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Contact Info
Karen Shiel
Life Science

+353 1 5079256
[email protected]
Connect with me on
VP of R&D
Galway
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Dublin
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Republic of Ireland
Program Manager
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Details

Director, Quality & Compliance (GCP)


Reference:KS/AYJO-360448 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Our client is a global Biopharma organisation who play a crucial role in developing life-saving therapies. They are seeking a Clinical Quality and Compliance Director who is ready to dive-in to support our clients clinical development programs. As a Clinical Quality and Compliance Director, you will support and work with our clinical study management teams and teammates across R&D Quality and Compliance.

They need someone with strong leadership skills, expert Good Clinical Practice (GCP) knowledge, audit skills, communication, facilitation skills, and the ability to manage multiple projects. The successful person shall be a part of an expert and supportive team that fosters constructive collaboration in support of our clients clinical development programs.

You will be a part of an expert team supporting global clinical development programs, with a special emphasis on pediatric trials, based in our clients new location in Dublin, Ireland.

Role/ Responsibilities

  • Active member of the R&D Quality and Compliance Clinical management team
  • Lead Clinical Compliance activities and compliance staff in one or more therapeutic areas. Handle multiple projects and ensure overall and timely completion of tasks.
  • Works closely with compliance staff and clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
  • Support deviation identification, reporting, and CAPA development
  • Responsible for ensuring the development of audit strategy plan(s) and ensuring timely execution of plans for programs.
  • Oversees GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors.
  • Represent Regulatory Compliance in Working Groups as appropriate
  • Supervise, develop, train and manage internal staff as appropriate.
  • Ensure oversight of contracts auditors.
  • Effective compliance reporting to senior management and relevant quality governance forums
  • Leads intra/inter-departmental teams and/or projects that support continuous improvement of the Quality Management System. Builds positive support and acts as role model for change.
  • May lead/support management of regulatory inspection activities such as readiness preparation, inspection management, and/or response management.
  • Leads intra or interdepartmental teams of an operational nature such as preparing the Company for minor changes in regulations, continuous improvement initiatives.
  • Fosters a commitment to quality in individuals and a culture of quality within the organization.

Qualification/ Experience:

  • BSc/ BA and 8-10 years experience in clinical trials from a CRO or Biopharma
  • Must have significant GCP audit and compliance experience. Clinical Quality Assurance/Compliance experience required. Bio-pharma sponsor or CRO experience required.
  • Significant experience with pediatric clinical trials strongly preferred.
  • Recognized as an expert resource on a range of clinical compliance topics.
  • Strong verbal and written communication skills and interpersonal skills.
  • Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
  • Excellent organization skills and project management.
  • Able to work equally well as part of a team or independently
  • Ability to travel approximately 25% required.

For further details please call Karen Shiel on 087 7452487 for a confidential discussion or send CV to [email protected]