Our client is seeking an experienced Quality Training Consultant to support a time-sensitive corporate initiative aimed at remediating systemic training deficiencies across multiple Quality System (QS) suites. This is a full-time 6-month role focused on conducting a comprehensive gap assessment of training curricula and establishing a robust governance model for ongoing maintenance and change control. This project can be completed while working , but it is a plus if the consultant is local and available to meet onsite as needed.

KEY QUALIFICATIONS:

• Strong background in Quality Systems training and compliance within regulated industries (Medical Device, Pharma, or Biotech preferred).
• ​​​​​​​7+ years of experience as a Quality Training SME supporting similar projects.
• BS degree minimum
• Demonstrated experience conducting training gap assessments and implementing governance for training programs.
• Familiarity with Learning Management Systems (Cornerstone experience is a big plus).
• Experience working with CAPA, NCR, and quality documentation systems.
• Excellent communication and stakeholder engagement skills; able to work cross-functionally.
• Ability to work independently and remotely while meeting aggressive deadlines.
  Job Types: Full-time, Contract

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Education:

• Bachelor’s (Preferred)

Experience:

• quality systems training/compliance in life sciences: 7 years (Preferred)
• conducting training gap assessments: 7 years (Preferred)
• implementing governance for training programs: 7 years (Preferred)
• LMS: 7 years (Preferred)
• Cornerstone: 5 years (Preferred)
• CAPA, NCR, and quality doc systems: 7 years (Preferred)

Work Location: Remot

• Conduct a comprehensive gap assessment of existing training curricula across ~36 Quality System suites (e.g., Training, Change Control, Document Control, Distribution & Warehousing).
• Collaborate closely with suite owners/SMEs to evaluate role-specific training needs for professional functions globally (e.g., R&D Engineers).
• Map out core, function-specific training curricula by role and procedure suite to ensure full training compliance and eliminate existing gaps.
• Help to design and implement a governance process for periodic review and change control of master curricula.
• May be asked to help establish a formal change management board/process to ensure training updates are properly reviewed, approved, and documented.