Director, Clinical Quality Assurance

Eisai; Pennsylvania; Hybrid; USD 195.000 - 256.000; Vollzeit

Zusammenfassung

Eisai seeks a Director, Clinical Quality Assurance to lead the NA CQA strategy, audit and inspection management, and ensure programs comply with GCP, SOPs, and global regulations.

This role oversees audits of sites and vendors, mentors staff, and may manage teams; travel about 15% to support inspections and audits, with hybrid remote work options per policy.

Qualifikationen

• Bachelor's degree in a related discipline; advanced degree preferred.
• 12+ years in clinical research or operations; site monitoring experience preferred.
• 5+ years of experience in GCP auditing and inspection management.
• Strong knowledge of US/EU/international regulatory standards for clinical trials.
• Ability to influence senior stakeholders and maintain quality independence.

Aufgaben

• Independently conduct audits and oversee audits of sites, vendors, documents, and processes.
• Facilitate sponsor health authority inspections of global facilities and sites.
• Provide skill-building for CQA staff and potential people management.
• Maintain alignment with GCP, SOPs, and worldwide regulatory guidelines.

Kenntnisse

GCP auditing

Inspection management

Regulatory knowledge

Audits leadership

Stakeholder influence

Data integrity controls

Analytical skills

Report writing

Travel readiness

Ausbildung

Bachelor's degree in a related discipline

Advanced degree preferred

Tools

CSV (Computer System Validation)

Quality Management System

Jobbeschreibung

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference.If this is your profile, we want to hear from you.

Job Profile Summary

The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH).

Essential Functions

• Independently conduct audits
• Oversee and guide conduct of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits
• Facilitate Sponsor health authority inspections of global clinical facilities and study sites
• Provide skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies.
• Potential for direct people management.

Requirements

• Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research or operations or related area. Prior experience in site monitoring and study management is preferred.
• Strong knowledge of multiple therapeutic areas, eg. neuroscience and oncology, and ability to translate key protocol objectives into auditable activities
• 5+ years of experience in GCP auditing.
• Substantial experience in inspection management.
• Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials.
• Demonstrated ability to effectively influence and collaborate with senior stakeholders, maintaining Quality's independence and authority in challenging and high-pressure situations.
• Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
• Knowledge of data integrity controls and systems quality for clinical area
• Strong analytical skills and report writing skills
• Knowledge of GxP systems including computer system validation and associated regulations, recommended.
• Ability to Travel (approximately 15%)

Candidates near Eisai's NJ/PA location will be preferred. For candidates near an Eisai location, Remote Work Arrangement will consist of 2-4 days in office (Nutley/Exton) per month and 1-2 audits quarterly; remote audits, are held in Nutley. CQA is also expected to be present in Nutley for any inspections or critical inspection mgmt. activities.

Eisai Salary Transparency Language: The annual base salary range for the Director, Clinical Quality Assurance is from :$195,000-$256,000. Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan.Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits . Certain other benefits may be available for this position.

Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.

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