CQA Team Leader

🕒 September 16

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $133.5k - $192.8k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Sanofi

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2004

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

💰 Post-IPO Equity on 2022-03

Healthcare • Manufacturing • Logistics

Sanofi is a global healthcare company focused on pharmaceutical innovations and improving people's lives through advancements in science. The company is deeply engaged in research and development across several medical fields, including immunology, neurology, oncology, rare diseases, and vaccines. Sanofi is also dedicated to consumer healthcare, with efforts to enhance physical and mental wellness, allergy care, and treatments for cough, cold, and flu. In addition, Sanofi employs artificial intelligence in its research efforts and emphasizes environmental sustainability, diversity, and inclusion as part of its social impact agenda. With a strong commitment to transforming healthcare for vulnerable communities and leading scientific collaborations worldwide, Sanofi plays a significant role in the pharmaceutical and healthcare industries.

📋 Description

• Manage and supervise a team of auditors • Ensure training, coaching, motivation, and development of team members • Support clinical projects through independent clinical audit assessments, inspection management, quality reviews, and GCP advice • Oversee day-to-day performance, objectives, performance management, development, administrative matters, and hiring • Participate in departmental annual goals and objectives • Lead audit planning and development of annual audit schedules and audit strategies • Contribute to policies, procedures, guidelines, and standards and ensure team implementation • Ensure implementation of planned audits and optimal use and development of team resources • Ensure quality conduct, reporting, and follow-up of team audit activities • Provide GCP consultation, regulatory interpretation, and support for internal and external clients • Participate in complex audits and coach, train, and assess audit staff • Use predictive analytics and real-time data insights to identify and escalate clinical trial risks • Lead assessment of audit and inspection quality trends and alerts through Transversal Quality Reviews • Coordinate outsourced or contracted GCP assessment activities • Coordinate, support, and participate in regulatory inspection activities • Lead pre-inspection preparation, inspection conduct support, site-level inspections, and post-inspection follow-up • Develop and implement data quality controls using AI and machine learning • Participate in digital workflows, quality documents, tools, and processes to improve efficiency

🎯 Requirements

• Bachelor's degree in Life Sciences, Medical Sciences, Natural Sciences, or a related scientific discipline, or equivalent experience • Minimum 10 years of relevant experience with a bachelor's degree, or 5 years of relevant experience with an advanced degree • Minimum 5 years of Clinical Quality Assessment experience and/or experience in Clinical Trials, including Monitoring or Clinical Trial Management • Demonstrated track record of strong performance • Extensive working knowledge of international regulations, guidelines, and Good Practices pertaining to the clinical domain • Good working knowledge of standard computerized software • Good business communication skills in English • General management experience with technical/scientific staff • Demonstrated knowledge in digital transformation and agile methodologies • Proficiency in clinical trial management systems, data visualization tools, and digital collaboration platforms • Ability to translate data into actionable insights and strategic recommendations • Ability to communicate effectively across multicultural environments and complex or sensitive situations • Effective people management and leadership skills • Expertise in clinical trial management systems and eClinical platforms • Proficiency in data visualization and analytics tools • Understanding of digital health technologies and their application in clinical trials • In-depth working knowledge of current regulations, guidelines, and good practices pertaining to clinical development • US and Puerto Rico residency

🏖️ Benefits

• Supportive, future-focused team • Opportunities for promotion or lateral career moves, at home or internationally • Rewards package recognizing contribution • Health and wellbeing benefits • High-quality healthcare • Prevention and wellness programs • At least 14 weeks’ gender-neutral parental leave • Opportunities to collaborate with diverse teams across science, clinical, and digital fields

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