Associate Director Clinical QA - Remote
Tolmar
Date: 3 days ago
City: Fort Collins, CO
Contract type: Full time
Remote
Purpose and Scope
This position will ensure compliance in relation to GCP principles with respect to domestic and international regulations and guidance (e.g. FDA, EMA, Health Canada and ICH).
Essential Duties & Responsibilities
Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.
This position will ensure compliance in relation to GCP principles with respect to domestic and international regulations and guidance (e.g. FDA, EMA, Health Canada and ICH).
Essential Duties & Responsibilities
- Provides Quality oversight and support of Tolmar Inc. clinical development programs.
- Supports the Tolmar Inc. Clinical Quality Management System through the development, implementation and management of Quality Assurance procedures, processes and systems in accordance with ICH E6 (Rx).
- Executes on and/or provides oversight of quality monitoring and assurance of clinical trial execution of Tolmar Inc. sponsored protocols.
- Executes on and/or provides oversight of clinical investigator audits, documentation audits and other study-specific or process audits.
- Engages with study teams and functions for proactive inspection readiness across all clinical programs.
- Conducts external and internal audits to assess compliance with GCP requirements, investigational plans and company standards for clinical trial-related activities.
- Communicates audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop Corrective and Preventive Action Plans (CAPAs), addressing root causes.
- Tracks, reviews, approves, and assesses the efficiency of CAPAs.
- Ensures integrity of data for clinical studies in support of regulatory submissions.
- Develops relevant training materials and conducts GCP training.
- Assists with the preparation, coordination, and management of regulatory agency inspections.
- Monitors regulatory and industry trends/actions and reports regularly to Quality Assurance management.
- Interfaces with Tolmar Clinical Development and Regulatory colleagues; collaborates with additional internal departments and external Contract Research Organizations.
- Other duties as required.
- The Associate Director Clinical QA is expected to operate within the framework of Tolmar’s Core Values:
- Consistently operate with the highest standards of ethics and compliance.
- Take ownership of your actions, success and setbacks.
- Respect each other and understand that honest collaboration is at the heart of our company success.
- Go the extra mile to make things happen.
- Be committed to all we do and the patients we serve.
- Embrace change with enthusiasm.
- Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.
- In-depth knowledge and clear understanding of GCP regulations and industry standards.
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team, both internally and externally. Ability to establish and maintain effective working relationships.
- Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment.
- Working knowledge of GCP principles with respect to domestic and international regulations and guidance (e.g. FDA, EMA, Health Canada and ICH).
- Understanding of quality systems and how quality systems are designed and operate to satisfy regulatory requirements.
- Experience in drafting, reviewing and approving GCP related documents (SOPs, protocols, reports, etc.).
- Experience working with Contract Research Organizations including understanding and review of TOROs, contracts and other associated business related documents.
- Knowledge of drug development processes.
- Familiarity with electronic Quality Management and Clinical trial management systems.
- Ability to quickly learn, access and work within computer platforms internally and externally
- Ability to independently analyze and resolve moderate to complex issues.
- Demonstrated proficiency in application of QA principles, concepts, industry practices and standards.
- Problem solving skills, effective written and verbal communication skills.
- Excellent documentation skills and attention to detail. Orientation for meticulous work.
- Requires an ability and willingness for approximately 25% travel - domestic & international, consistent with the project needs.
- Bachelor’s Degree in Biological Sciences, Chemistry or relevant discipline required; Master’s Degree preferred.
- Seven or more years of experience in the pharmaceutical/biotech industry with increasing responsibility and relevant QA experience in a pharmaceutical or biotechnology environment, or an equivalent combination of education and experience.
- Two or more years of experience in a Clinical Quality Assurance position with extensive experience in GCP regulations required.
- Conditions are normal for an office environment. Potential for remote work will be considered.
- Annual pay range: $160,000 - $170,000
- Bonus eligible
- Benefits information: https://www.tolmar.com/careers/employee-benefits
Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.
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