Manager, Quality - North America

at

Ergomed

Raleigh, NC
Full Time
2mo ago

Company Description

Founded in 1997, Ergomed Plc is a CRO dedicated to the development of new drugs to save or improve lives. Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.  Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for complex trials in Rare Diseases, Oncology and Neuroscience.

Job Description

The Manager, Quality – North America (NA) is responsible for assisting in the development, coordination, and implementation of Good Clinical Practice (GCP) quality assurance activities.  This role performs, manages, and oversees all aspects of the QA audits program, while promoting a GCP-compliant operating environment and ensuring continuous improvement of the Quality Management System (QMS).  The Manager, Quality – NA is a resourceful, decisive self-starter with excellent customer service skills who can set goals, shift priorities, and work collaboratively to ensure regulatory compliance, risk mitigation, continuous improvement, and high-quality results.

  • Collaborates with the Director, Quality - NA to manage the development, execution, and maintenance of risk-based GCP audit activities to provide assurance that clinical trials are conducted according to the ICH GCP guidelines, governing regulations, and policies and procedures.
  • Develops, publishes, and maintains the Master Audit Schedule and the Internal Audit Schedule to ensure that audit-related activities are appropriately planned, resourced, and scheduled throughout the year.
  • Plans, prepares, and conducts internal, vendor, and other audits to ensure quality and compliance of GxP activities, systems, and services.  Generates audit reports, providing follow-up communication of results to relevant stakeholders for decision-making and continuous process improvement.
  • Working to strict deadlines, participates in the scheduling, planning, hosting, follow-up, and closure of sponsor audits and assessments to support client’s evaluation of CRO quality and compliance.
  • Ensures that relevant audit findings are incorporated within the CAPA program to support continuous QMS improvement, while overseeing the tracking and trending of issues (i.e., CAPAs and Deviations).
  • Assists with the creation, revision, management, and harmonization of processes and procedures, as well as reviewing and providing input on cross-functional processes and procedures, to maintain quality and ensure regulatory compliance.
  • May be responsible for training new and existing employees; planning, assigning, and directing work; removing obstacles/roadblocks that hinder staff progress; guiding/motivating junior-level employees; and authoring/discussing performance appraisals.

Additional Responsibilities

  • Advise/coach/train staff, when needed, to ensure compliance with internal and external policies, laws, and regulations.
  • When needed, provides departmental leadership and represents the Director, Quality - NA during his/her absence.
  • Works cross-functionally to assist with the completion of client questionnaires and development of RFI responses while adhering to strict deadlines.
  • Serves on committees and special projects as determined by the Director, Quality - NA.
  • Assists with the development and support of the inspection-readiness program to ensure that the organization is prepared to successfully host regulatory inspections.
  • When needed, assists with the recruitment, interviewing, selection, and hiring of talented, high-performing staff who are an exceptional fit within the QA department and the organization’s corporate culture.
  • Provides ad hoc support of corporate initiatives related to mergers and/or acquisitions.

Qualifications

  • Minimum requirement of a bachelor’s degree (or equivalent combination of training and experience).
  • Education in a scientific discipline.
  • At least 5 years of relevant QA experience.
  • GxP Auditing experience.
  • Evidence of increasing responsibility in the CRO / Biotech / Pharmaceutical Industry in a GCP quality role.
  • Strong working knowledge of regulatory requirements, GCP guidelines, and risk management principles with the ability to apply them in daily practice.
  • Excellent verbal and written communication skills (English - full professional), with the ability to produce documents and records independently or with minimal oversight.
  • Proficiency with IT systems, apps, software tools, search, and databases to retain, find, access, analyze, and present data/information in the most effective ways (e.g., for auditing, reporting, metrics, tracking, training, etc.).
  • Ability to prioritize work and manage multiple projects while maintaining quality.

Additional Information

  • Desired:  Experience with hosting Sponsor/Client audits.
  • All of your information will be kept confidential according to EEO guidelines.
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