Director, Clinical Quality Assurance (Cqa)

Job Title: Director, Clinical Quality Assurance (CQA)

Reports To: Head of Quality Assurance

Department: Quality Assurance

SUMMARY:

This Director /Sr. Director, Clinical Quality Assurance (CQA) role will have the responsibility for effectively diagnosing issues, recommending solutions, and providing strategic CQA guidance across functions at Protagonist. Responsible for providing GCP/GLP compliance oversight and support to Protagonist's Clinical function and clinical study teams; and providing leadership, expertise, and guidance regarding regulatory requirements.

This position will report to the Head of QA and be an integral part of the QA team. In this role, the individual will utilize a risk-based strategy to prioritize activities, identify, and escalate compliance issues to enable pro-active decision-making, as necessary.

ESSENTIAL DUTIES AND RESPONSIBILITIES (includes but are not limited to):

• Provide Clinical QA leadership and oversight of Protagonist's clinical studies to ensure compliance with regulatory requirements and internal procedures.

• Clinical QA representative on Clinical Study Teams and other project teams.

• Support regulatory inspections and internal audits. Host inspections or audits when necessary.

• Respond to and help resolve issues related to inspection findings.

• Provide GCP/GLP training to functional areas and ensure the content satisfies regulatory requirements and GCP Guidelines.

• Develop risk-based strategies to set direction and prioritize Clinical QA support for clinical trial activities. Identify compliance issues and mitigation strategies to close the gaps.

• Manage Clinical Vendor Audit Plan and perform some Vendor Qualifications / Audits.

• Manage Clinical Site Audit Plan and perform some Clinical Site Audits.

• Manage GLP Audit Plan and perform Qualifications / Audits when necessary.

• Provide teams with GCP/GLP Audit results regarding the conduct of clinical or non-clinical studies and make appropriate recommendations.

• Monitor progress of Clinical Operations and Vendors to successfully respond with mitigation activities to close out Findings and Audit.

• Conduct QA reviews of Clinical Development essential documents (e.g. protocols, study plans, pharmacy manual, case report forms, tables and listings, informed consent forms, investigator brochures, and Clinical Study Reports), when necessary.

• Identify and escalate significant compliance issues, including the assessment of serious breaches and mitigation plans.

• Keep current on changes in industry and regulatory standards for GCP/GLP requirements and advise on business impact.

• Willing to travel (up to 30%), including international travel.

• Maintain flexibility to perform other additional tasks as assigned.

EDUCATION/EXPERIENCE/SKILLS:

• Bachelor's Degree in a scientific or related discipline with advanced degree preferred.

• Typically requires a minimum of 15+ years in biotech/pharmaceutical industry, with Quality Assurance experience.

• Experience with preparing for regulatory inspections, assessing inspection readiness, and hosting regulatory inspections & other audits.

• Comprehensive knowledge of GCP/GLP regulations and the ability to correctly interpret minimum standards are a must.

• Demonstrated expertise and ability to interpret and apply EU, FDA and ICH regulations and guidance documents.

• Experience with IRT and eTMF documentation software systems.

• Experience with Quality Systems (e.g. deviations, investigations, and CAPA programs).

• Self-motivated and comfortable with minimal direction.

• Proficient in organization, prioritization, time management, and able to manage multiple priorities.

• Proficient computer skills and experience with commonly used productivity software.

• Excellent oral and written communication skills.

• Demonstrated ability to work effectively and influence cross-functional teams.

• Strong focus on quality and attention to detail.

The base pay range for this position at commencement of employment is expected to be between $210,000 and $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

About Protagonist Therapeutics, Inc.

Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities (NCEs) rusfertide and JNJ-2113 (formerly PN-235) in advanced stages of clinical development, both derived from the Company's proprietary technology platform. Protagonist and Janssen scientists jointly discovered PN-235 (now known as JNJ-2113) as part of Protagonist's Interleukin-23 receptor (IL-23R) collaboration with Janssen and followed it through IND-enabling pre-clinical and Phase 1 studies, with Janssen assuming responsibility for further clinical development. Rusfertide, a mimetic of the natural hormone hepcidin, is the Company's lead drug candidate currently in a global Phase 3 development program. The randomized portion of the Phase 2 REVIVE study was unblinded, showing positive results and is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide