Compliance Manager

$124,800 - $166,400/Yr

Actalent - Billerica, MA

posted about 1 month ago

Full-time - Mid Level
Billerica, MA
Administrative and Support Services

About the position

The Compliance Manager at Actalent is responsible for leading the training program strategy and implementation within a regulated pharmaceutical and biotech environment. This role involves developing and maintaining On-the-Job Training (OJT) programs, investigating quality issues, and ensuring compliance with GMP and GxP standards through effective training delivery.

Responsibilities

  • Lead the training program strategy, structure, and implementation.
  • Assist GMP and GXP work areas in developing, implementing, and maintaining On-the-Job Training (OJT) programs.
  • Investigate quality issues, determine root causes, and execute Training related CAPAs.
  • Design, develop, facilitate, and deliver general site and technical training content, including cGxP training.
  • Create instructional tools, hands-on exercises, and exams for training purposes.

Requirements

  • Bachelor's degree in a relevant field.
  • 10 years of relevant experience in pharma/biotech manufacturing or a similar regulated environment.
  • 5 years of experience leading training programs and delivering training.
  • Experience in developing and designing courses and training plans.
  • Knowledge of competency requirements in pharmaceutical and GMP cGxP regulated environments.
  • Working knowledge of pharmaceutical industry regulations and expectations.
  • Experience working with Trackwise.

Benefits

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Paid time off
  • Vision insurance
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