Job Description

1 Company’s Description Aesculape CRO is a global CRO with headquarters in Singapore, with offices in Belgium and Malaysia, and operations in other countries in Southeast Asia. We are providing full clinical trial services to the pharma and the CRO industry. We are experienced in coordinating multi-center and international trials and are specialized in oncology and metabolic trials. Aesculape has experience in managing and monitoring complex trials for a variety of studies including interventional procedures, medical devices, small molecule drugs, and in biosimilars.

2 The head/associate head of Clinical Quality Assurance (QA) will be responsible for all aspects of QA, and spearhead any Good Clinical Practices (GCP) related activities to ensure QA and compliance of sponsored clinical trials with applicable GCP regulations (e.g., FDA, country-specific regulators), ensure ICH GCP guidelines adherence, maintain, update and create when needed Standard Operating Procedures (SOPs), and enforce best practices and current industry standards. Activities will generally fall under the following areas: GCP QA audit program, quality systems, and internal/clinical study team support. The successful candidate will help improve and modernize the quality management system (QMS), will establish, maintain, and ensure effectiveness of quality programs and documentation to assure GCP compliance and inspection readiness.

3 Role & Responsibilities

• Work collaboratively with internal Clinical Operations Team to ensure compliance standards are achieved.

• Manage the QMS interface and support for all Project Teams.

• Identify and access compliance risk areas and develop and implement risk mitigation measures.

• Manage GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines.

• Review and approve SOPs

• Develop and Implement (GCP and other as may apply) SOPs, with the support of key stakeholders if applicable.

• Develop and Implement detailed audit plans and yearly GCP audit schedules.

• Ensure the timely and effective follow up of all identified or assigned quality issues.

• Conduct QA oversight of GCP protocols, ICFs, CSRs and other clinical trial specific documents as requested.

• Direct or perform CSR audits and eTMF audits.

• Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans.

• Direct and/or deliver yearly training (GCP, PV,…) for internal staff.

• Work closely with Clinical Development, Clinical Operations, Biometrics, PV/Safety and other departments to ensure compliance readiness.

• Provide leadership in inspection preparedness to clinical sites, GCP and GCLP vendors for BIMO inspections and inspections by other regulatory government agencies.

• Provide management reports on audit strategy, plans, findings, and product complaint trends.

• Support process improvement initiatives; Lead continuous process improvements within Quality.

• Maintain required knowledge of applicable regulations, guidelines and company standards and procedures.
  

4 Qualifications 4.1 Education, Certifications, Experience

• Bachelor’s Degree or advanced degree in a scientific discipline

• Quality assurance professional certification is a plus.

• Minimum of 2+ years’ current work experience doing QA in pharmaceutical/biomedical industry.

• Demonstrated Quality Management System experience (GCP specific QMS experience preferred).

• Demonstrated Issue Management and CAPA experience in a clinical environment.

• Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.

• Strong leadership with demonstrated ability to interface with senior leaders and different levels of organization.

• Comfortable working with IT system, in particular SharePoint

4.2 Knowledge, Skills, and Abilities

• Working experience and solid understanding of GCP and ICH clinical requirements.

• Excellent written/oral communication skills and interpersonal skills to build key networks and business relationships across all levels of the business.

• Attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents.

• A self-starter and a team-player with a can do attitude who thrives in a fast-paced dynamic team environment.

• Capacity and enthusiasm to learn new skills is a must.

• In-depth/advance knowledge of the following software is highly desireable:

o SharePoint o Microsoft Office applications (Word, Excel, PowerPoint) o eSigning Platforms (e.g. Adobe, or DocuSign,…)

• Experienced working with EDC, IRT, eTMF, EMR systems highly desirable
  

5 Other/Special Conditions

• Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and ability to lift up to 10 kg may be required. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Ability to travel up to 25% both domestic and internationally is required.

• Working from home or office as mandated by the business needs (and preference) of the successful candidate

• Location: Preferably in Singapore
  

6 How to apply Please follow the instructions below to submit your application successfully:

• Send an email to: recruitment@aesculape.com

• Use subject line: “ JobID: 0003_QA-Manager_Head,AssociateHead – Application from [Enter: Applicant Name] ”

NOTE: Feel free to apply even if the Job posting board where you found the advertisement indicates that the role is no longer accepting applications.