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Associate Director, Quality Business Partner, R&D Quality

2 months ago

Reston, Virginia, United States Net2Source Inc. Full time

Job Summary:

We are seeking a highly experienced Associate Director, Quality Business Partner, R&D to join our team at Net2Source Inc. as a key member of our R&D Quality organization. The successful candidate will be responsible for providing strategic, expert advice and consultation on R&D quality, risk, and continuous improvement with impact across cross-functional Good Clinical Practices (GCP).

Key Responsibilities:

  • Act as the R&D Quality Business Partner to assigned groups, such as Client R&D functions or vendors supporting Client R&D.
  • Provide expert advice and consultation on R&D quality, risk, and continuous improvement with impact across cross-functional Good Clinical Practices (GCP).
  • Educate assigned groups on Client quality policy and procedural standards, GCP regulations, and other requirements.
  • Provide expert advice on GCP risk minimization and mitigation.
  • Help the business understand potential impacts of risk and alternatives to best address risk.
  • Provide leadership support in escalating quality risks or issues.
  • Participate in Quality forums, cross-functional teams, and/or projects.
  • Act as the central point of contact for QMS-related communications to assigned groups; consolidating and channeling just-in-time information and resources to assist assigned groups.
  • Collaborate with other R&D Quality groups to ensure just-in-time support and resources to assigned groups, including data, reporting, training, audit, inspection, risk assessment, and deviation/CAPA management support.
  • May support Client during regulatory inspections.

Requirements:

  • PharmD/PhD with 2+ years' experience.
  • MA/MS/MBA with 8+ years' relevant experience.
  • BA/BS with 10+ years' relevant experience.
  • Significant experience advising business functions in the biopharma industry on GCP quality and compliance requirements, evolving regulations, risk minimization, and mitigation, and continuous improvement.
  • Previous GCP quality experience at a Sponsor or CRO; Previous experience as an auditor highly desired.
  • Experience working across a broad spectrum of quality and/or compliance activities, including authoring and reviewing SOPs, conducting internal auditing, supporting regulatory inspections, developing and managing CAPAs and deviations, and training others on quality and/or compliance requirements.
  • Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials, or other drug development activities.
  • Experience working with total quality management methodologies, such as Lean Six Sigma, is a plus.

Preferred Qualifications:

  • Thorough knowledge of standards, systems, policies, and procedures that enable Good Clinical Practices (GCP), QMS operations, and compliance within the biopharma industry. Experience with Good Clinical Laboratory Practices (GCLP), Good Pharmacovigilance (GVP), and Electronic Systems Compliance (ESC) is a plus.
  • Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
  • Demonstrates advanced business knowledge and analytical skills, as evidenced by strengths in assessing complex systems and data and understanding the quality and compliance implications.
  • Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects, and/or initiatives.
  • Strong interpersonal skills and understanding of team dynamics.
  • Strong communication and organizational skills.
  • Strong negotiation and conflict resolution skills.