Clinical Quality Assurance Director - 17672

Clinical Quality Assurance Director- 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 Clinical Quality Assurance Director in S. San Francisco, CA who possesses:    

• 7+ years of Quality Systems experience in a pharmaceutical environment 
• Extensive experience with worldwide GCP regulatory requirements, Developing GCP systems, doing inspections, setting up SOPs 
• Experience overseeing clinical trials Phase I-III 
• Bachelor's degree in a scientific or technical discipline is required. 
• Management experience of personnel and functions
• Must have experience with GCP, GVP and GLP.

Full Job Description: The successful candidate will work cross-functionally to develop and implement quality systems and processes to meet all US, EU and global requirements. The position involves managing and participating in global Clinical Quality operations and liaison of Clinical Quality related issues with the company's related functional department. The candidate must have experience reviewing and collaborating on regulatory submissions as well as hosting and facilitating regulatory inspections. The ideal candidate has a quality mindset in global clinical development and oversees Clinical Quality activities including but not limited to inspection readiness, and internal and external audits with a proven ability to manage multiple complex projects. You will lead, execute and manage Clinical QA activities while being an advocate to drive a quality and regulatory compliance culture. 

The selected candidate will also possess: 

• Develop and implement GCP, GLP quality systems in accordance with ICH, FDA, EMA and global competent authority regulations and industry guidance 
• Provide CQA oversight to Phase I-III global clinical studies to ensure study conduct compliance in accordance with GCP, applicable regulatory requirements, study protocols and procedures 
• Oversee and manage the auditing and qualification process for clinical trial vendors, suppliers and contract organizations and facilities and internal departments 
• Lead and ensure inspection readiness activities for all internal and external entities 
• Lead and host GCP, GVP, GLP inspections. Follow up to any responses and CAPAs 
• Conducts audits at clinical trial sites and Contract Research Organizations to ensure compliant conduct of sponsored clinical trials 
• Develop, implement and manage the deviation and CAPA systems 
• Responsible for writing and maintaining GCP SOPs and providing associated training 
• Accountable for the QA review of clinical trial documentation and documents submitted to regulatory agencies 
• Develop and implement overall GCP strategy, performance metrics, analytics and reports 
• Continually evaluate systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards 
• Represent Clinical QA on assigned projects and study/program team meetings to anticipate and address quality issues that may arise, including identification and resolution. Be an advocate for quality and regulatory compliance 
• Build positive professional relationships and trust with team members, colleagues, external contractors, vendors, consultants, and regulatory authority contacts 
• Participate in the recruitment, performance, and management of staff in Clinical QA, including coaching, career development and oversight of work 
• Effectively communicate compliance related metrics, risks, and compliance challenges to senior management 
• Support continuous improvement planning 
• Communicate and promote a culture of quality and regulatory excellence  
• Up to 10-15% travel may be required 
• Other duties as assigned 

The selected candidate will also possess: 

• Experience with electronic Quality Management Systems and Trial Master File 
• Experience in developing and maintaining QA systems 
• Experience working with CROs 
• Develop teams to engage collaboratively and constructively 
• Experience leading/hosting US and international health authority inspections/interactions 
• Experience in crafting and implementing quality systems and risk management tools 
• Ability to critically evaluate and troubleshoot complex problems and attention to detail 
• Experience managing direct reports, including coaching and career development 
• Strong teamwork, collaboration and management skills 
• Ability to deliver in a fast-paced, small company environment and tenacity to seamlessly adjust workload based upon changing priorities 
• Ability and desire to multitask and function in a fast-paced entrepreneurial environment 
• Highly responsible, self-motivated professional with enthusiasm and passion for the work 
• Sense of urgency in performance of duties 
• Highly proficient with various Microsoft and other computerized systems (Word, Outlook, Excel, PowerPoint, Visio, Veeva, Audit Utopia etc) 
• Interpersonal skills that promote a collaborative and productive environment 
• Effective and efficient written and oral communication skills 

Salary Range: $168k-$213k/yr 

For immediate and confidential consideration, please email your resume to kchaney@simplybiotech.com or call 858.427.0687

More information can be found at www.simplybiotech.com