Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.The Director, Quality Assurance (QA) is responsible for the management and oversight of Tempus Compass’ Quality Management System (QMS) and QA program.
This role is responsible for assessing Tempus Compass’ systems to ensure the organization operates in accordance with the standards of ICH-GCP and applicable GCP regulations.
Job Responsibilities:
- Collaborate with Executive Management to implement and improve the QMS for Tempus Compass, establish quality goals and initiatives, and ensure regulatory compliance.
- Oversee the QA audit program, including development and maintenance of the internal and vendor audit schedule and approved vendor list.
- Oversee and host client qualification, routine, and ad hoc audits.
- Manage and conduct qualification and ongoing audits of vendors and partners that have been contracted for clinical trial activities to assess adherence to applicable regulations.
- Conduct audits including Internal, Investigator Site and Trial Master File.
- Assist with the management of the document control process including review and approval of Tempus Compass controlled documents.
- Oversee the Tempus Compass CAPA and non-conformance programs.
- Provide Executive Management trends of the Tempus Compass QA program and CAPA status, at a minimum of annually.
- Support concurrent operational efforts by consulting on projects and representing QA in interactions with clients.
- Ensure standard procedures are updated to reflect technological changes, regulatory trends, and best practices.
- Host and support company regulatory GCP inspections.
- Assist with reports of suspected research misconduct investigation.
- Foster an environment that supports compliance and drive continuous improvement activities with emphasis on root cause analysis.
- Keeps current with regulatory surveillance & trends and shares information with applicable Tempus Compass personnel.
- Performs other duties as assigned
Demonstration of Tempus Compass Values:
Consistently strives to demonstrate the following Tempus Compass values:
- Recognizes that the team is always stronger than the individual
- Seeks to inspire others by demonstrating consistently strong performance
- Treats people with respect regardless of role or point of view
- Listens well and seek to understand before reacting
- Provides candid, helpful and timely feedback to colleagues
- Demonstrates curiosity about and contributes effectively to areas outside of their specialty
- Keeps the bigger picture in mind when making decisions
- Never stops learning
- Questions assumptions and offers suggestions for improvement
- Focuses on results rather than process and seeks to minimize complexity when process is required
- Identifies and addresses root causes, not symptoms
- Demonstrates poise in stressful situations
- Strives to always do the right thing
- Questions actions that are incongruent with Compass values
Minimum Qualifications:
- University/college degree (life science preferred) in a scientific or technical discipline from an appropriately accredited institution
- A minimum of ten (10) years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience
- Oncology clinical trials or oncology clinical experience
- Extensive knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
- Demonstrated ability to build rapport with team members and clients
- Excellent written and verbal communication skills
- Excellent organization skills, attention to detail and ability to handle multiple competing and changing priorities within tight timelines
- Able to proactively anticipate needs and follow through on all assigned tasks
- Proficient in Microsoft Word and Excel
Preferred Qualifications:
- 5 years of experience in a Leadership role at a CRO, biotech or pharma company
- 10 years of previous related GCP QA experience at a CRO, biotech or pharma company
- Prior experience working for both a Sponsor company and a CRO
- Early phase clinical trial experience
#LI-SH1We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
