Sr Mgr Quality Systems - Military veterans preferred

The Senior Manager, Quality Systems will manage and maintain GxP compliant QMS processes and procedures to include Veeva eQMS, Veeva QualityDocs, Supplier Management, Product Complaints and associated QMS projects.

Roles & Responsibilities

1. Assist the Quality Systems team in maintaining current, compliant Quality System Processes
2. Quality Management System coordination and support to include Change Management, Product Complaints and Supplier Management
3. Manage various Quality System projects/project timelines to include annual product quality reviews
4. Manage Quality System metrics and reporting 
5. Work as part of the Quality Systems team to support the Veeva eQMS implementation project
6. Maintain and track quality activities/events/records and applicable quality documentation within the eQMS
7. Manage product complaints, coordinate product complaint investigations, supplier investigations, and associated CAPAs
8. Support the coordination and follow up of internal audits, and audit observations 
9. Support the coordination of Arcutis corrective and preventive actions (CAPA), deviation processes
10. Participate in supplier qualification activates, coordination of onboarding suppliers, coordination of supplier monitoring/assessments, maintenance of the Approved Supplier List
11. Support the organization and coordination of Regulatory Agency inspections
12. Other supportive roles/duties that may be assigned  

Education & Licenses and Experience

Bachelor’s degree preferred or at least 5 years of experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility. Minimum of 2 years of project management experience.

Competencies & Skills

• Knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
• Knowledge of GMP, SOPs and quality systems
• Strong knowledge/skills in project management
• Excellent writing, editing and document formatting skills
• Works on multiple assignments in collaboration with various cross-functional departments
• Advanced skills with MS Office applications Word, Excel, Access, as well as Adobe Acrobat and Smartsheet
• Knowledge of eQMS based applications
• Ability to work in a fast-paced, start-up environment
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
• Ability to work independently and as part of a team
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment

Why Join Us? 
   
Arcutis is a pioneering medical dermatology company dedicated to revolutionizing the treatment of serious skin diseases and our pipeline is one of the more robust and exciting in the industry. Our vision is to revitalize the standard of care for dermatological diseases and conditions through novel therapies that simplify disease management for physicians and patients. We are focused on filling the innovation gap in medical dermatology drug development by applying our deep clinical, product development and commercial expertise in dermatology to develop best-in-class therapies against biologically validated targets. Arcutis is uniquely positioned to become the preeminent innovation-driven medical dermatology company, and we are looking for top talent to join our team. We are nimble, collaborative, and passionate about achieving our mission!
  
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.

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