Director, Quality
Parexel International Corporation
Hyderabad, Telangana, India
1d ago
  • 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.
  • 2021-02-11 01 : 01 : 17

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