- Clinical Trial Management : Oversee the planning, execution, and monitoring of clinical trials to ensure compliance with protocols, regulatory requirements, and industry standards.
- Quality Assurance : Develop and implement quality assurance programs and processes to ensure the highest standards of clinical quality throughout the product lifecycle.
- Regulatory Compliance : Ensure compliance with all relevant regulatory requirements, including FDA and EU regulations, ISO standards, and Good Clinical Practice (GCP) guidelines.
- Risk Management : Identify potential risks to clinical quality and develop strategies to mitigate risks effectively. Conduct risk assessments and implement controls to ensure the safety and integrity of clinical trials.
- Vendor Management:
- Data Management : Oversee data collection, analysis, and reporting for clinical trials. Ensure the accuracy, integrity, and confidentiality of clinical trial data.
- Audit Support : Facilitate and oversee the responses to audit and inspection observations. Maintain regulatory inspection knowledge as it relates to GCP inspections by regulatory agencies worldwide. Develop, update and maintain GCP inspection procedures and guidelines.
- CAPA Management Support : Ensure all actions related to audits and inspections are implemented in a timely manner. Track all inspection CAPA
- Training and Education : Provide training and support to clinical operations staff and other stakeholders to promote awareness and understanding of clinical quality requirements and best practices.
- Continuous Improvement : Drive continuous improvement initiatives to enhance the efficiency and effectiveness of clinical quality operations. Identify opportunities for process optimization and innovation. Recognize and respond to new and emerging risks through the use of technology.
- Cross-Functional Collaboration : Collaborate with cross-functional teams, including research and development, regulatory affairs, and quality assurance, to ensure alignment and integration of clinical quality activities with overall business objectives.
- Bachelor's degree in a relevant scientific or healthcare field. Advanced degree (e.g., Master's or PhD) preferred.
- 10+ years of experience in clinical quality operations, with a focus on medical device or pharmaceutical industry.
- In-depth knowledge of clinical trial management, regulatory requirements, and quality assurance principles.
- Experience in designing and generating clinical documentation required per EU Medical Device Regulation, including authoring Clinical Evaluation Plans and Reports, Post Market Clinical Follow-up and driving clinical input to Post Market Surveillance Plans and Reports
- Strong cross-functional collaboration skills.
- Experience with delivering effective CAPA management solutions
- Experience with risk management tools and processes within the clinical quality framework.
- Excellent project management and organizational skills.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
- Proven track record of success in leading clinical quality operations for complex medical device projects.
- Certification in clinical research (e.g., CCRA, CCRC) or quality management (e.g., CQM/OE) is a plus.
- Ensures environmental consciousness and safe practices are exhibited in decisions
- Use of computer and telephone equipment and other related office accessories/devices to complete assignments
- May work extended hours during peak business cycles
- Physical requirements such as lifting specific weights
- Some travelling is expected
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Director, Clinical Quality Operations - Manchester, United States - Sequel Med Tech, LLC.
Description
About SequelSequel Med Tech is an early-stage company developing the next generation of precision drug delivery devices.
Job Overview
As the Director of Clinical Quality Operations at Sequel Med Tech, you will play a pivotal role in ensuring the highest standards of quality in our clinical trials.
Reporting directly to the Vice President of Quality, you will be responsible for the development and oversight of our quality program specifically tailored for clinical trials.
Your expertise will be instrumental in maintaining regulatory compliance, optimizing operational efficiency, and fostering a culture of quality excellence within our organization.
Job Responsibilities and Essential Duties
Manage relationships with external vendors, including contract research organizations (CROs) and clinical trial sites, to ensure quality and compliance with contractual agreements.
Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
