Job Posting for Director, Quality Assurance at Tempus
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-SH1
Salary.com Estimation for Director, Quality Assurance in Chicago, IL
$115,526 to $146,019
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
Sign up to receive alerts about other jobs with skills like those required for the Director, Quality Assurance.
Click the checkbox next to the jobs that you are interested in.
Batch Testing Skill
Income Estimation: $239,587 - $380,690
Hazard Analysis and Critical Control Points (HACCP) Skill