[Global] Manager for Clinical and Pharmacovigilance Quality

Job’s mission

As a Quality Assurance Manager, your primary responsibility will be to assist with Clinical quality and Pharmacovigilance/Safety vigilance—quality processes oversight in Santen SAS, EMA, and APAC regions. Your work will directly contribute to the success of our clinical development projects, products, and programs, helping us meet our aggressive and important goals. The position reports to the Head of Global Clinical and PV/Safety Vigilance Quality.

Key Responsibilities & Accountabilities

Following the General Company Policy and Principles on Quality, the primary purpose of the QA Manager role is:

Clinical Quality/Good Clinical Practice (GCP) area:

• To assist with oversight of Quality and compliance with clinical development projects, products, and programs. Promote Quality culture throughout Santen. Help establish a culture that supports open dialogue and continuous company-wide improvement. Creating a culture that values and rewards critical thinking and open, proactive dialogue about what is critical to Quality for a particular study or development program, going beyond sole reliance on tools and checklists, is encouraged.
• To work in collaboration with the Clinical Department, Pharmacovigilance/Safety Vigilance EMEA, APAC, and other functional areas as needed on the implementation of the Santen Quality Management System to achieve a high level of current Quality and compliance to regulated activities, company standards, and expectations of regulatory authorities.
• To provide guidance to Clinical Operations, Data Management, clinical supply, and Drug Safety to develop their self-inspection activities (TMF review, investigator site visits, etc.) as appropriate.
• To support Clinical Operations with quality-related issues and provide guidance when necessary
• To ensure patient safety and rights in compliance with applicable regulations by providing continuous support to clinical teams during the project lifecycle.
• Assist with conducting study-specific eTMF audit for inspection readiness
• To implement and maintain the Quality Management System in the GCP area in accordance with the local and global requirements
• To develop, maintain, and follow up quality metrics for GCP in collaboration with Clinical
• Operations, Data Management, and Drug Safety to achieve high-quality data
• To develop and implement global clinical trials GCP audit plan using a risk-based approach To develop and implement GCP internal audit plan. 
• To conduct internal GCP audits as scheduled or to outsource them when time conflict occurs.
• To perform QA assessment of Contract Research Organizations and external service providers. Review service provider selection and management process documentation for completeness and advise management.
• To conduct and/or supervise qualified auditors in scheduling, conducting, reporting, and following up audits as planned. 
• To prepare and to deliver to stakeholder’s periodic reports based on metrics and quality trends To perform vendor and investigational site's audit oversight (plan, manage and document audits performed for Santen
• To ensure that deviations and incidents are properly identified, managed and timely escalated when required.
• Based on audits and document review to provide guidance in determining root causes and ensure that appropriate corrective and preventive actions are efficiently implemented in all major and critical audit findings
• To participate in all health authority inspections at Santen sites as part of the global QA team or as a single point of contact based on company regulations
• To conduct GCP training for R&D employees according to company policy or to support such training when outsourcing as needed.
• To ensure readiness for GCP and GPvP inspections. Prepare investigator sites for announced regulatory inspections.

Region: Primary EMA, and Secondary: APAC

Good Pharmacovigilance Practice (GPvP) area:

• To implement and maintain the Quality Management System in the GVP area in accordance with the local and global requirements.
• To develop quality metrics for GPvP in collaboration with Drug Safety.
• In connection with the above to prepare periodic reports based on metrics and quality trends (electronic AE reporting, signal management, electronic PSUR submissions, and PSMF update of certain parts).
• To ensure that the deficiencies identified are properly managed (to implement risk management and criticality evaluation, grading system)
• Based on audits and document reviews to provide guidance in determining root causes and ensure that appropriate corrective and preventive actions are implemented on all major and critical audit findings
• To develop and implement the GPvP internal audit plan.
• To perform GVP internal audit according to the internal audit plan or to outsource them when time conflict occurred
• To participate in all health authority inspections at Santen sites based on company regulations

Region: EMA

Global GCP/GVP activity:

• To participate in global quality working groups (such as QMS documents review, CAPA management, audit planning) and projects regarding GCP and GPvP
• To communicate quality aspects of Santen SAS work to internal (e.g. affiliates, employees) and external stakeholders (such as vendors).
• To 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
• Assist in Quality review of Development and implementation of Safety Management Plans between Santen and Drug Safety vendor(s)
• May lead in ensuring signal detection activities are carried out per Santen SOP.
• Oversee reconciliation of safety data with external teams (Drug Safety vendor, Biostatistics)
• Participate in internal audits and co-host global regulatory inspections, including FDA/EMA, etc. as a subject matter expert for specific Drug Safety and Pharmacovigilance topics and processes, as needed
• To support and oversight GCP activity in the US Inc. (e.g. co-auditing as needed)
• To assist with computer system validation, as needed.
  
  Region: Global -EMA & APAC

• Minimum of 10+ years' experience in Clinical Quality Assurance and/or GPvP Assurance.
• At minimum, bachelor’s degree in the scientific field or related healthcare provider (i.e., RN, Pharmacist PharmD). Advanced degree is a plus.
• Minimum Ten+ years' internal GCP QA and GVP audit experience.
• Excellent understanding and practical application of domestic and foreign regulations and requirements regarding GCP and GPvP.
• Demonstrated experience preparing for regulatory inspections required.
• Excellent technical knowledge of GCP QA, GPvP QA, and quality assurance techniques.
• Thorough knowledge and experience in audit report writing and follow-up.
• Ability to understand and critically evaluate technical documents and records.
• Demonstrated ability to understand and interpret complex scientific data and concepts and effectively communicate this information 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 operate effectively 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 software suite and other professionally relevant computer applications.
• Computer system validation experience preferred

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer.  We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Santen SA, the Netherlands Branch has an exclusive arrangement for recruitment services. External recruiting agencies are kindly requested not to contact us regarding the positions listed here.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.