McKesson

Research Quality Manager

McKesson$95K — $115K *
US-AnywhereRemote in Tennessee, US
Healthcare
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree required, Master's Degree preferred
  • Minimum 3 years’ experience in Quality Assurance, Quality Management, or Quality Auditing in clinical research or life sciences
  • Expertise in GCP, FDA, and other relevant regulations in a risk-based environment

Responsibilities

  • Develop and maintain effective relationships with investigative sites and colleagues
  • Monitor and modify policies and procedures
  • Utilize quality tools to assess study operations
  • Prioritize quality indicators using a Risk-Based approach within QBD framework
  • Identify and report deficiencies to appropriate colleagues
  • Assist in the development and modification of process documents
  • Educate staff in quality improvement methods and industry trends

Benefits

  • Comprehensive benefits supporting physical, mental, and financial well-being
  • Total Rewards offerings tailored to diverse colleague needs
  • Additional compensation options such as annual bonuses or long-term incentives
Full Job Description
Our Research Quality Manager is responsible for implementing the quality assurance program, managing and performing consult/support visits at investigative sites, assisting with onsite external audits and inspections, and providing routine quality support for assigned investigative sites.

This is a remote position in the US; relocation assistance and visa sponsorship are not available.

Duties include but are not limited to:
  • Develops and maintains effective relationships with investigative sites and other SCRI departments and colleagues
  • Monitors and modifies policies and procedures
  • Utilizes quality tools that assess the quality indicators of study operations
  • Monitors quality indicators for all sites using Risk-Based approach and within framework of QBD - Quality by Design - and prioritizes quality indicators depending on severity/urgency
  • Identifies areas of deficiency in quality and reports those deficiencies to SC Directors and other appropriate colleagues
  • Assists the business in development and modification of process documents
  • Assists with preparation and hosting of external audits
  • Assists research staff in maintaining regulatory compliance
  • Performs process / focused audits (as needed) of research sites utilizing research audit tools to ensure quality and reports audit findings to the appropriate leadership.
  • Ensures timely and appropriate follow-up in areas of deficiency.
  • Communicates observations and deficiencies to the Site Director / Manager and study PI, as appropriate.
  • Assists sites with Root Cause analysis and responses to external audits and CAPAs.
  • Maintains records of audits and reports.
  • Communicates with monitors and auditors of clinical trials, as needed.
  • Educates staff in quality improvement methods and industry trends
  • Other duties as assigned


Qualifications needed
  • Bachelor's Degree required, Master's Degree preferred
  • Minimum 3 years' work experience in Quality Assurance, Quality Management, or Quality Auditing preferably in a clinical research, healthcare or life sciences field
  • Expertise in GCP, FDA and other applicable regulations in a risk-based environment

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI's research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S. Please click here to learn more about our research offerings.

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson's (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:

McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.

McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.

McKesson job postings are posted on our career site: careers.mckesson.com.

About McKesson

McKesson Corporation provides medicines, pharmaceutical supplies, information and care management products and services across the healthcare industry. The Company operates in two segments. The McKesson Distribution Solutions segment delivers ethical drugs, medical-surgical supplies and equipment and health and beauty care products throughout North America. This segment also provides specialty pharmaceutical solutions for biotech and pharmaceutical manufacturers, sells financial, operational and clinical solutions for pharmacies (retail, hospital, long-term care) and provides consulting, outsourcing and other services. The McKesson Technology Solutions segment delivers enterprise-wide clinical, patient care, financial, supply chain, strategic management and software solutions. In July 2011, the Company acquired Portico Systems from Safeguard Scientifics, Inc. On March 25, 2012, it acquired the independent banner and franchise businesses of Katz Group Canada Inc. McKesson Distribution Solutions delivers pharmaceuticals to retail pharmacies and institutional providers like hospitals and health systems. They operate pharmaceutical distribution centers across the country, serving customers in all 50 states. They also deliver a comprehensive offering of health care products, technology, equipment and related services to the alternate site market, including physician offices, surgery centers, long-term care facilities and home care businesses across the country. McKesson is currently the largest pharmaceutical distributor in North America. McKesson also operates McKesson Canada and has an equity holding in Nadro, a leading distributor in Mexico.

McKesson Careers

Join McKesson, a leading global healthcare company, and be part of a team that is redefining the future of healthcare. With a variety of job opportunities available, McKesson is the perfect place to advance your career, whether you're a seasoned professional or just starting out. Work You’ll Do At McKesson, we are committed to improving care in every setting—one product, one partner, one patient at a time. We’re seeking talented professionals to join our team and contribute to a culture of innovation, diversity, and leadership. Our employees are driven by a deep sense of purpose and a desire for continuous growth and improvement. Empower Your Future in Healthcare With positions ranging from internships to leadership roles, McKesson offers unparalleled employment opportunities to develop your skills and advance your career. Our commitment to diversity training ensures that all team members have the opportunity to thrive. Join a team where your skills will be honed, your professional growth will be supported, and where you can genuinely see the difference you make in the lives of patients around the world. Innovative Work Environment McKesson is at the forefront of healthcare innovation. Our team is constantly exploring new ways to improve patient outcomes and streamline care processes. This commitment to innovation is what sets us apart and what makes McKesson an exciting place to work. Career Development and Benefits McKesson believes in nurturing the potential of its employees through robust career development programs and comprehensive benefits designed to support your life and well-being. From leadership training to health and wellness benefits, we ensure our team members are equipped to meet their professional and personal goals. Explore Job Opportunities Whether you’re looking for an internship to kickstart your career, or a senior position to utilize your extensive experience, McKesson offers a range of opportunities. Explore our open positions and find where you can make a difference at McKesson. Stay Connected Join Our Team Search for open positions that match your skills and interests. We are looking for passionate, curious, and solution-driven team players who are ready to take the next step in their careers. Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Networking and Professional Growth At McKesson, networking and professional growth are part of our everyday environment. We encourage our employees to connect, share, and learn from each other to foster personal and professional development. Job Alert Emails Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await you at McKesson. Join McKesson today and be part of a team that is dedicated to shaping the future of healthcare.
Learn more about McKesson
Size
58,000 employees
Market Cap
$53.7 billion
Industry
Net Income
-$4.1 billion
Founded
1833
5 Year Trend
+5.9%
Revenue
$237.6 billion
NASDAQ

Similar Jobs

More Jobs at McKesson

More Healthcare Jobs

Find similar Research Quality Manager jobs: