Manager, Internal Process Audits

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

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, supports, 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 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

Education Qualifications
Bachelor's Degree in a scientific, healthcare or related discipline required

Experience Qualifications
4 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance 
Must have strong 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. 
Professional or other related function and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products strongly preferred
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 is required
Demonstrated expertise working within early development through Phase III and Pharmacovigilance studies

Travel Requirements
Ability to travel up to 10% of the time. 15% domestic and international travel

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:

USD$116,400.00 - USD$174,600.00