Contractor, Senior GMP Quality Assurance

Syndax Pharmaceuticals•Manhattan, NY

2d•Remote

About The Position

At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Role: Reporting to the Senior Director, Commercial Quality, Contractor, Senior GMP Quality Assurance will be responsible for lot review/release activities for drug substances, drug products, and finished goods by Contract Manufacturing Organizations (CMOs). Throughout the process, ensure Syndax, its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing, storage and distribution of products used for commercial distribution comply with cGMPs and standards established by company as well as regulations of applicable authorities.

Requirements

BS degree in scientific field required, advanced degree preferred.
Minimum of 10 years of experience in the pharmaceutical industry, within the 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.
Experience using QMS (including electronic systems), including documents and SOPs, change controls, deviations, product complaints, and annual product reviews.
Extensive understanding and application of 21 CFR 210/211 and Part 11, ICH GMP, and other applicable global regulations.
Experience preparing for and participating in GMP regulatory inspections.
Strong technical writing skills; ability to write clear quality position statements, and procedures.
Excellent communication skills.
Self-motivating, proactive and independent.

Nice To Haves

Familiarity with Veeva is a strong plus.

Responsibilities

Support commercial batch review and release activities for drug substance, drug product, and /or finished goods for all phases of development including review and approval of Master Batch Records along with executed batch records.
Leads and maintains effective relationships with Contract manufacturing and testing Organizations.
Provide support for Process Validation and Technical transfer activities with existing and new vendors. as needed.
Provide support to cross functional teams in GMP compliance interpretation, consultation, training, and recommendations.
Collaborates cross-functionally other functions, such as CMC, Regulatory, Development QA, as needed to ensure alignment and best practices.
Effectively interact with external contract manufacturers and testing laboratories as well as work as part of an internal multidisciplinary team to support manufacturing and testing of materials supporting Syndax development programs
Manage and address associated investigations, CAPAs, change controls, OOS, etc.
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 and mitigate GMP activities and process improvement initiatives as requested by management.
Work closely with the Quality Assurance team to ensure alignment and compliance with Syndax Quality Systems.
Support Commercial Quality activities like APQR, Mock Recall, etc.
Self-motivating and independent. Work independently with guidance from managers and senior staff.
Must be able to articulate complex issues clearly verbally and written.
Author, review, and/or approval of documents including deviations, SOPs, and protocols.