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21 CFR Program Manager

Hawkins Point Partners has an immediate need on its Cambridge Massachusetts team for a Senior Program Manager with expertise supporting Drug Research (R&D) FDA compliance applications. This person must experience supporting enterprise pharmaceutical (Drug Manufacturing) regulatory environments. Validated documentation process and program tracking skills required. This person will work with a team of tactical (hands on) project managers supporting a series of regulatory research efforts.  This person will craft the enterprise project execution strategy, thus expertise with FDA validated systems and the implementation process is required.   Experience with 21CFR Part II or related regulatory is a plus.

Core Skills:

  • Strategic Program Management skills supporting enterprise Drug Product Research and Development environments.
  • Strong technical (pharmaceutical systems acumen Experience working in clinical trials that are outsourced-CRO environments.
  • Enterprise project execution strategy and risk mitigation. Ability to mentor project managers and report at C level.
  • Support a quality process for FDA validated documentation-provide leadership facilitate daily audit preparation.
  • Validated documentation process and program tracking skills working in an 21 CFR Part II regulated environment.
  • Expertise supporting a range of regulatory systems.  This person will supervise a team of R&D project managers across the enterprise.
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