Description

We’re on a mission to change the future of clinical research. At Perceptive, we help the 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:HEALTH: - Medical plan for you and your dependents. - Personal Accident Insurance- Life Insurance- Critical illness coverWEALTH: - Salary structure and Flexi basket- Provident fund of 12%- Gratuity scheme YOURSELF: Internal growth and development programs & trainingsThe Quality Manager is responsible for reviewing and consulting on Standard Operating Procedures and associated documents. The role will process Quality Incidents, perform root cause analysis and lead sponsor and internal audits. The Quality Manager will also define, adopt and oversee quality and compliance for processes and standards that are fundamental to technology-enabled services. The role provides expertise for solution development and computerized system validation. In collaboration with business partners, the role also monitors, identifies and implements continuous process improvement across all business units.Key Accountabilities: Review SOPs for Quality Excellence & Compliance<ul><li>Train & advise internal stakeholders in creating & updating Standard Operating Procedures </li><li>Review Standard Operating Procedure for adherence to regulatory and critical to quality criteria. </li><li>Maintain and safeguard the integrity of the quality management system as a whole. </li><li>Release Standard Operating Procedures and associated documents. </li><li>Maintain an inventory of Standard Operating Procedures including its history. </li></ul>Provide Regulatory Expertise & Training <ul><li>Schedule and deliver regulatory training sessions. </li><li>Monitor for training compliance, up-to-date Curriculum Vitae and Job Descriptions </li><li>Ensure that the organization has relevant regulatory expertise proven by personal and quality records.</li></ul>Review & Assess Suppliers<ul><li>Establish standards and ‘critical to quality’ criteria for supplier evaluations.</li><li>Prepare assessment/audits plans for suppliers’ products/services</li><li>Coordinate with supplier representatives and internal stakeholders on the scope, timing and logistics of the review/audit</li><li>Conduct supplier audit/assessments following a risk-based approach</li><li>Report on the review/audit outcomes to management, internal stakeholders and suppliers.</li><li>In conjunction with internal stakeholders, oversee remediation plans provided by the supplier.</li></ul>Oversee and Consult on Quality of Service & Technology Deliverables <ul><li> Engage in clinical trial and technology projects to oversee deliverables for meeting ‘critical to quality’ criteria</li><li>Provide training, guidance, consultation and overall quality expertise in support of clinical trial and technology validation activities</li><li>Oversee and support changes to ensure for integrity of clinical trial activities, technology, and overall inspection readiness</li><li>Consult on controls for participant safety and data integrity as part of clinical trial and/or solution design</li><li>Review risks and oversee mitigations for completion and effectiveness</li><li>Verify and initiate interventions to safeguard that quality excellence and GxP compliance is achieved</li></ul>Manage Quality Incidents & CAPAs including Effectiveness Review <ul><li>Evaluate suspected Quality Incidents and confirm the severity.</li><li>Support and monitor the completion of corrections.</li><li>Coordinate the analysis and definition of the problem statement, including engagement with key stakeholders.</li><li>Provide training on root cause analysis techniques and the derivation of Corrective and Preventive actions.</li><li>Perform Effectiveness Checks.</li><li>Establish transparency for Quality Incidents with customers and internal stakeholders.</li></ul>Ensure for Security & Business Continuity Controls <ul><li>Liaise with security subject matter experts and ensure involvement in project and incident reviews. </li><li>Review and advise on business continuity and service/data resilience controls. </li><li>Verify business continuity and disaster recovery plans for being effective and exercised. </li></ul>Manage Business/Technology Risks<ul><li> Evaluate identified Business/Technology Risks and confirm severity and likelihood.</li><li>Oversee the documentation of identified Business/Technology Risks, including severity, likelihood, prioritization, mitigating actions and acceptance of risk mitigation decision. </li><li>Monitor identified Business/Technology Risks and track to completion. </li><li>Provide training on Business/Technology Risk management.</li></ul>Lead Sponsor Audits, assist in Inspection management<ul><li>Coordinate with customer representatives for the scope, timing, and logistics of the audit.</li><li>Formulate an agenda to best represent the services and technologies that will be reviewed.</li><li>Represent the Company’s Quality Management System and quality standards during audit sessions with customer representatives</li><li>Maintain control over requests and their timely completion</li><li>Obtain feedback proactively during audit sessions and as part of the audit closeout</li><li>Coordinate audit response collection and review for effectiveness</li><li>Monitor completion of commitments provided as part of responses.</li><li>Confirm with the customer that closure and remediation of audit concerns have been successful.</li></ul>Plan for Internal Auditing / Assessments including Suppliers <ul><li>Define an approach to internal auditing and derive audit programs/plans for services and technology solutions. </li><li>Agree scope, logistics and agenda of the audit in conjunction with the audit sponsor.</li><li>Complete audit documentation and retain associated evidence</li><li>Provide feedback during audit sessions and as part of the audit closeout report audit outcomes to the audit sponsor and other stakeholders</li><li>Create audit reports and obtain audit responses for observations raised.</li><li>Monitor action plans to completion.</li></ul>Enable Continuous Improvement Framework and Arrange for Management Review <ul><li>Keep an open mind for improvement opportunities and encourage improvement initiatives. </li><li>Review quality and operational information systematically and inform quality forums. </li><li>Develop an action plan to reduce variations and defects to achieve predictable outcomes. </li><li>Promote a quality culture which applies a system approach to human fallibility. </li></ul><div><div>Skills: </div><div><ul><li>Experience in quality and compliance as it pertains to technology-enabled services (preferably in the pharmaceutical/clinical research industry)</li><li>Knowledge of elements of a Quality Management System and continuous improvement methodologies</li><li>Excellent interpersonal, verbal and written communication skills</li><li>Highly motivated and seeks opportunities for development</li><li>Exhibits a sense of urgency when addressing problems and ensures completion of commitments</li><li>Culturally aware and has the ability to think and work globally</li><li>Intermediate desktop software skills (MS Office, Excel, Adobe PDF etc.)</li><li>Effectively communicates issues, along with potential recommendations, to various functional groups.</li><li>Works professionally with highly confidential information.</li><li>Works independently and consistently in a fast-paced environment.</li></ul></div><div>Knowledge and Experience: </div><div><ul><li>Clinical trials and/or research work experience preferred, with emphasis on GCP and technology compliance.</li><li>Familiar with the services and solutions that relate to clinical trial activities, for example, clinical trial management, medical imaging, randomization and trial supply management, clinical data management and/or regulatory information management.</li><li>Experience in working in a quality and GxP compliance environment</li><li>Experience in Quality Management System maintenance, risk management, auditing and/or computerized systems.</li></ul></div></div><div><div></div><div>Education: </div><div><ul><li>Educated to degree level (technology, biological science, pharmacy or other health-related discipline preferred) or equivalent qualification. </li></ul></div></div>Come as you are.We're proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, 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.

Quality Manager

Description

Perceptive

Pipeline