LSK BIOPHARMA: Senior Manager Clinical, Quality Assurance (CQA)

LSK BioPharma issued the following announcement on May 20.

Job Title: Senior Manager Clinical, Quality Assurance (CQA)

Job Status: Full Time

Job Summary

Responsible for ensuring clinical processes within the Drug Development Group are conducted in accordance with corporate SOPs, guidelines and regulations. Develops, performs, and manages clinical quality assurance activities. Presides over clinical audits.

Job Details

Ensure that all processes contributing to the performance of a clinical trial are conducted properly

Troubleshoot clinical trials and activities

Prepare and manage the Drug Development Quality Management Plan including risk management, SOPs, training, regulatory compliance and audit readiness

Evaluate adequacy of quality assurance standards for the Drug Development Group

Monitor risk management activities

Identify training needs and organize training interventions to meet quality standards

Ensure proper maintenance of clinical trial documentation (e.g., Trial Master Files)

Create and maintain key documents for the Drug Development Group in compliance with corporate QA standards. Key documents include job descriptions, resumes, SOPs, work instructions, training matrices and training documentation

Develop and support records management procedures for the Drug Development Group

Directly interface with Drug Development departments and corporate QA to provide for vendor, site and internal GCP audits

Perform audit of clinical sites, vendors and CROs, as needed

Coordinate and support on-site audits conducted by external providers

Evaluate audit findings and implement appropriate corrective actions

Support compilation and preparation of Drug Development-related materials for submission to regulatory agencies

Evaluate quality events, incidents, queries within the Drug Development Group

Communicate any critical compliance risks noted from these activities to corporate QA and senior management

Project input and change management for quality improvements affecting CQA

Preside over improvement programs within the Drug Development Group

Keep up to date with all related drug development quality legislation and compliance issues

Utilize guidance documents, international standards, or consensus standards and interpret for guidance

Draft clinical quality assurance policies and procedures related to the Drug Development Group in accordance with corporate QA policies and standards

interpret and implement quality assurance standards from corporate QA for the Drug Development Group

Candidate Requirements

Bachelor’s degree or equivalent combination of education and experience in clinical research

Certifications an advantage including Quality Auditor, Quality Improvement Associate, Six Sigma

Quality inspection and auditing experience

Experience with implementation of corrective action programs

Drug development industry-specific experience

Strong computer skills including Microsoft Office, QA applications and databases

Knowledge of tools, concepts and methodologies of QA

Knowledge of relevant regulatory requirements

Attention to detail

Communication skills – verbal and written

Data collection, management and analysis

Problem analysis and problem solving

Planning and organizing

Reads, writes and speaks fluent English

Send resume and cover letter to

Original source can be found here.

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