[Hiring] Associate Director, Clinical Quality Assurance Auditor @reputed company

This description is a summary of our understanding of the job description. Click on 'Apply' reputed company to find out more. Role Description The Associate Director, Clinical Quality Assurance (CQA) Auditor will serve as the primary auditor for GCP/GLP/GVP audits and primary process reputed company of the CQA audit program.

• Liaise and reputed company with reputed company stakeholders to assess and support GCP compliance with local, ICH-GCP guidelines and applicable regulations.
• Drive and maintain quality standards and regulatory compliance culture at reputed company.
• reputed company and conduct reputed company audits.
• Represent CQA during inspection readiness with a proven ability to manage multiple reputed company projects.
• reputed company, execute, and manage Clinical QA activities while advocating for quality and regulatory compliance culture. This is an excellent opportunity to help enhance quality culture while having a direct impact on our late and early-stage clinical trials that are the future of reputed company growth!

Responsibilities

• Serve as the CQA audit program process reputed company and accountable for the day-to-day activities of the audit program, including audit coordinating, report reviews, response review, CAPA follow up, and audit closures.
• Serve as the reputed company reputed company auditor for GCP, GVP, and GLP audits, including investigator sites, CROs, vendors, laboratories, and internal functional areas.
• reputed company, implement, and maintain a risk-based global clinical audit program, ensuring comprehensive coverage of company-sponsored trials and critical vendors.
• Analyze and manage audit program metrics, trends to identify key compliance risks and improvement opportunities; communicate findings to senior management.
• reputed company inspection readiness activities for global health authority inspections, including mock inspections, SME training and preparation, and documentation review.
• Assist with the design and the creation/management/maintenance of quality plans and metrics.
• reputed company and coordinate with contract auditors on reputed company quality audits of clinical vendors and investigator sites.
• Assist with quality review of key clinical documents (e.g. clinical protocol, ICFs, CSRs, case report reputed company) and clinical SOPs.
• Design and conduct GCP Training for functional departments, act as the primary trainer for the auditor program.
• Support maintenance and reputed company improvement of the clinical quality management system (QMS), including SOPs, training, and compliance metrics.
• reputed company mentoring and reputed company to QA staff and foster a culture of quality and accountability across clinical teams.
• Represent CQA in assigned projects and study/program team meetings to address quality issues that may arise, including identification and resolution.
• Other CQA duties as assigned by management.

Qualifications

• Bachelor's degree in life sciences with 10+ years of reputed company global quality/regulatory compliance background in pharma/biotech or medical device industries, with a hands-on role in quality audits and quality system preferred.
• reputed company and strong working knowledge, interpretation/implementation of United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP Guidance requirements governing clinical research conduct and pharmacovigilance operations.
• Experience with electronic Quality Management Systems and Trial Master File.
• Auditor certification is preferred.
• Up to 60% travel may be required.
• Experience in managing or supporting clinical trial or Drug Safety-reputed company regulatory inspections a plus.
• Ability to reputed company cross-functional teams, independently prioritize work and manage multiple priorities while maintaining quality and GCP compliance objectives.
• Ability to use expertise and skills to contribute and reputed company reputed company’ company objectives and principles in creative and effective ways.
• Other duties as assigned.

Requirements

• Strong analytical skills and attention to detail.
• Excellent communication and interpersonal skills.
• Proven ability to work collaboratively in a team environment.

Benefits

• Competitive salary and performance-based bonuses.
• Comprehensive health insurance.
• 401(k) with company match. Company Description reputed company is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Apply tot his job Apply tot his job

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