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Sr. Manager, GCP QA, Amunix, U.S. Remote

POSITION SUMMARY

This position will support the GCP QA function at Amunix, executing GCP QA activities related to clinical product development and clinical studies. This position will interact cross-functionally to provide GCP and compliance support for ongoing and new clinical studies led by the Amunix Clinical team. This position will also assist with management of local quality systems and processes while ensuring compliance with corporate requirements as well as US and EU GCP regulations and guidelines. This position will report to the Head of GCP QA, Amunix.

ESSENTIAL FUNCTIONS

• Provide GCP QA oversight and support cross-functionally and to CROs.

• Represent GCP Quality interests in project meetings for Amunix projects

• Ensure the timely and effective follow up of all identified or assigned quality issues and escalation as needed.

• Assist with the development and management of local Clinical SOPs and other quality documents, as required.

• Identify, communicate any internal and CRO Quality Issues/Deviations for a study in a pro-active and collaborative manner. Escalate any major and/or critical issues for risk assessment to Sanofi as necessary.

• Communicate and escalate any Data Privacy related issues to Sanofi as necessary.

• Assist with management of study specific training and GXP training records, working collaboratively with Sanofi colleagues.

• Maintain local quality systems processes and procedures, and ensure alignment between local and corporate requirements

• Conduct QA review of clinical protocols, ICFs, and other clinical trial specific documents

• Provide guidance for investigations as well as corrective and preventive action (CAPA) plans for compliance issues and/or observations.

• In collaboration with Sanofi colleagues, ensure suppliers and vendors of materials and services are audited and qualified, and establish Quality Agreements as required.

• Assist with quality assurance audits as required, to include:- clinical investigator sites, vendors, process, system, study project and document reviews to assure quality assurance compliance with regard to all internal procedures as well as regulatory guidelines.

• Support inspection readiness preparation internally and with suppliers and clinical sites, as applicable

• Administer and/or manage compliant electronic signature workflows to support GCP activities

QUALIFICATIONS

• 3 - 5+ years’ experience in Quality Assurance in a biotech or pharmaceutical environment

• BA or BS degree in a scientific discipline

• Experience with quality systems and clinical studies

• Working knowledge of MS Word, Excel, Adobe Acrobat and DocuSign

• Excellent organizational, time management and project management skills

• Proven ability to collaborate and communicate effectively

• Strong knowledge of current GCPs, FDA/EMA regulations, and ICH guidelines

• Proficient with relevant software and experience with electronic quality management systems

ABOUT AMUNIX

Amunix is leveraging our expertise in precision protein engineering to enable the promise of T cell engagers in solid tumors. Our goal is to save cancer patients’ lives through the development and commercialization of breakthrough therapies that harness the immune system. We have invented XTEN, a validated therapeutic half-life extension technology. Our current focus is Pro-XTEN, a next-generation protease activated pro-drug platform, which enables selective activation of potent cancer therapies in the tumor microenvironment. This overcomes a common challenge facing potent immune system activators: on-target, off-tumor toxicity. Amunix’s two lead programs employ the Pro-XTEN technology to enhance the safety profile of T cell engagers. XPATs (XTENylated Protease-Activated T Cell Engagers) have the potential to make off-the-shelf therapies redirecting T cells to solid tumors a reality.

Amunix provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Amunix complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfers, leaves of absence, compensation, and training.

HOW TO APPLY

To apply, please submit your cover letter and resume to

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.