Quality Manager [China]

 

We’re on a mission to change the future of
clinical research. At Calyx, we help the

$ads={1}

biopharmaceutical industry bring medical
treatments to the market, faster.
Our mission is to change the world
but to do this, we need people like you.

Apart from job satisfaction, we can offer you:

YOURSELF

• Starting at 14 days holiday per year, rising to 22 days with increased service. In addition to public holidays
• Life Events, Service Awards, Company Outings

HEALTH

• Medical plan
• Annual medical check

WEALTH

• Social security and public housing fund
• Supplementary Housing Allowance
• Life assurance
• Critical illness cover

Key Accountabilities:

Review SOPs for Quality Excellence & Compliance

• Train & Advise internal stakeholders in creating & updating Standard Operating Procedures
• Review Standard Operating Procedure for adherence to regulatory and critical to quality criteria
• Maintain and safeguard the integrity of the quality management system as a whole
• Release Standard Operating Procedures and associated document
• Maintain an inventory of Standard Operating Procedures including its history

Provide Regulatory Expertise & Training

• Schedule and deliver regulatory training sessions
• Monitor for training compliance, up to date Curriculum Vitae and Job Descriptions
• Ensure that the organization has relevant regulatory expertise proven by personal and quality records

Review & Assess Suppliers

• Establish standards and critical to quality criteria for supplier evaluations
• Prepare assessment/audits plans for suppliers’ product/services
• Coordinate with supplier representative & internal stakeholders’ scope, timing and logistic of review/audit
• Conduct supplier audit/assessments following a risk-based approach
• Communicate & report on outcomes to management, internal stakeholders & supplier
• Oversee remediation plans provided by supplier in conjunction with internal stakeholders

Oversee and Consult on Quality of Service & Technology Deliverables

• Engage in clinical trial and technology projects to oversee deliverables for meeting critical to quality criteria
• Provides training, guidance, consultation and overall quality expertise in support of clinical trial and technology validation activities
• Oversee and support changes to ensure for integrity of clinical trial activities, technology and overall inspection readiness
• Consult on controls for patient safety and data integrity as part of clinical trial and/or solution design
• Review risks and oversee mitigations for completion and effectiveness
• Verify and initiate interventions to safeguard that quality excellence and GxP compliance is achieved

Manage Quality Incidents & CAPAs including Effectiveness Review

• Evaluate suspected quality incidents and confirm severity
• Support and monitor the definition completion of corrections
• Coordinate analysis and definition problem statements including engagement with key stakeholders
• Train and supervise on root cause analysis efforts & derive corrective and preventative actions
• Perform effectiveness checks and ensure for controls of periodic review
• Establish transparency for quality incidents with customers and internal stakeholders

Ensure for Security & Business Continuity Controls

• Liaise with security subject matter experts and ensure involvement in project and incident reviews
• Review and advise on business continuity and service/data resilience controls
• Verify business continuity and disaster recovery plans for being effective and exercised

Host & Leads Sponsor Audits and Inspection

• Coordinate with customer representative scope, timing and logistics
• Prepare agenda and teams to best represent services and technologies reviewed
• Represent companies’ quality management system and quality standards & Moderate and oversee session with customer representatives
• Maintain control over requests and their timely completion & Obtain feedback proactively during session and as part of closeout
• Coordinate audit response collection and review for effectiveness & Monitor completion of commitments provided as part of responses
• Confirm with customer successful closure and remediation of addressed concerns

Plan for Internal Auditing / Assessments including Suppliers

• Define an approach to internal auditing and derive audit program/plans for services and technology solutions
• Prepare audit conduct in coordination with audit sponsors agenda, logistics and scope
• Complete audit documentation including reviewed procedures, practices, evidences and interview summaries
• Provide feedback during session and as part of the closeout
• Report and communicate audit outcomes to audit sponsor and relevant stakeholders
• Create audit reports and obtain audit responses for raised observations
• Monitor action plans through to completion

Enable Continuous Improvement Framework and Arrange for Management Review

• Keep an open mind for improvement opportunities and encourage improvement initiatives
• Review quality and operational information systematically and inform quality forums
• Develop actions plan to reduce variations and defects to achieve predictable outcomes
• Promote a quality culture which applies a system approach to human fallibility

Come as you are.
We're proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

$ads={2}

 

.