Associate Director Quality

Found in: Appcast US C2 - 2 weeks ago

Watertown, United States CSG Talent Full time

Our client is a clinical-stage biopharma company developing precision oncology medicines using its proprietary proteomics platform to develop drug-specific companion diagnostics. These diagnostics are used to identify patients whose tumours are predicted to be sensitive to specific medicines.

The role:

Our client is looking for an Associate Director of Quality to join their team in Massachusetts area, and play key role in the Quality and Compliance department and will have responsibilities for day-to-day management of the QMS, support of GxP functions, and will be key to the strategic and tactical evolution and success of the Quality and Compliance function.

Responsibilities:

  • Conducts GxP Compliance audits including development and execution of the annual audit plan.
  • Oversight of contract CMO and CRO vendors.
  • Responsible for training activities (including curriculum development) and SOP generation.
  • Monitor for emerging regulations and evaluating regulations for impact.
  • Contribute to development of key quality related compliance metrics including the generation of routine and ad hoc reports.
  • Participate in overall Departmental efforts to analyse internal metrics, identify, and characterize issues, determine root cause, and plan improvement activities.
  • Risk assessment and analysis.
  • Regularly leads multi-discipline projects as GxP or Compliance expert.
  • Supervises and provides guidance to unit colleagues beyond just a team/audit/project setting.
  • May mentor colleagues and be viewed as a GxP quality and compliance leader/mentor.

Requirements:

  • Minimum of B.S. in a scientific area
  • Minimum seven years of relevant GxP quality pharmaceutical/biotechnology experience
  • Academic and practical/working knowledge of at least two GxP disciplines with experience regarding the regulatory and compliance aspects associated with those disciplines. GxP disciplines in scope include GCP, CDx, CSV/IT, GLP, GMP, and PV.
  • Considers and incorporates required compliance, regulatory and quality perspectives, and requirements into daily and ad hoc work projects.
  • Express self clearly and accurately in written and verbal form.
  • Balances diplomacy and respectfulness with assertiveness.
  • Focuses on achieving objectives within specified timeframe and to meet quality expectations.
  • Ability to participate constructively on cross-functional and diverse teams.
  • Demonstrates negotiation and conflict management skills.
  • Ability to independently and effectively communicate audit / inspection scope and results to management of affected business units.
  • Engagement planning and management toward timely and quality completion of objectives.
  • Ability to lead cross functional and diverse teams and participate constructively in multi-discipline teams.
  • Position may require 10-15% domestic and international travel.

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