Job title: CQA Team Leader
Location: Remote, US
About the jobThe 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.
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 escalate 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 it's 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 pioneering biopharma company 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 spark new ideas and drive breakthroughs.
- Take good care of yourself and your family, with a 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
The salary range for this position is:
$133.500,00 - $192.833,33
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.
