Job Description

This is a fully benefited role, offering paid time off, holidays, sick leave, vacation, 401(k) match

Looking for a Senior Consultant with over 10 years of experience in the pharmaceutical and biotechnology industry, specializing in Quality Control (QC), Quality Systems, Analytical Method Validation , and Lab Management .

Education Requirement:

bachelor’s degree or higher in Chemistry or a related scientific discipline is required.

Key Responsibilities:

• Oversee and coordinate daily equipment qualifications in QC laboratories, collaborating with cross-functional teams to ensure timely execution.
• Lead analytical method validations , managing project timelines, resource allocation, and testing execution.
• Author and review technical documentation, including SOPs, test methods, validation master plans , and analytical reports in compliance with regulatory requirements.
• Support IQ/OQ/PQ execution, calibration activities , and overall lab readiness in coordination with internal departments.
• Provide oversight for change control processes , including authoring and reviewing documentation in systems such as TrackWise and Veeva Vault Quality Docs .
• Lead the digital transformation of QC systems as Product Owner for Empower CDS
• Manage operations in a high-throughput stability testing lab , leading a team of analysts and implementing Lean Lab and 5S principles to increase productivity and reduce costs.
• Conduct investigations (OOS, deviations) , perform risk assessments and root cause analyses , and implement CAPAs in alignment with cGMP and data integrity standards.
• Oversee data review and documentation compliance , developing and maintaining SOPs to meet evolving regulatory requirements.
• Coordinate stability programs end-to-end, including protocol updates, change control evaluations, and cross-functional collaboration with Regulatory, QA, and Supply Chain.
• Perform hands-on analytical testing for finished products, stability studies, and technical transfer, while reviewing data for regulatory filings and batch release.
• Provide technical leadership for LIMS and electronic data archiving systems , ensuring compliance with FDA and ICH guidelines during audits and inspections.
• Contribute to the creation and maintenance of product specifications for raw materials, APIs, packaging components, and finished products in accordance with USP, ICH , and CFR standards.

Tools & Systems:

• Empower CDS (Waters), TotalChrom
• TrackWise , LIMS , Veeva Vault Quality Docs, ComplianceWire

Key Areas of Expertise:

• Analytical Method Validation & Transfer
• Equipment Qualification (IQ/OQ/PQ); Change Control & CAPA Management
• Stability Program Oversight
• Data Integrity & ALCOA+ Principles
• GMP/GLP Compliance; Regulatory Submissions & Audit Readiness
• Laboratory Operations & Team Leadership

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