Quality Assurance Manager

Quality Assurance Manager – Pharmaceutical Oral Solid Dosage

The Quality Assurance Manager is responsible for the strategic oversight, execution, and continuous improvement of the Site Quality Management System (QMS), product disposition, document control, personnel training, and market vigilance (customer complaints) at our pharmaceutical manufacturing facility. This role ensures that all operations comply fully with current Good Manufacturing Practices (cGMP), US FDA regulations (21 CFR Parts 210, 211, and Part 11), ICH Q10, state regulations, and corporate compliance standards by maintaining an inspection-ready, fully qualified, and highly responsive manufacturing site.

• Drive the compilation and advanced statistical modeling of data for the Annual Product Quality Review (APQR) and monthly QMRs, delivering actionable data-driven metrics to site executive leadership.
• Establish and champion the site's Statistical Process Control (SPC) program. Monitor and analyze critical quality attributes (CQAs) and critical process parameters (CPPs) using control charts to identify out-of-control trends before deviations occur. Apply Six Sigma tools (DMAIC, Gauge R&R, ANOVA, Capability Indices like Cp/Cpk) to lead cross-functional variance reduction projects, targeting systemic manufacturing defects and minimizing product variability.

• Manage the site batch record review and product disposition process to ensure all incoming materials, WIPs and finished products meet established specifications prior to market distribution.
• Review and approve Certificates of Analysis, Certificates of Conformance (CoC), and final batch release documentation under 21 CFR 211.192.
• Direct the control, segregation, and disposition of quarantined, rejected, or reprocessed raw materials, intermediates, and finished solid dosage products based on rigorous statistical and scientific evaluations.

• Lead and approve formal investigations for quality events and Customer Complaints (PQCs) by utilizing statistical analysis to implement.
• Implement risk management approaches to identify, mitigate and eliminate risk to the product quality.
• Drive the definition and timely execution of Corrective and Preventive Actions (CAPA) using advanced root cause analysis (RCA) tools to mitigate systemic equipment and market defect issues.

• Oversee the site Document Control center. Manage the full lifecycle (authoring, formatting, workflows, multi-layer approvals, issuance, archiving, and obsolescence) of all GxP documents, including Standard Operating Procedures (SOPs), Master Batch Records (MBRs), specifications, validation protocols, and logbooks.
• Serve as the site gatekeeper for Data Integrity, ensuring strict adherence to 21 CFR Part 11 and ALCOA++ principles across all paper-based records, hybrid records, and automated electronic system outputs.

• Provides direct interface with FDA and other regulatory agencies and customers during inspections.
• Performs assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within QMS.
• Establish programs to promote quality awareness and compliance.

• Education:
  
  Bachelor’s degree (B.S.) in Chemistry, Pharmacy, Chemical Engineering, Statistics, or a related scientific discipline. Advanced degree is preferred.
• Minimum of 6+ years of progressive QA/QMS experience in quality assurance, quality oversight or relevant experience.
• Technical knowledge in as many of the following areas as possible: quality, regulatory, process sciences, manufacturing operations.
• Knowledge and familiarity with products, processes, equipment and facilities of pharmaceutical related products.
• Knowledge of QA systems and GMP compliance requirements including regulations and standards affecting pharmaceutical products.
• Leadership: Proven ability to manage cross-functional projects and lead…