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Salary Overview:
As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.
Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.
Job Summary:
Responsibilities:
Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.
As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.
Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.
Job Summary:
The Quality Assurance Director specializes in developing, planning and executing audits to ensure compliance with regulatory standards and company policies & procedures. Provides direction in support of customer accounts with quality and compliance, and associated audit program where applicable. Provide insights, analyses and support in the promotion and assessment of compliance with regulations, guidelines, and operating procedures.
Responsibilities:
Duties/Responsibilities:
- Establish and maintain strong working relationships with internal and/or external customer team leads and counterparts, as assigned
- Provide actionable insights to customer counterparts, QA Leadership and Senior Management
- Drive quality improvements and efficiencies along with risk mitigation based on QA data analyses, operational performance data, knowledge of process management, changing regulations and customer expectations Provide consultation and support concerning compliance with regulations and appropriate controls, quality measures and risk assessment and mitigation in the development of improved or new service offerings across the business
- Lead and project manage internal quality improvement initiatives as assigned
- Assist in enhancement and establishment of Quality Assurance and control policy and risk identification and mitigation by providing consultation and recommendations to regional and Enterprise QA Leadership
- Serve as author for QA Standard Operating Procedures (SOPs) as assigned
- Serve as QA representative on Standard Operating Procedures (SOP) for functional areas as assigned
- Participate in or lead teams for special projects as assigned. Teams may be cross functional.
- Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
- Conduct trend analysis of audit results and provide QA management with initial root cause analysis
- May present trend analysis results and QA metrics and insights to Senior management
- May contribute to proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections
- Recommend process and systems for audit, may contribute to the development of the related audit plans and oversee the delivery of these audits, review the Corrective and preventive actions (CAPAs) and ensure appropriate follow up
- Plan, schedule, conduct, report and close internal/contracted GCP audit activities where applicable
- May train/coach junior auditors to perform GCP audits
- Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, appraising performance, and guiding professional development, rewarding and disciplining employees, addressing employee relations issues and resolving problems. Approve actions on human resources matters.
- Oversee documentation, reporting, and closure of significant compliance issues, audit/inspection findings.
- Support QA Management Leadership in proposal reviews and reporting QA metrics and insights as assigned.
- Act as primary back-up for QA Leadership as assigned.
- Other duties as assigned.
Required Skills/Abilities:
- Expertise in project management demonstrated ability to successfully manage people/projects. Proactive problem-solving abilities and follow-through.
- Knowledge of field organizational strategies - The ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-making.
- Extensive knowledge of clinical research - Understands the drug development process.
- Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Ability to review protocols, programs, and assess the success of a project.
- Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Sponsor, team members and internal relationships. Ability to conduct effective presentations.
- Computer skills - Working knowledge of MS Office suite, Clinical Conductor CTMS and relevant CRM system. Able to generate business correspondence, create forms and generate reports as required.
- Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done
- Ability to communicate effectively in English (both verbal and written).
- Knowledge of word-processing, spreadsheet, and database applications.
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
- Considerable knowledge of Quality Assurance processes and procedures.
- Strong interpersonal skills.
- Excellent problem solving, risk analysis and negotiation skills.
- Effective organization, communication, and team orientation skills.
- Senior Management experience in Quality Assurance.
- Ability to influence and guide others at all levels of management.
- Demonstrated ability to lead and manage multiple responsibilities.
- Ability to manage costs effectively through appropriate resource allocation.
- Ability to articulate and define departmental needs and processes.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Up to 30% travel, as needed
Education and Experience:
- Bachelor’s degree in life sciences or related field preferred
- 8+ years Quality Assurance experience in pharmaceutical, CRO, biotech or related area
- Minimum of 5 years of Line Management Experience preferred; Or equivalent combination of education, training and experience.
- GCP Auditing skills (Planning, preparation, conduct, reporting and follow up)
- Ability to train and coach junior GCP auditors
Physical Requirements:
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.
NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
