Quality Assurance Manager Good Clinical Practices

COMPANY DESCRIPTION

Santen is a specialized pharmaceutical company focused exclusively on ophthalmology in global markets around the world with more than 3,500 employees and sales in approximately 60 countries. Santen Inc., located in Emeryville, CA, contributes important ophthalmic research and development efforts worldwide and is home to our regional business teams. This office currently employs about 140 people and will grow by 50%+ in the near future.

With the passionate support of our Japanese parent company and its 125-year heritage, Santen is pursuing intellectually-challenging and stimulating work to deliver game-changing therapies that make hope a reality for people facing vision impairment and loss.

We are driven by and committed to our mission: Delivering Vision, Every Day. Additionally, our Corporate Strategy Policy for FY18-FY20 has provided essential focus for new commercialization efforts that will be fueled through an unprecedented increase in marketing investment and talent acquisition across Marketing, Sales, and R&D teams.

We are in search of top talent to help us meet our aggressive and important goals.

PRIMARY PURPOSE OF POSITION

This primary purpose of this position will be responsible for Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) oversight and for assuring the quality and compliance of Clinical Development projects, products and programs. Work in collaborations with Clinical Department and other functional areas as needed on the implementation of the Santen Quality Management System to achieve a high level of quality and compliance to regulated activities, company standards and expectations of regulatory authorities.

JOB DESCRIPTION

• Implement and maintain the Quality System in the areas of GCP and GPvP, in accordance with the local and global requirements.
• Develop quality metrics for GCP and GPvP in collaboration with Clinical Operations, Data Management, and Drug Safety. Prepare periodic reports based on metrics and quality trends.
• Ensure that deviations and incidents are properly managed and that escalation is performed when required.
• Provide guidance in determining root causes and ensure that appropriate corrective and preventive actions are implemented on all major and critical audit findings.
• Participate in all health authority inspections at Santen Inc.
• Conduct GCP training according to company policy
• Participate in global committees and projects regarding GCP and GPvP
• Keep abreast of regulatory requirements, and update local management on the possible ramifications of regulatory changes and impact to Clinical Development, Medical Affairs and Pharmacovigilance processes

MAJOR DUTIES OF POSITION:

• Develop and implement GCP audit plan for global clinical trials using a risk-based approach. Conduct and/or supervise qualified auditors in scheduling, conducting, reporting and follow up of audits as planned.
• Develop and implement GCP and GPvP internal audit plan. Conduct internal audits as scheduled.
• Perform QA assessment of Contract Research Organizations and external service providers. Review service provider selection and management process documentation for completeness and advise management.
• Assist with computer system validation, as needed.
• Ensure readiness for GCP and GPvP inspections. Prepare investigator sites for announced regulatory inspections.
• Provide guidance to Clinical Operations, Data Management and Drug Safety to develop their self-inspection activities (TMF review, investigator site visits, etc.) as appropriate. Support Clinical Operations with quality related issues and provide guidance when necessary

KNOWLEDGE AND SKILL REQUIREMENTS:

• Minimum of 8+ years experience in GCP Quality Assurance and/or GPvP Assurance.
• Bachelor's degree in scientific field, or related healthcare provider (i.e. RN). Advanced degree a plus.
• Minimum 8+ years' internal audit experience.
• Expert understanding and practical application of domestic and foreign regulations and requirements regarding GCP and GPvP.
• Computer system validation experience preferred
• Demonstrated experience preparing for regulatory inspections required.
• Expert technical knowledge of GCP QA, GPvP QA and quality assurance techniques.
• Thorough knowledge experience in audit report writing and follow up.
• Ability to understand and critically evaluate technical documents and records.
• Demonstrated ability to understand and to interpret complex scientific data and concepts and to communicate this information effectively to a wide variety of audiences.
• Strong interpersonal skills and the ability to work effectively in a cross-functional environment with a wide range of people to achieve results.
• Ability to effectively operate in an environment that requires collaboration, influencing skills, and analytical judgment.
• Excellent written/oral communication and presentation skills; demonstrated ability to write clear and concise text on highly technical topics.
• Strong analytical skills and attention to detail.
• Strong organizational, time management and project management skills.
• Proficient in the Microsoft Office® suite of software and other professionally relevant computer applications.

For more information about our company and the work experience, please visit www.santenusa.com