Quality Control and Training, Senior Manager

Clinical Development         ·          Beijing, China       ·           Full time 

Job Description

Title: Quality Control and Training, Senior Manager

Department: China Clinical Development

Reports to: Executive Director, Clinical Operation

Summary:

• Develop quality control mechanism and processes, as well as the implementation to support and impact the whole clinical operations for ensuring the clinical trial execution in compliance with ICH GCP, local regulations, and relevant Standard Operating Procedures (SOPs) through QC activities and training.
• Liaise cross-functional for QC and training support and implementation, and continuous improvement initiatives focused on quality and compliance. Coordinate and support the self-assessment and inspection readiness.

Duties And Responsibilities:

Quality Control Oversight

• Work with the study team to prepare the study QC plan, and perform the QC visit, TMF QC Check and other QC activities according to the QC plan
• Work closely with the study team and ClinOps to manage non-compliance and quality issues
• Develop or optimize the working procedures in clinical trial execution; monitor compliance risk and ensure mitigation/remediation actions are developed to mitigate risk for the assigned clinical trials or specific tasks
• Collaborate with internal/external stakeholders to facilitate audits and inspections as needed and support the related Corrective and Preventive Action (CAPA) preparation and implementation
• Provide mentoring or joint monitoring guidance to ensure training and executional excellence and effectiveness
• Contribute to cross-function initiatives or activities related to quality control, and serve as go-to person in clinical trial execution quality and compliance
• Contribute to develop quality and compliance related innovative tools or methodologies or process, such as design and development, evaluation and suggestions, implementation and enhancement
• Support the vendor assessment and oversight

Training and Consultation

• Participation and exposure in external quality workshop and build the relationship in the industry
• Design and implement the new study team member onboarding training program and update per request. Ensure the implementation within the required timeframe; Lead the orientation training related to job role for new hires in ClinOps
• Support the whole study team to complete the required trainings per company and function requirement, manage training record
• Lead and coordinate training programs across ClinOps and study team, e.g., best practice sharing, case study, lesson learnt, etc.
• Responsible to update and optimize the SOPs which ClinOps as the owner and support the other relevant SOPs development and revision
• Provide advice regarding SOPs, systems, GCP and other regulations questions
• Partnering with regulatory and QA teams to perform impact assessments of new/revised local regulations, guidance and standards and to share with the team
• Support local intelligence database as needed

Qualifications:

• Bachelor’s degree (advanced degree preferred), life sciences preferred or healthcare-related field;
• Minimum 5 years of experience in clinical trials of site management, study management or QC & training or equivalent, or 7 years proven experience and capability in clinical research and quality related function.
• Strong working knowledge of GCP guidelines, extensive knowledge in overall drug development process and clinical operations
• Expertise in regulatory requirements
• Well-developed skills and knowledge of business processes and practices (i.e., SOP, Governance, clinical trial activities)
• Solid ability to plan, organize, coordinate, manage and execute assigned tasks
• Experience in R&D process requirements to successfully drive QC productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis
• Experience in quality assurance (QA) activities preferred, including audits of clinical investigative sites, systems and vendors

Competencies:

• Problem Solving–Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Reasons when dealing with emotional issues.
• Interpersonal Skills–Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others’ ideas and tries new things.
• Communication–Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs.
• Leadership–Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
• Ethics–Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Strategic Thinking–Develops strategies to achieve organizational goals; Understands organization’s strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
• Judgment–Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Initiative–Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
• Innovation–Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others’ attention.

Please apply by sending your resume (.pdf format) to jobs@briibio.com.

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Brii Biosciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. We value diversity and are committed to creating an inclusive environment for team members from all backgrounds.

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