Sr. Medical Writer - 19909

Sr. Medical Writer- Simply Biotech     

OVERVIEW     

Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.     

Immediate opening for a Sr. Medical Writer with a biopharmaceutical company in San Francisco, CA who possesses:      
        

• BS degree required with 6+ years of recent experience specializing in quality systems and risk management
• 10+ years of industry experience with quality systems management within biotech, pharma experience preferred, 
• Must be a SME for deviations, change control, developing CAPA's
• Experience with developing and implementing a new risk management system is a plus

Email resumes to hyazarlou@simplybiotech.com or call 858.496.7758    
        

FULL DESCRIPTION: Our client is seeking a highly motivated individual to join our team as Associate Director, Quality Systems. You will have the opportunity to create and ensure quality processes and systems are optimized and carried out appropriately to support GMP development and commercial activities for our first product launch!  You will lead various aspects of the Quality Systems, and ensure compliance with company's procedures, company policies, and regulatory guidelines.    

The selected candidate will be responsible for:    

• Design, develop and deploy quality systems in accordance with ICH Q10 model
• Ensure that quality systems are designed and operate as appropriate to provide support in development and commercialization for GXP areas
• Evaluate, identify, and drive continuous improvement opportunities within Quality Systems
• Assess Quality Management System processes for potential gaps to ensure compliance with regulatory guidelines
• Act as subject matter expert and provide guidance and training on quality events, including but not limited to change control, deviations, investigations, and CAPAs
• Establish and implement risk management program
• Own and drive completion of Quality Systems deviations, CAPAs, and change controls
• Lead quality governance board meetings, including deviation/CAPA, change control, and quality review boards
• Establish metrics and report out to management and cross-functional areas to ensure routine monitoring of quality system health
• Oversee and manage the electronic quality management system, including workflow configuration and upgrades, as needed
• Be the SME and represent Quality on cross-functional teams
• Participate in audits and inspections representing Quality Systems
• May supervise employees, consultants/contractors, and interns
• Other duties, as assigned by management

   
 The selected candidate will also possess:  

• Bachelor's degree in a scientific field, with 10+ years' experience in a biopharmaceutical, pharmaceutical, biologics, or related life sciences area and relevant Quality Systems experience
• Knowledge of GXP regulations and guidelines, as it pertains to Quality Systems
• Ability to work with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple
• Ability to work effectively with various technical groups and a strong working knowledge in the following disciplines: API or DP manufacturing, analytical development/QC
• Ability to work in a collaborative team environment is essential, with a customer-focused approach
• Strong decision maker with the ability to utilize critical thinking to problem-solve
• Must have strong interpersonal and communication skills
• Experience writing, reviewing and editing SOPs, as well as other document types

 
Salary Range: $190-$235k/yr         
For immediate and confidential consideration, please email your resume to hyazarlou@simplybiotech.com or call 858.496.7758. More information can be found at www.simplybiotech.com