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Details

Senior Manager (Clinical Quality and Compliance)


Reference:KS/AYNO-802600 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Our client, a global leader in the Biopharma Sector & has an exceptional R&D Quality and Compliance team that fosters a phenomenal environment to develop your skills and expertise. Their strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by their diverse and expert team. They are a committed team of highly skilled Quality and Compliance professionals dedicated to helping deliver life-saving therapies for unmet needs. Their collaborative and supportive structure will help you develop your skills, experience, and your career.

They are currently seeking a Senior Manager (Clinical Quality and Compliance). The successful person shall be part of the Regulatory Compliance Division & will report to a Director, based in a new Centre of Excellence in Dublin. This person will require the drive to be ready to dive-in to support our client’s clinical development programs. You will support and work with their clinical study management teams and teammates across R&D Quality and Compliance.

They need someone with strong Good Clinical Practice (GCP) knowledge, audit skills, communication, and facilitation skills, and the ability to manage multiple projects. You will be a part of an expert team supporting global clinical development programs, with a special emphasis on Inflammation, Virology & global pediatric trials.

Role/Responsibilities:

  • Serve as Clinical Compliance Lead for assigned clinical trial programs in one or more therapeutic areas. Handle multiple projects and ensure overall and timely completion of tasks.
  • Leads development of audit strategy plan(s) and ensuring timely execution of plans for assigned projects/programs.
  • Provide training and oversight of contracts auditors.
  • Manages and/or leads GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors.
  • Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, escalates as appropriate, and support continuous improvement.
  • Support deviation identification, reporting, and CAPA development
  • Assists in readiness preparation, and/or directly support regulatory agency inspection. Assist in coordination of response to any findings.
  • Evaluate, write and/or review operating procedures (e.g., SOPs), and perform other activities in support of an integrated cross-functional quality management system (QMS).
  • Fosters a commitment to quality in individuals and a culture of quality within the organization.
Qualifications
  • BA or BSc and 4-5 years audit & compliance experience from a GCP perspective
  • Must have significant number of years GCP audit and compliance experience.
  • Bio-pharma sponsor or CRO experience required.
  • Experience with pediatric clinical trials preferred, but not essential.
  • 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%, as required.

For further details please contact: Karen Shiel at 087 745 2487 or send CV in confidence to karen.shiel@lifescience.ie