in-line QC instrumentation
Ensure statistical process control (SPC), PAT (Process Analytical Technology), and LIMS integration
Risk Management & Continuous Improvement
Drive root cause investigations, CAPA execution, and continuous quality improvements
Implement FMEA, HACCP, and other risk-based approaches
Digital Transformation & Data Integrity
Deploy digital tools for real-time quality data collection, trending, and dashboards
Ensure data integrity principles (ALCOA+) are embedded in systems and practices
Supplier Quality & External Partner Oversight
Evaluate and qualify vendors, contract manufacturers, and service providers
Conduct supplier audits and manage incoming material quality assurance
Leadership & Culture of Quality
Lead, mentor, and grow QA/QC teams across functions and geographies
Embed quality culture into operations, with clear accountability and training
Education:
Bachelor’s or Master’s in Quality Assurance, Life Sciences, Engineering, Pharmacy, or a related field
Certified Quality Professional (CQA, CQE) or Six Sigma Black Belt preferred
Experience:
10+ years of experience in quality assurance/control in regulated industries
5+ years in leadership roles managing quality systems and teams
Experience in FDA/EMA/ISO-regulated environments (e.g., pharma, diagnostics, medtech, or food sectors)
Technical Competencies:
Strong knowledge of QMS platforms (e.g., MasterControl, Veeva, TrackWise)
Proficient in GxP regulations, validation lifecycle (IQ/OQ/PQ), and electronic records compliance
Familiarity with LIMS, SCADA, MES, and data analytics tools
Leadership Competencies:
Excellent communication, change management, and strategic thinking skills
Proven ability to drive cross-functional quality initiatives in matrixed organizations