- Conducts audits (on-site or remotely) to support qualification/approval of new and existing CROs or clinical service vendors, or to investigate specific events involving GCP and GLP compliance ('for cause' audits). Reviews and conducts follow-up on audit responses from these clinical service providers to ensure appropriate corrective and preventive actions (CAPA) are assigned and executed.
- Provides Quality Assurance input/guidance on the handling of GLP and GCP non-compliance events to ensure these events are appropriately reported, investigated, and documented and that appropriate CAPA are identified and implemented.
- Provides support for regulatory inspection readiness initiatives that may originate within Cardurion or from key CROs and clinical study sites, as requested.
- Develops and approves Quality Agreements with key CROs and clinical service providers.
- Participates as a member of internal project teams to ensure timely execution of Quality Assurance-related responsibilities to meet the established project timelines.
- Standing member of the Cardurion Quality Board for the reporting on GLP and GCP performance metrics, audit results, and recommendations to address areas of GLP and GCP compliance risk.
- Selects and manages contracted clinical Quality Assurance professionals as may be required to support execution of Clinical Quality Assurance responsibilities.
- Performs verification reviews of clinical data and related information for documents intended for regulatory submission or sharing outside of Cardurion, e.g., scientific or investor conferences.
- Supports development and implementation of Quality Policies and Standard Operating Procedures associated with the GLP, GCP, and GPvP requirements. Provides training to Cardurion colleagues and contractors on Quality System requirements, as needed.
- Conducts internal GxP compliance assessments and provides recommendations for improvements to existing quality system processes, policies, and standard operating procedures.
- Provides support for the selection, implementation, and qualification/validation of GLP and GCP-related computer systems, as needed or requested.
- Remains current in the US and international regulatory and industry requirements and inspectional trends for GLP, GCP, GPvP, and pharmaceutical quality systems.
- Highly competitive package with healthcare coverage including medical, dental and vision
- Fully funded Healthcare Savings Account for high-deductible PPO Plan
- 4 weeks paid time off annually
- 10 company paid holidays and year-end shut down
- 401k (traditional and Roth offered) with company match
- A suite of Cardurion paid insurance coverage, including life insurance, short-term and long-term disability
- Flexible spending accounts for medical and dependent care expenses
- Minimum BS degree in a Healthcare-related scientific field. Advanced degree a plus, but not required.
- Minimum of 15 years of pharmaceutical quality assurance experience in support of clinical development and clinical operations.
- Strong hands-on knowledge in the application and execution of the GLP, GCP, and GPvP requirements.
- Experience with the application of phase-appropriate quality systems across the product development lifecycle.
- Strong working knowledge in the application of the US and EU GCP guidelines; the related ICH and FDA guidance documents; and the industry standard requirements for Pharmaceutical Quality Systems.
- Experience in hosting and supporting regulatory inspections and interfacing with regulatory authorities.
- Strong oral and written communication skills.
- Ability to effectively communicate with third-party clinical service providers (e.g., CROs and clinical service vendors) and their Quality Assurance staff members to resolve issues and ensure Cardurion requirements are met.
- Ability to prepare audit plans and reports, quality agreements, and standard operating procedures in accordance with the Cardurion Quality System requirements.
- Oral and presentation skills to address colleagues at all levels of the organization, e.g., development and delivery of training presentations, coordination of inspection readiness activities, and development and presentation of management reports on Quality System performance.
- Ability to work on multiple projects, manage competing priorities, and collaborate cross-functionally in a dynamic fast-paced environment.
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Director, Clinical Quality Assurance - Burlington, United States - Cardurion Pharmaceuticals, Inc
3 weeks ago
Description
Job Description
Job DescriptionDescription:Why join Cardurion Pharma?
At Cardurion, we are advancing the understanding of signaling pathways that regulate heart cell function. Our programs seek to modulate these pathways to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our website to learn more about our Company and how we are advancing our drug candidates to improve health outcomes and impact lives around the world.
The Role:
The Director, Clinical Quality Assurance is responsible for developing, maintaining, and executing the requirements of the Cardurion Quality Systems as they pertain to clinical development of drug products for the company. The position provides Quality Assurance support for the Translational Medicine, Clinical Development, and Clinical Operations functions, including the areas of clinical pharmacology, toxicology, pharmacovigilance, clinical trial conduct, and clinical data management. The position also contributes to the development, performance monitoring, and continuous improvement initiatives related to the company's Quality Systems and their associated processes, policies, and standard operating procedures.
Under the direction of the Vice President, Head of Quality, the position provides quality assurance oversight and support for the various contract research organizations (CROs), clinical study sites, and clinical service vendors that perform GLP and GCP-related activities for the company.
The Director, Clinical Quality Assurance works directly with the Cardurion Quality Team, Translational Medicine, Cardurion K.K., Clinical Development, Clinical Operations, Regulatory Affairs, and the corresponding quality assurance staff members from the various CROs, clinical study sites, and clinical service providers to ensure effective execution of the Cardurion Quality System requirements and compliance with the applicable GLP, GCP, and GPvP guidelines, regulations, and industry standards.
Here's What You'll Do:
Quality Assurance oversight of activities performed at CROs and clinical service vendors involved in the conduct of human clinical trials for Cardurion drug candidates, including:
Here's What We'll Bring to the Table:
Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Requirements:
Here's What You'll Bring to the Table:
