Sr. Clinical QA Manager

Neurocrine Biosciences • San Diego, CA

70d • $145,600 - $211,150

About The Position

Responsible for driving and leading Clinical Quality Assurance (CQA) activities in support of research projects across multiple therapeutic areas for development and commercial products. Provides Quality Assurance ('QA') expertise, leadership and training to ensure adherence with applicable regulatory requirements and company policies/procedures.

Requirements

• BA/BS in life sciences or related discipline or RN and 8+ years of related industry experience, including 4 years in CQA in drug development environment is preferred
• Master's degree in life sciences or related discipline and 6+ years of similar experience noted above
• Expert knowledge of all Clinical Trial related FDA regulations and ICH Guidelines, and experience with international GCP regulations and guidelines is desired
• Experience with gene therapy clinical trials is preferred
• Demonstrated ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies
• Ability to identify and escalate problems and follow-through with the corrective actions
• Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation
• Anticipates business and industry issues; recommends relevant process improvements
• Demonstrates broad expertise or unique knowledge
• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent communication, problem-solving, analytical thinking skills
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management, strong project leadership skills

Nice To Haves

• Experience with gene therapy clinical trials

Responsibilities

• Serve as the CQA Lead for complex programs, including those requiring unblinded CQA roles
• Develop risk mitigation plans and strategies
• Monitor the regulatory status of clinical investigators as well as study/site/vendor issues for GCP risks and take action when necessary
• Provide guidance on remediation and corrective action plans to ensure all parts of the study are conducted properly and in compliance
• Lead site inspection preparation activities and review inspection findings and responses in conjunction with QA management
• Provide GCP training as needed, including Investigator Meeting training
• Work with (may lead) a multidisciplinary team to standardize clinical development activities within and across programs through preparation of SOPs and personnel training
• Proactively research, test and implement quality systems, processes and procedures within CQA area
• Develop and assess GCP metrics, conduct trend analyses of GCP quality system metrics for management reporting
• Partner with QA management to drive strategies to ensure compliance to regulations, guidelines and company SOPs across the organization
• Support all on-site regulatory inspection activities
• Lead, plan, conduct, and oversee GCP audits to ensure compliance with applicable GCP/regulatory requirements and guidelines
• Develop and lead the execution of audit plans for assigned programs in line with overall QA annual audit plans
• Maintain current and accurate audit records, including CQA audit schedules, files, and audit database/tracker
• Provide proactive audit status and metrics reports to management
• Other duties as assigned

Benefits

• Retirement savings plan (with company match)
• Paid vacation
• Holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees