Manager, Quality - QC Analytical

How You'll Make an Impact:

The Quality Control Manager in San Clemente, CA oversees all QC laboratory operations and testing activities. This role supervises QC staff, ensures compliant and efficient lab execution, maintains cGMP compliance and data integrity, and provides technical leadership while keeping the laboratory inspection-ready and supporting project teams as needed.

What You'll Do:

General laboratory Management

• Oversees and assigns raw material, in-process, finished product, and stability testing across multiple pharmaceutical products to ensure timely batch release and stability commitments
• Manages cGMP stability programs for clinical and commercial products and performs trend analysis to identify risks or emerging issues
• Oversees the internal reference standard qualification, lifecycle management, and documentation program
• Oversees method validations, verifications, transfers, and feasibility studies to support product development and commercialization
• Oversees audit trail review process and 21 CFR Part 11 compliance
• Evaluates internal versus external testing strategies and recommends improvements to optimize efficiency, cost, and compliance
• Recommends laboratory equipment, instrumentation upgrades, and new technologies to support future QC capability needs
• Oversees qualification and calibration of analytical equipment and approves vendor qualification documentation, may include URS development, IQ/OQ/PQ approval authority, equipment lifecycle planning, obsolescence strategy
• Monitors contract testing laboratories, reviews external analytical data, and ensures CRO/CMO compliance with quality standards
• Identifies and resolves technical challenges impacting method transfer, assay implementation, and laboratory operations
• Responsbile for laboratory budget management such as headcount forecasting, consumables planning, and alignment on capital expenditure planning

Documentation & Compliance

• Reviews and approves analytical data, laboratory documentation, and Certificates of Analysis to ensure accuracy, completeness, and data integrity
• Oversight of audit trail review process
• Authors and/or reviews laboratory investigations (OOS, OOT, deviations) and ensures appropriate root cause analysis, impact assessment, and corrective actions
• Authors, reviews, and approves analytical methods, validation protocols, qualification reports, and stability reports to ensure regulatory compliance
• Provides annual product quality review analytical input
• Ensures QC documentation, laboratory systems, and practices comply with ICH, USP, Pharm. Eur., JP, and applicable global regulatory guidelines
• Supports regulatory submissions by preparing or reviewing technical summaries
• Contributes to SOP development, process improvements, and continuous improvement initiatives within the laboratory

Inspection Readiness & Regulatory Activities

• Ensures QC maintains inspection readiness, compliance, and a culture of data integrity
• Serves as the primary technical lead for QC investigations and escalates significant quality risks appropriately
• Analyzes and interprets complex analytical data and provides scientifically sound conclusions to support quality and regulatory decisions
• Participates in regulatory inspections and supports responses to regulatory agencies as required
• Owns QC laboratory performance metrics and drives continuous improvement initiatives to improve efficiency and compliance

Team Leadership & Cross-Functional Support

• Supervises QC chemists, sets priorities, and ensures compliant execution of laboratory activities in accordance with cGMP requirements
• Responsible for QC chemist training matrix updates in coordination with training team
• Provides technical leadership, mentorship, development, and performance management for QC chemists
• Participates in cross-functional development and manufacturing meetings as QC representative
• Communicates QC priorities, timelines, and risks to stakeholders and leadership
• Collaborates with R&D to assess and implement specialized analytical approaches, when applicable
• Ownership of QC lab related change control or technical impact assessments and CAPA approval authority
• Employing technical knowledge to assist with Quality risk management (FMEA) and risk management during Quality investigations

Digital and Automation Strategy

• Oversee implementation of LIMS / electronic notebooks
• Improve digital data analytics

How You'll GetThere:

• 8+ years of experience in analytical chemistry within Pharmaceutical QC environment.
• Minimum of 1 year of previous management experience in Pharmaceutical QC laboratory, including supervision of QC chemists.
• Demonstrated leadership skills with the ability to prioritize workload, mentor staff, and ensure inspection readiness and cGMP compliance.
• Experience managing and overseeing external contract testing laboratories (CROs/CMOs) is preferred.
• Understanding of analytical platforms including HPLC, FTIR, UV/Vis, and Drug Release.
• Experience overseeing analytical method validation, verification, method transfer activities, and management of cGMP stability programs.
• Working knowledge of ICH guidelines, major pharmacopoeias (USP, Ph. Eur., JP), CTD structure, and global regulatory expectations.
• Strong analytical skills (interpret data, summarize data, present data).
• Strong written and verbal communication skills. ·
• Motivated and able to work independently, as well as within a team. Exhibits personal integrity, credibility, and responsibility. ·
• Excellent organizational skills and ability to work on multiple projects/tasks. ·
• Meets milestones and schedules.
• Bachelor's degree in a scientific discipline is required