The Manager, Clinical Quality, is responsible for the designing, establishing, maintaining and executing a robust GCP and GVP compliance program, including conduct and oversight of audits, to ensure consistent adherence to relevant regulations, guidelines, company policies, strategies, procedures as well as contracts/agreements.
This position will establish and maintain strong relationships with internal and external stakeholders to ensure that quality standards are adhered to at all time and collaborate with global GCP and GVP QA members to ensure the initiation/completion of global initiatives.
In addition, this position will serve as the GCP subject matter expert on various clinical
development projects by providing high standard of quality guidance, advice and support on GCP regulatory compliance matters, and participate in and support health agency inspections as required.
DUTIES AND RESPONSIBILITIES
• Responsible for designing, setting up, maintaining and executing robust GCP and GVP compliance programs for both Local and Global GCP and GVP Audit Programs including proper management of audit schedules and execution of audits, ensuring compliance with regulatory standards, company policies, and procedures.
• Ensure the timeliness and completeness of reports and assessment of appropriate
• Serve as a subject matter expert by providing high standard of quality guidance, advice and support on GCP compliance
• Contribute to the development of local quality management systems, including contributing/writing policies/procedures.
• Partner with Quality Systems group to develop and enhance the GxP Quality
Management System, looking for cross-GxP efficiencies and synergies.
• Manage and identify potential systemic compliance risks including Investigations of
deviations and monitoring of corrective actions and preventative (CAPA)relating to
non- compliance issues and findings
• Manage and perform/handle GCP investigations regarding Quality Issues, Misconduct
Investigations including Serious Breaches etc.
• Establish and maintain GCP and GVP regulatory inspection readiness; Participate in
preparation and execution of health agency inspection activities.
• Support the development and delivery of GCP training programs.
• Lead development of process improvement strategies and tools related to GCP and
GVP compliance efforts.
• Assist with Clinical activities (e.g. deviations, CAPAs) when requested.
• Ensure key performance indicators for GCP and GVP are set-up, maintained, performed
and reported to detect and monitor any significant compliance deviations to the
company quality standards and/or regulatory requirements
• Maintain expert knowledge of regulations, company procedures, auditing, and quality
• Facilitate the sharing of best practices and help to drive continuous improvement and
• Continuously build and innovate in all aspects of GCP and GVP Compliance
• Perform other quality or compliance related duties as needed.
MINIMUM JOB REQUIREMENTS
• Bachelor’s degree in a scientific field required or relevant experience.
• Good understanding of GCP, knowledge of PMDA/EMA/FDA, ICH and applicable regulations
• Knowledgeable of basic statistics
• Proficient in Microsoft Office Applications (Excel, PowerPoint and Word)
• Ability to travel at least 10% of the time (International travel is required)
PREFERRED SKILLS AND EXPERIENCE
• Extensive knowledge and practical hands-on experience in GCP and applicable legislation
• Comprehensive understanding of pharmaceutical regulatory requirements and impact
on the various functions within the business
• Familiarity with database and GLP audit practices
• Ability to identify proactively and anticipate risk of non-compliance in a complex
• Ability to develop and manage efficient and effective compliance systems
• Excellent planning and organizational skills
• Ability to project manage, set clear strategic goals, align priorities and lead multiple
tasks/activities within a virtual/remote team to successful business conclusion
• Strong decision-making skills and ability to use independent judgment to quickly set
priorities, solve problems and resolve conflict
• Excellent oral and written communication skills and ability to adjust communication to
different target groups
• Good working knowledge and comprehension of written English and/or Japanese
• Exceptional attention to detail
• Inter-cultural awareness, proven ability to work in an international environment and
cross functional team
• Ability to work independently with minimal supervision.
• Ability to effectively multi-task, be proactive and self-motivate
• Ability to work to tight deadlines, with incomplete information, handle unexpected
events and work under the pressure
• Good analytical and judgment capabilities to understand/analyze/synthesis and
• Proven ability to influence senior leaders within the organization on matters of importance
• Customer-focused, good interpersonal skills, assertiveness, team spirit and coaching skills.
• Able to delegate but committed to providing proactive support to the business and
teams to achieve successful outcomes.
• A team player able to work with and through others; someone people proactively seek out for help, guidance and advice