Director, Quality

• 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

• Stay abreast of regulatory updates and customer interpretation

• Create white/position papers on regulatory expectations

• Develop training material for operational, technical and quality staff on regulatory

• 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

• 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

• 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

• Evaluate suspected quality incidents and confirm severity

• Support and monitor the definition completion of corrections

• Lead evaluations for serious breach criteria, security incident categorization and unauthorized disclosure

• 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

Qualifications• Expert in quality and compliance as it pertains to technology enabled services (preferable in pharmaceutical / clinical research industry)

• Advanced 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.

• Intermediate desktop software skills (MS Office, Excel, Adobe PDF etc.).

• Effectively communicate issues, along with potential recommendations, to various functional groups.

• Work professionally with highly confidential information.

• High ability to train new and existing less experienced Quality members.

• Work independently and consistently in a fast-paced environment.

• Clinical trials and/or research work experience preferred, with emphasis on GCP and technology compliance.

• Familiar in services and solutions as it relates to clinical trial activities i.e. clinical trial management, medical imaging, randomization and trial supply management, clinical data management and/or regulatory information management

• Expert in advising project teams from a quality and GxP compliance perspective

• Expert in quality management system maintenance, risk management, auditing and/or computerized system

• Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification

• Postgraduate degree in a science, technology or industry-related discipline preferred.