Covance Senior Manager, Regional Quality Control in China

Job Description:

  • Responsibility for the oversight of QC activities relating to GCP Compliance and Quality Management (QM) within their countries and in global alignment. This includes (but is not limited to), ensuring adherence and compliance with the process, identification and escalation of quality issues and monitoring the creation and execution of preventative and corrective action plans

  • Use of an annual quality plan including a process to collect, analyse and report on quality metrics across the regional business

  • In co-operation with other regional QA Managers and Senior Management, ensure the collection of appropriate metrics and tracking systems to facilitate a proactive, risk based quality management approach.

  • Co-Chair the regional ‘Quality Steering Committee’, reporting to the Quality Council – GLT (QC-GLT).

  • Communicate the business case to support recommendations for change to current business practices and processes

  • Project specific, Quality Control checklists using: SOPs and Work Instructions used for the project, Adverse Event Reporting Plan (AERP), Data Management Plan, Monitoring Plan, Project Management Communications Plan, and Statistical Analysis Plan as project specific templates to evaluate operations personnel compliance with the transfer of obligations defined by the project contract, and if required, the Master Services Agreement

  • Partner with Senior Management, Global QA & Compliance, Country Leadership, Functional and project leadership in identifying and prioritising opportunities/needs to improve quality throughout the region

  • Conduct quality review ‘deep dives’ with Functional Management, Senior Directors and Project Leads to identify quality issues, perform root cause analysis and deliver ‘lessons learned’ action plans to prevent recurrence of violations

  • Work with Operational and QA personnel to ensure completion and resolution of Client and Quality Assurance audit findings, Corrective Action and Preventive Action (CAPA) plans, and Corrective Action Issue Resolution (CAIRs) reports and to track these findings during other quality management evaluations to ensure that identical findings do not occur again on other projects

  • Ensure effective communication of quality control strategies, policies and procedures in conjunction with leadership teams

  • In conjunction with QA, partner LPC to define and execute appropriate training interventions

  • In conjunction with QA, identify, prioritise, communicate root cause of quality issues and facilitate the creation and execution of appropriate corrective action plans

  • Be available as required for all client and Regulatory audits/inspections

Requisition ID: 67869BR

Job Category: Clinical Research

Locations: China - Beijing, China - Shanghai, China - Guangzhou, China – Dalian

Shift: 1

Job Postings: - Responsibility for the oversight of QC activities relating to GCP Compliance and Quality Management (QM) within their countries and in global alignment. This includes (but is not limited to), ensuring adherence and compliance with the process, identification and escalation of quality issues and monitoring the creation and execution of preventative and corrective action plans

  • Use of an annual quality plan including a process to collect, analyse and report on quality metrics across the regional business

  • In co-operation with other regional QA Managers and Senior Management, ensure the collection of appropriate metrics and tracking systems to facilitate a proactive, risk based quality management approach.

  • Co-Chair the regional ‘Quality Steering Committee’, reporting to the Quality Council – GLT (QC-GLT).

  • Communicate the business case to support recommendations for change to current business practices and processes

  • Project specific, Quality Control checklists using: SOPs and Work Instructions used for the project, Adverse Event Reporting Plan (AERP), Data Management Plan, Monitoring Plan, Project Management Communications Plan, and Statistical Analysis Plan as project specific templates to evaluate operations personnel compliance with the transfer of obligations defined by the project contract, and if required, the Master Services Agreement

  • Partner with Senior Management, Global QA & Compliance, Country Leadership, Functional and project leadership in identifying and prioritising opportunities/needs to improve quality throughout the region

  • Conduct quality review ‘deep dives’ with Functional Management, Senior Directors and Project Leads to identify quality issues, perform root cause analysis and deliver ‘lessons learned’ action plans to prevent recurrence of violations

  • Work with Operational and QA personnel to ensure completion and resolution of Client and Quality Assurance audit findings, Corrective Action and Preventive Action (CAPA) plans, and Corrective Action Issue Resolution (CAIRs) reports and to track these findings during other quality management evaluations to ensure that identical findings do not occur again on other projects

  • Ensure effective communication of quality control strategies, policies and procedures in conjunction with leadership teams

  • In conjunction with QA, partner LPC to define and execute appropriate training interventions

  • In conjunction with QA, identify, prioritise, communicate root cause of quality issues and facilitate the creation and execution of appropriate corrective action plans

  • Be available as required for all client and Regulatory audits/inspections

Education/Qualifications: Required:

  • University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)

  • In lieu of this required educational background the following relevant work history may be considered:

o Minimum of three (3) years supervisory experience in a health care or clinical research setting and

o Minimum of six (6) years relevant clinical research experience in a pharmaceutical company/CRO

Preferred:

  • Masters or other advanced degree

Experience: Minimum Required:

  • Relevant clinical research experience in a pharmaceutical company or CRO

o Individual is proficient with on site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits)

o Minimum of eight (8) years relevant clinical research experience in a pharmaceutical company/CRO

o Thorough knowledge of drug development process

o Thorough knowledge of relevant SOPs, ICH, and GCP guidelines

o Project management, line management experience, and quality control experience highly desirable

  • Relevant quality management experience

o Detailed knowledge of all aspects of GCP guidelines and regulations

o Demonstrated ability to separate critical from non-critical GCP issues

o Demonstrated effectively balance quality and speed in complex situations

o Demonstrated ability to work in a team environment

o Demonstrated ability to work under pressure and requires minimal supervision

o Strong interpersonal and communication skills

o Strong analytical skills

o Excellent planning and organizational skills

o Excellent oral, written and presentation skills

EEO Statement:

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.