Reporting into the VP, Quality Systems, the Senior Manager, Clinical Quality Assurance, will work proactively and collaboratively with our Clinical Operations and Data Management teams to ensure the successful delivery of high quality clinical studies aligned with Good Clinical Practices (GCP) and applicable regulations. The Senior Manager, Clinical Quality Assurance will also be responsible for developing and managing systems to improve quality and overall performance in Clinical Operations and data management. Further, this individual will work as a member of our Quality Systems team to ensure organizational alignment with the Quality Management System (QMS) and sharing of better practices in support of the QMS. By fulfilling these responsibilities, the individual will aid in ensuring the high-quality execution of clinical studies/programs in adherence to business plans.
Clinical Quality Assurance:
Determine, negotiate and agree on in-house quality procedures, standards and supporting documentation including interpretation and implementation of quality assurance standard.
Work with operations staff to establish adequate procedures, standards and systems. Draft quality assurance policies and procedures and ensure review and approval in conjunction with other groups that impact the work conducted by the clinical operations staff. Driving the timely completion of SOP updates.
Identify training needs and organize training interventions to meet quality standards. Ensuring SOP curricula for roles within the group are current and accurate.
Develop, recommend and monitor corrective and preventive actions to ensure that quality issues are resolved and prevented in future through proactive and coordinated employee training and process innovation.
Plan and conduct audits related to clinical operations including, but not limited to, clinical vendor audits, study site Quality Assurance audits, electronic Trial Master File (eTMF) audits, and site and sponsor pre-inspection preparation. Document internal audits and other quality assurance activities. Prepare reports to communicate outcomes of quality activities.
Act as a catalyst for change and improvement in performance and quality across the group. Identify trends that could improve the quality of clinical studies and data collection processes.
Coordination, Communication, and Administration:
Manage and communicate functional, departmental or organizational initiatives.
Manage and identify training gaps within Clinical Affairs and data management functions, manage the development of training materials to meet that gap, and provides training as required to improve core competency and skill set of the department.
Manage and participate in quality and continuous improvement efforts to increase overall effectiveness of the Clinical Operations and data management teams.
EDUCATION: Bachelor’s Degree or equivalent combination of education/experience in math, science, LifeSciences, Pharmaceutical, or health related field required. Advanced degree is a plus.
JUUL LABS PERKS & BENEFITS:
A place to grow your career. We’ll help you set big goals - and exceed them
People. Work with talented, committed and supportive teammates
Equity and performance bonuses. Every employee is a stakeholder in our success
Boundless snacks and drinks
Cell phone subsidy, commuter benefits and discounts on JUUL products
Excellent medical, dental and vision benefits
Location. Work in the heart of San Francisco, one of the world’s greatest cities
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
Minimum of 2 years of progressively responsible experience in clinical quality assurance within a medical device, pharmaceutical, biotechnology, CRO, and/or healthcare setting required.
Minimum of 5 years clinical operations management/project management experience.
Previous experience establishing quality clinical programs is preferred.
Experience in design and development of quality plans and audit plans preferred.
Demonstrated analytical, negotiation, documentation, meeting management, and leadership skills are required.
Demonstrated knowledge of clinical quality assurance processes including, but not limited to, planning and conduct of site and vendor audits, Good Clinical Practices (GCP), Good Documentation Practices (GDP), and Quality Management Systems (QMS) is required.
Demonstrated ability to effectively interact with and collaborate at all levels in the organization and with external stakeholders, including effective interfaces at the senior management level.
Strong interpersonal, verbal and written communication skills.
Ability to form strong and constructive internal as well as external professional relationships.
Detail oriented, excellent organizational and management skills.
Must have the demonstrated core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan.
Thorough knowledge of FDA guidelines and regulations, ICH guidelines and Good Clinical Practices (GCP) governing the conduct of clinical trials required.
Ability to travel up to 20% of the time.
About JUUL Labs
JUUL's mission is to improve the lives of the world’s one billion adult smokers by driving innovation to eliminate cigarettes. JUUL is the number one US-based independent e-cigarette, selling over four million JUULpods per month. Headquartered in San Francisco and backed by leading technology investors including Tiger Global, Fidelity Investments and Tao Invest LLC, JUUL Labs is disrupting one of the world’s largest and oldest industries.We’re an exceptional team with backgrounds in technology, healthcare and biotech, and we’re growing rapidly to deliver on our mission. We’re actively looking to hire the world’s best scientists, engineers, designers, product managers, supply chain experts, customer service and business professionals.