The Director of Quality Assurance is responsible for quality assurance and compliance operations. The Director of Quality Assurance will establish GMP quality plans and policies and report to management on a regular basis on compliance activities and findings. He/she will design, implement, and maintain QA and compliance programs and infrastructure, including an SOP system, and perform internal and external GMP audits (as needed). 

Duties and responsibilities

Development and Commercial Quality Responsibilities include:

• Design and maintain GMP compliance for Venatorx programs to support clinical studies, future product registration, and commercial.
• Provide GMP Quality Assurance oversight of vendors and maintain quality agreements.
• Write, review, approve, and maintain GMP Standard Operating Procedures
• Responsible for directing the review of manufacturing/packaging batch records as well as release and disposition of drug substance and drug product batches.
• Direct the quality review of process and analytical validation protocols and reports.
• Review and approve stability study protocols/reports and assignment of retest/expiry dates.
• Responsible for review and approval of OOS, deviations, and product complaint investigations.
• Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, compliance to applicable Venatorx SOPs, GMP regulations and applicable country specific standards.
• Participate in compliance (GMP) auditing program (internal and external) to fulfill regulatory requirements.
• Ensure regulatory audit readiness internally and externally which including the coordination of pre-PAI audits, training of SMEs and other Venatorx employees, and ensuring that documentation will be readily available during a potential regulatory audit.
• Ensure CAPA findings from GMP audits and regulatory inspections are effectively investigated and closed out.
• Provide expertise and guidance to Venatorx departments in interpreting and implementing governmental and agency guidelines to assure GMP compliance.
• Follow applicable regulations, including FDA, ICH, GMP, and Venatorx policies and procedures.
• Ensure that direct reports and consultants have completed the training necessary for their assigned responsibilities.
• Represent QA at project team meetings

Qualifications

• Minimum BS, Master’s degree or PhD with focus in Engineering, Life sciences, or another similar technical field

• 15 (BS), 8 (MS), 6 (PhD) years of relevant and current work experience in the pharmaceutical industry. Quality Assurance required.
• Solid and demonstrable knowledge of international GMP regulations and guidelines, industry practices, and experience implementing Quality Systems in a regulated environment.
• Working knowledge of GxP international regulations
• Strong organization and time management skills.
• Attention to detail with an ability to perform critical review of various types of documents.
• Outstanding written and verbal skills
• Ability to independently solve problems and work cross-culturally.
• Demonstrated ability to work as a team player with multi-disciplinary project teams.

Venatorx is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law. 

For more information, please check out our website: www.venatorx.com