Quality Manager

Job Description

About CalyxHere at Calyx, our mission is to shape the future of clinical research. Backed by decades of diverse global experience and the brightest minds in the industry, with our industry leading technology solutions, we support the Clinical Research industry bring new,advanced medical treatments to market, faster. At Calyx, we are one team. We learn, grow, and win together. Wherever you are in the world, by working for Calyx you will be supported by a team whose values and goals match your own and who are passionate about helping others. Are you ready. To help us. Change the WorldJob Purpose: 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

Provide Regulatory Expertise & Training

• Schedule and deliver regulatory training sessions
• Monitor for training compliance
• 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

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

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

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

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, evidence, and interview summaries

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

Skills:

• Experience in quality and compliance as it pertains to technology enabled services (preferable in pharmaceutical / clinical research industry)
• Knowledge of elements of a quality management system and continuous improvement methodologies.
• Excellent interpersonal, verbal, and written communication skills
• Highly motivated and seeks opportunities for development
• Exhibits a sense of urgency when addressing problems and ensures completion of commitment
• Culturally aware and ability to think and work globally
• Effectively communicate issues, along with potential recommendations, to various functional groups.

Knowledge and Experience:

• Clinical trials and/or research work experience preferred, with emphasis on GCP and technology compliance.
• Experience in advising project teams from a quality and compliance perspective
• Experience in quality management system maintenance, risk management, auditing and/or computerized system

Education:

• Educated to degree level or equivalent practical experience

Keyskills :
AuditComplianceQuality AssuranceTrainingPharmaceutical Industry