Sr. Manager, Quality and Research Systems

07 May 2024

Vacancy expired!

Senior Manager, Research and Quality Systems AdministrationFull TimeWoburn, MA (Hybrid)

Principle Responsibilities:
  • Serve as the principal IT business partner and systems engineer in support of Development and Quality functions.
  • Manage enterprise Quality Control and Quality Assurance applications (QMS, Document Management, LIMS, ELN, etc.).
  • Provide support and applications management for standalone laboratory instruments in support of both our Development and QC Laboratories.
  • Guide and support computer systems compliance activities including change control and Computer Systems Validation (CSV).
  • Act as an internal advisor to align processes and systems capabilities with industry best practices.
  • Partner with stakeholders in the Development and Quality organizations to prioritize demand and the laboratory systems and Quality Assurance roadmaps.
  • Propose innovative technology and processes based on cost-benefit analysis and the need to address key capabilities gaps.
  • Moderate travel (estimated 10%) to laboratories in Woburn, MA and Overland Park, Kansas.

Required Educations, Skills, and Experience:
  • Bachelor's degree or above, with preference for majors relating to chemistry, quality management, computer science or similar fields of study.
  • At least three (3) years of relevant experience in the pharmaceuticals or life science industry, to include systems support of Research and Quality organizations with hands-on laboratory instrumentation experience.
  • Working knowledge of GLP and GDP, including Computer Systems Validation (Part 11, Data Integrity, Predicate Rule).
  • Prior hands-on experience with at least one of the following: LIMS implementation, QMS implementation, calibration management implementation, or ELN implementation.
  • Demonstrated business communications, influencing, and situational awareness skills.
  • Innovative and proactive mindset.
  • Ability to translate complex business problems into solutions.
  • Flexibility to wear several hats, ranging from strategy to hands-on systems work as needed.
  • Business process design and documentation skills.

Preferred Skills and Experience:
  • Prior experience working in a lean IT organization where each person must apply diverse skills and take responsibility for multiple processes and systems.
  • Direct experience with the following platforms: Agilent, Empower, and TrackWise QMS.
  • Direct hands-on experience with standalone laboratory instrumentation systems (i.e., Mass Spec, FTIR, Plate Readers, etc.)
  • Working knowledge of IT network engineering and information security principles; preference given to those with related education and certifications.
  • Six Sigma Blackbelt
  • Other certifications relevant to this role.

  • ID: #49879852
  • State: Massachusetts Woburn 01801 Woburn USA
  • City: Woburn
  • Salary: $140,000 - $160,000
  • Job type: Permanent
  • Showed: 2023-05-07
  • Deadline: 2023-06-16
  • Category: Et cetera