Manager, Internal Process Audit

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

The Manager, Internal Process Audits is responsible for end-to-end GxP relevant audit activities that encompasses the internal systems and processes of the Daiichi Sankyo's GxP group.

Together with regional management teams plans, will support, conducts and reports internal systems and process audits across the organization as appropriate for the area of GxP audits assigned.

Responsibilities:

• Execute the audit program for internal systems as applicable for the area of GxP audits assigned in alignment with the Master Audit Schedule using a risk-based approach to ensure the Audit Plans are aligned with the company's strategy and objectives and adjust the plan as needed to support business functions and internal stakeholders to execute audits effectively.
• Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews systems and procedures.
• Ensure trending and signal detection is communicated to stakeholders for risk mitigation.
• Support the stakeholders in identifying and defining quality improvement initiatives for development activities / programs post internal system audit.
• Support reporting of quality metrics for audits and inspections and execute against these metrics consistently.
• Provide inspection management support regarding compliance concerns identified during internal systems audits, remediations implemented and CAPAs pending.
• Support Risk Mitigation programs to ensure compliance to regulatory guidelines
• Ensure up to date audit CAPA information in the eQMS in a timely manner.
• Collaborate with QMS Team and applicable QA function to ensure no overdue CAPAs.

Qualifications : Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education:

• Must have a BS degree in a scientific discipline.

Experience Requirements:

• Must have at least 6+ years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance
• Must have proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials. Ability to provide interpretation and guidance for internal and external customers on GxP related regulations / guidelines (e.g., FDA, EU, ICH) and company procedures and policies.

Competencies:

• Professional or other related function and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products
• Proven experience with Health Authority Inspections, (e.g., FDA, HPFB, MHRA and other European regulatory agencies
• International experience is a plus; but at minimum experience working with diverse cultures and employees
• Expertise working within early development through Phase III and Pharmacovigilance studies preferred

Travel:

• Must have the ability to travel up to 15% domestic and international

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range:
$116,400.00 - $174,600.00

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