Careers

To apply for the position below, email your résumé to Lisa Byrne at careers@artisanpharma.net. Emails only, please.

 

Director, Quality

Artisan Pharma is a newly created biopharmaceutical company dedicated to bringing best-in-class critical care and hospital-based therapeutics to patients. Artisan’s strategy is to acquire clinical stage or marketed drugs and develop them for markets with clear unmet medical needs.

Position Description:

Primary responsibilities include being the lead in the development and implementation of a comprehensive quality management plan by establishing an outstanding unified Global Quality System for internal and external parties and serve as the lead Quality representative for the assigned projects; generation, review and compilation of Quality required reports and regulatory submissions.  This individual will also serve as lead on audits and potential Agency inspections.  This position will develop and implement initiatives aimed to ensure the successful and timely completion of the ART-123 Phase 2b clinical trials and all related clinical trial milestones.

Benchmark Standard:

Must have “hands on” experience in the development of, establishment of, and management of, and defending Quality systems both internally and externally. Must have extensive knowledge, understanding and proven application of Global Quality Compliance Regulations. Superb quality documentation generation skills and proven communication skills.

Responsibilities:

Oversee the operations of all GMP, GCP and GLP activities globally while focusing on continuous process improvement.
Represent the Quality organization in interactions with other functional units.  These include Regulatory Affairs, Clinical, Project management, Manufacturing, Finance, etc.
Establish, oversee, and manage documentation systems including but not limited to, change control, SOPs, protocols/reports.
Oversee the development of a global (internal and external) audit program as well as the development of a centralized system for the oversight of quality agreements.
Lead the implementation of a Quality System that will assure that products manufactured are in compliance with cGMPs, US and EMEA regulations, and clinical research carried out is in compliance with the GCPs.
Assist Sr. VP of Regulatory Affairs and Quality Compliance with the development and management of a comprehensive budget for Quality operations and activities.
Assist Sr VP of Regulatory Affairs and Quality Compliance in activities associated with liaison to external collaborators, and scientific institutions/associations on quality and regulatory issues.

 

Requirements:

Possess and demonstrated effectiveness in Quality Assurance and achieving compliance for FDA regulated pharmaceutical products as well as Quality Control Laboratory Management a must.
Extensive knowledge of QA, CQA, QC, Regulatory compliance and all Quality systems. Full understanding of the commercialization of products (drugs and biologics) - both in the US and Rest of the World
Ability to function effectively as a member of project teams with demonstration of superior leadership skills
3-5 years hands on experience in managing quality groups (both internal and external),
5-10 years hands on experience in a Quality organization within the pharmaceutical and/or biotechnology industries is preferred
Candidate should possess excellent oral and written communication skills, auditing skills, and proven ability to work autonomously and manage effectively in a matrixed environment.
Bachelor’s degree or equivalent.

ART-123 is a novel, recombinant, soluble, human thrombomodulin being developed for the treatment of DIC (disseminated intravascular coagulation) in sepsis and DVT (deep vein thrombosis). ART-123 uniquely targets both coagulation and systemic inflammatory pathways and holds great promise as a self-regulating treatment of DIC in sepsis. Phase 3 studies have been completed for ART-123 in Japan for DIC and the product recently filed a Japanese NDA. Artisan plans on initiating Phase 2b studies of ART-123 for DIC in sepsis in the US early next year. Approximately 1.8 million patients in the United States and Europe suffer from sepsis annually, with approximately 30 percent of them developing DIC. For those that do, prognosis is poor.

For more information, visit our website:  www.artisanpharma.net

Artisan Pharma is a Drug Free Workplace and pre hire drug screening will be preformed.