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 biopharmaceutical company dedicated to bringing best-in-class critical care and hospital-based therapeutics to patients. Artisan’s strategy is to acquire late phase clinical or marketed drugs and develop them for markets with clear unmet medical needs.
Position Description:
Primary responsibilities include: assuming the lead in the development and implementation of a comprehensive quality management plan; establishing an outstanding unified global quality system for internal and external parties; serving as the lead quality representative for the assigned projects – generation, review and compilation of quality required reports. serve as lead on audits and potential agency inspections.
Responsibilities:
- Oversee the operations of all GMP and GLP activities globally while focusing on continuous process improvement
- Represent the quality organization in interactions with other functional units which include regulatory affairs, quality documentation systems, project management, manufacturing, etc.
- Implement, manage and oversee quality programs such as change control, process specifications, review and approval of batch records, labeling, GMP /GLP CAPAs etc
- Assist quality documentation systems with archival of quality documents such as 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 assuring that products manufactured are in compliance with cGMPs, including the US, EMEA , and ASEAN regulations.
- Assist Senior VP of Operations with the development and management of a comprehensive budget for quality operations and activities
- Assist Senior VP of Operations with external collaborators and scientific institutions/associations on quality issues
Requirements:
- Bachelor’s degree or equivalent
- 5-10 years “hands-on” experience in a quality organization, preferably within the pharmaceutical and/or biotechnology industries
- 3-5 years “hands-on” experience in managing quality groups (both internal and external)
- Ability to function effectively as a member of project teams while demonstrating superior leadership skills
- Extensive knowledge of QA, QC, Regulatory compliance and all quality systems, including “hands-on” auditing.
- Full understanding of the commercialization of products (drugs and biologics) - both in the U.S. and world-wide
- Demonstrated effectiveness in quality assurance and achieving compliance for FDA-regulated pharmaceutical products
- Quality control laboratory management is a plus
- Excellent oral, written communication and auditing skills; proven ability to work autonomously and manage effectively in a matrixed environment.
ART-123 is Artisan’s first product and is a novel, recombinant, soluble, human thrombomodulin currently in development for the treatment of DIC (disseminated intravascular coagulation) in sepsis. ART-123 uniquely targets both coagulation and systemic inflammatory pathways and holds great promise as a self-regulating treatment of DIC in sepsis. ART-123 received approval in 2008 by the MHLW in Japan for the treatment of DIC. Artisan is currently conducting a large Phase 2b study of ART-123 for DIC in sepsis globally. Approximately 1.8 million patients in the United States and Europe suffer from sepsis annually, with approximately 30 percent of them developing or are at risk of developing DIC. For those that do, prognosis is poor.
Artisan Pharma is a Drug Free Workplace and pre hire drug screening will be preformed.
