GMP Quality Assurance - Commercial

Summary

Join Syndax Pharmaceuticals as a Contractor, GMP Quality Assurance, Commercial and provide expertise and guidance on Good Manufacturing Practice for all Syndax commercial products. Adhere to applicable regulations and work with stakeholders to proactively identify compliance issues and risks and implement corrective actions and risk mitigation. You will be responsible for daily commercial GMP operations at Syndax CMOs, ensuring internal systems follow GMPs and Company policies and procedures. Collaborate with internal functions and external vendors to promote high quality and support a company-wide culture of sustainable GMP and Quality compliance. This is a contract position.

Requirements

• BS degree in scientific field required, advanced degree preferred
• Minimum of 2-4 years of experience in the pharmaceutical industry, including release of commercial product, within QA/GMP environment
• Small molecule experience required (drug substance/API, drug product, packaging and labeling) and QC/analytical
• Must have experience working in cross-functional teams including, CMC, analytical, supply chain, and regulatory affairs, medical affairs, and commercial
• Experience working with external vendors and suppliers including, drug substance/API, drug product, analytical, and/or secondary packaging and labeling
• Awareness of 21 CFR 210/211 and Part 11, ICH GMP, and applicable global regulations
• Strong technical writing skills
• Excellent communication skills
• Strong judgment, project management and decision-making skills; able to manage multiple priorities and demanding timelines

Responsibilities

• Review and approve GMP batch records and associated documentation
• Support CMC with review of CMO documents including, specifications, methods, labeling, batch records, analytical testing, stability documents, COA/COC for commercial product
• Support validation efforts of new vendors for drug product, drug substance, and packaging/labeling of commercial product
• Support investigations into quality issues with focus on product impact and patient safety; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities, as appropriate
• Identify process improvement initiatives as requested by management
• Work closely with Quality Assurance team to ensure alignment and compliance with Syndax Quality Systems
• Support Quality Operations and Quality Systems tasks, as required
• Self-motivating and independent
• Work independently with guidance from manager and senior staff
• Must be able to articulate complex issues clearly verbally and written
• Author, review, and/or approval documents including deviations, SOPs, and protocols