CQA Team Leader

BioSpace; Home (KS); Remote; USD 120,000 - 160,000; Full time

Job summary

Sanofi in the United States is seeking a CQA Team Leader (Remote) to manage a team of auditors and drive training, coaching, and development. You will support clinical projects through audits, inspections, quality reviews, and GCP guidance, leading improvement initiatives and ensuring compliant processes.

As part of the Clinical Quality Assessment leadership, you will shape audit strategies, allocate resources, and mentor staff while collaborating with global teams and regulatory bodies.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 10 years with a bachelor’s or 5 years with an advanced degree.
• 5+ years in Clinical Quality Assessment and/or Clinical Trials.
• Extensive knowledge of international regulations and GCP.
• Strong business English communication skills.
• Experience with digital transformation and agile methods.

Responsibilities

• Oversee day-to-day performance of auditors with coaching and training on ICH/GCP and regulatory requirements.
• Directly manage team objectives, performance and development plus hiring as needed.
• Contribute to annual goals and audit strategy planning and updates.
• Lead audit planning, schedules and revisions of audit strategies.
• Ensure quality of audits, reporting, follow-up per procedures.
• Apply data quality controls and leverage AI for risk-based insights.

Skills

Audit leadership

Quality systems

Regulatory knowledge

GCP knowledge

Project management

Education

Bachelor's degree in Life Sciences

Advanced degree

Tools

CTMS

Data analytics

Job description

Job title: CQA Team Leader Location: Remote, US

About the job

The CQA Team Manager (CQA TM) has direct management and supervisory responsibility of a team of auditors and is primarily responsible for ensuring the training, coaching, motivation and development of the individuals in his / her team. The CQA TM leads and inspires them to maximize their capabilities, performance and overall utility. By doing this the TM ensures that clinical projects are properly supported through independent clinical audit assessments, inspection management, quality reviews and GCP advice in relation to audit and inspection activities, that audit activities are effectively conducted, and ensures continuous improvement of the quality standards to meet regulatory requirements. This position reports to the Head of Clinical Quality Assessment and is an active member of the management team for the group. Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

Main responsibilities

• Strategic Risk Based Audits Oversees day-to-day performance of individuals ensuring appropriate coaching and training on ICH/GCP, relevant regulatory requirements and global, departmental and geographical QDs, policies and guidelines.
• Directly manages his/her team and business support staff, including objectives & performance management, individual development, administrative matters, and hiring as necessary.
• As part of the management team participates in the development of annual goals and objectives of the department.
• Directly leads and plays a key role in audit planning, actively participates in the development of the annual schedules and regular revisions of audit strategies.
• In collaboration with CQA Management team, contributes to the development, review and updates of the policies, procedures, guidelines and other standards, and ensures their implementation within his/her team
• Ensures appropriate implementation of planned audits and ensures his/her team resources are put to optimum use for all types of audits assigned, and ensures that skills are developed at team level.
• Responsible for the quality of the audits conducted by his/her team, including adequate conduct, reporting and follow-up of the audit activities as per departmental procedures, guidelines, etc.
• Ensures a quality driven risk-based approach to audit scope and reviews.
• Ensures the contribution of all members of his/her team to support key customers and provide GCP consultation in relation to audits and inspections, regulation interpretation and input / communication on functional or cross functional procedures. This includes support to internal and external clients for activities that support continuous improvement cycle such as Quality Reviews, participation in workgroups, etc.
• Participates in audits as needed with emphasis on complex objectives and/or as part of audit staff coaching, training, and assessment.
• During Investigator site audits, CQA Team Manager has direct access to subject individual data for records review and may have access to unblinded information/data. He/she is bound by professional secrecy and as such will not disclose any individual identity and/or individual medical information.
• Utilize predictive analytics and real-time data insights to identify potential risks and opportunities associated with clinical trials. Asses and escape those risks as needed.
• Leader in determining the needs and designing the associated strategy for assessing audit and inspection quality trends / alerts via Transversal Quality Reviews (service provider / process).
• Ensure assignment of appropriate resources for the development and delivery of Quality Reviews to functions and leadership teams.
• Under Head of CQA oversight, coordinates and supports the control and follow-up of outsourced / contracted GCP assessment activities.
• Inspection Activities: Leader in coordination and support and/or directly participates in the inspection activities by regulatory / compliance monitoring authorities. Will hold leadership roles such as Inspector facing host, backroom manager, and QC lead.
• Lead and coach team members in:the coordination and management of pre-inspection preparation visits, providing support to the inspection conduct, hosting site level inspections, overseeing post regulatory inspection follow-up activities.
• Process Optimization : Apply critical thinking to develop and implement data quality control measures, leveraging AI and machine learning for enhanced accuracy. Participate in streamlined digital workflows that reduce manual processes and enhance operational efficiency Participate in the development of quality documents, digital tools and processes to enhance efficiencies.

Basic Qualifications

• 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, with a demonstrated track record of strong performance.
• Extensive working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain.
• Good working knowledge of standard computerized software.
• Good business communication skills in English (orally / in riting)
• General management experience with technical / scientific staff
• Demonstrated knowledge in digital transformation and agile methodologies.

Key Competencies

• Proficient in clinical trial management systems, data visualization tools, and digital collaboration platform.
• Ability to translate data into actionable insights and strategic recommendations.
• Be organized and autonomous in decision making.
• Ability to communicate clearly, and effectively, to foster a productive dialogue and to do so across multi-cultural environments and in complex and/or sensitive situations.
• Effective people management and leadership skills, including the ability to serve as a change agent.
• Ability to work as a team builder, listening, promoting exchanges, mentoring and coaching.
• Motivating a team to support decisions and directions in times of change.
• Technical 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.

Why choose us?

Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether its through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Be part of a pioneeringbiopharmacompany that engages patients early in drug development and uses their insights to design studies that reflect real-world needs. Help improve the lives of millions of people globally by making drug development quicker and more effective. Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to sparknew ideasand drive breakthroughs. Take good care of yourself and your family, with wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave. Join our Clinical Quality Assessment team and contribute to ensuring the quality of our clinical trials, through a risk-based and digital approach, and help accelerate medical breakthroughs.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.