Director, Quality Assurance (Part-Time)

Syntagma Group; United States; Remote; USD 96,000 - 138,000; Part time

Job summary

Syntagma Group seeks an experienced GMP Quality Assurance professional for 25 hours/week of remote, part-time support for up to one year.

The role focuses on GMP/QMS oversight, audit support, vendor management, and CMC-related quality activities, collaborating with Technical Operations and external CDMOs. Advanced degree preferred; 10+ years in biotech QA expected.

Qualifications

• Bachelor’s degree in a scientific field; advanced degree preferred.
• 10+ years in biotech/pharma QA with increasing leadership.
• Deep knowledge of GMP and GxP regulations (FDA/EMA/ICH).
• Experience working with external CDMOs and cross-functional partners.
• Experience in early development and maturation of CMC QA processes.
• Familiarity with electronic records, data integrity, and computerized systems

Responsibilities

• Provide end-to-end GMP quality oversight for clinical manufacturing and disposition.
• Oversee vendor GMP compliance; review batch records and investigations.
• Lead deviations, OOS/OOT investigations and change controls.
• Support GxP vendor audits and internal QA audits as needed.
• Manage QMS activities in Veeva Vault including deviations and change controls.
• Ensure compliance with FDA/EMA/IHC guidelines and data integrity standards

Skills

Quality Assurance leadership

GxP regulations

FDA/EMA/ICH knowledge

Cross-functional collaboration

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Tools

Veeva Vault

Job description

100% Remote

***(Must reside in one of the following locations: MA, NY, FL, NC, CT, PA, MI, OH, NH, MD, CO, UT)

Our client is seeking experienced GMP Quality Assurance professional to provide part-time support.

• The position will require approximately 25 hours/week for approximately 1 year.
• The responsibilities are primarily GMP-focused (~80%) but the individual may also support other GxP activities, especially audit oversight and quality systems.

Responsibilities:

Support GMP compliance of manufacturing strategies

• Collaborate with Technical Operations team to provide Quality input for strategic CMC development activities, including but not limited to specification development, product release, stability, change management, and vendor management.
• Perform end-to-end Quality oversight for clinical manufacturing and disposition of products.
• Oversee GMP compliance of vendors by reviewing batch records, manufacturing investigations, product release, stability programs, etc.
• Perform batch record review and disposition related activities for drug substance, drug product, and final labeled drug product.
• Provide Quality oversight of method development, qualification, tech transfer, and analytical method validation for drug substance and drug product activities conducted at external labs and vendors.
• Lead process for reviewing manufacturing deviations, investigations, and OOS/OOTs, assessing impact to product quality and program.

GxP Quality Management

• Develop and maintain quality processes to support GMP and other applicable GxP activities.
• Review and provide QA input into procedural documents
• Maintain quality oversight of GMP vendors.
• Oversee audits of other GxP vendors and conduct or support internal audits as required.
• Manage complaints, deviations, and change controls from GMP vendors within Veeva QMS system.
• Oversee GxP computerized system validation activities, including periodic reviews.
• Manage the development, implementation, maintenance and improvements of GxP computerized systems to ensure compliance with current industry standards and health authority guidance.

Qualifications:

• Bachelor’s degree in a scientific field; advanced degree preferred
• 10+ years of experience in the biotech/pharmaceutical industry, primarily within Quality Assurance, with increasing responsibility and leadership roles
• Technical expertise with small molecule drugs
• Experience working with external CDMOs and technical consultants as well as with internal cross-functional stakeholders and senior leadership
• Experience working in early development and supporting maturation of CMC strategies/Quality processes to later development
• In-depth knowledge of GMP and GxP regulations and guidelines, including FDA, EMA, and ICH requirements
• In-depth knowledge of global regulations for electronic records, electronic signatures, data integrity, and computerized system compliance expectations
• Experience with Veeva Vault modules (QualityDocs, QMS, RIM)