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McKesson logo
McKesson

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.

Senior Quality Engineer

QA EngineerQA EngineerOtherRemoteSeniorTeam 10,001+Since 1833H1B SponsorCompany SiteLinkedIn

Location

Texas

Posted

132 days ago

Salary

$109.5K - $182.5K / year

Seniority

Senior

Bachelor Degree9 yrs expEnglish

Job Description

Senior Quality Engineer

McKesson

• Oversee and manage temperature mapping activities across all DCs in the network ensuring all facilities are mapped, validated, and compliant with applicable standards and internal requirements. • Coordinate with third-party vendors and internal teams for execution and documentation of mapping protocols and reports. • Lead internal temperature mapping activities, including but not limited to writing and reviewing validation protocols, conducting temperature mapping, analyzing mapping data, documenting and assessing deviations, and preparing final reports and corrective actions. • Oversee a team and oversee development and maintenance of relevant SOPs, maintain a centralized status dashboard of environmental mapping across the network, support audits and inspections by providing documentation and evidence of environmental compliance. • Provides coaching, mentoring, and performance management to team members, fostering a culture of continuous improvement and innovation. • Champions talent development and succession planning within the team. • Collaborate cross-functionally with Facility Managers (FMs), EM, and Operations teams to ensure timely completion of mapping activities.

Job Requirements

  • Degree or equivalent experience
  • 9+ years of professional experience
  • 1+ years of supervisory and/or management experience
  • Bachelor's degree in engineering, Life Sciences, or a related field (master’s preferred)
  • 9+ years of experience in Engineering, Technical Services, or Quality roles, preferably in pharmaceutical, biotech, or food industries
  • 3+ years of experience with direct responsibility for overseeing and conducting temperature mapping
  • Strong knowledge of USP standards and validation protocols
  • Proven experience managing cross-functional projects and driving network-wide initiatives
  • Experience with SOP development and regulatory compliance.
  • Minimum of 5-7 years of progressive leadership experience, preferably within pharmaceutical or life sciences, with a focus on temperature monitoring.
  • Knowledge of FDA and other regulatory agencies.
  • Knowledge of wholesale distribution and/or pharmaceutical manufacturing.
  • Excellent written and verbal communication skills.
  • Strong analytical skills.

Benefits

  • Competitive compensation package
  • Annual bonus or long-term incentive opportunities

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