Executive Director of Quality Assurance
Description
Company Overview:
The Clinical Research Division at The IMA Group is a dynamic hub of expertise and innovation, dedicated to advancing healthcare through clinical trials and studies. Our team of seasoned professionals collaborates with industry leaders, conducting patient-centric research across diverse therapeutic areas. Committed to ethical practices and regulatory compliance, we aim to pioneer groundbreaking medical solutions that shape the future of healthcare.
Job Summary:
IMA Clinical Research is searching for an Executive Director of Quality Assurance who will lead the development and implementation of cross-functional strategies, adhering to quality and systems management standards. This role entails overseeing all Quality Assurance activities to ensure compliance with relevant regulations and guidelines for client-sponsored clinical trials, while also managing training initiatives for IMA Clinical Research.
This position can be based in any IMA office location or be a remote work-from-home role, anywhere in the US. It requires a willingness to travel up to 25% within North America for client meetings, audits, or site support as needed.
This position is not considering candidates from New York City, Chicago, California, Colorado, or Washington states at this time.
Responsibilities:
- Drive a ‘Culture of Quality’ by conceiving, collaborating, and supporting implementation of specific actions, processes, and behaviors.
- Provide strategic and technical leadership of Quality Assurance activities for IMA Clinical Research.
- Identify, implement, monitor, and promote best practices for Quality Assurance and Clinical Systems.
- Identify and resolve, or escalate, all product, process, or customer Quality-related issues.
- Develop and implement risk mitigation measures, processes, and infrastructure supporting clinical research quality program needs.
- Manage and maintain departmental and company standard operating procedures (SOPs), including oversight of the Clinical Research Division SOP development and approval process.
- Create and manage GCP audit program, including routine and non-routine audits of clinical investigator sites, and lead inspections by Sponsors, CROs, FDA, and other regulatory agencies.
- Develop and maintain a quality system to track issues and related CAPAs to closure, as well as develop and evaluate quality metrics to drive business quality and ensure compliance. Additionally, oversee the Training leadership and training program for clinical research site personnel, and execute additional tasks or initiatives as assigned.
Qualifications:
- BS/BA in business, life sciences, or equivalent and relevant qualification.
- Ten (10+) years in clinical research, site network, CRO, pharmaceuticals, or related operational/quality assurance.
Knowledge and Skills:
- Strong understanding of GCP and clinical trial regulatory requirements.
- Strong understanding of clinical research and site operations.
- Strong interpersonal and communication skills.
- Highly organized and detail-oriented.
- Proficient in Microsoft Office Suite.
Benefits:
- Complete Health Coverage: Comprehensive Health, Dental, and Vision Insurance packages to ensure your well-being.
- Balanced Lifestyle: Generous paid time off, holidays, and a floating holiday to maintain a healthy work-life balance.
- Retirement: A 401k plan with employer matching for a secure financial future.
- Comprehensive Benefit Offerings: Benefits include LTD, STD, Flexible Spending Account, Voluntary Life, Voluntary ADD, and Company-paid Life Insurance and ADD coverage.
- Inclusivity and Engagement: Actively participate in our DEI Committee Initiative, shaping an inclusive workplace culture.
- Tuition Assistance and Student Loan Repayment Assistance: Benefit from IMA’s tax free tuition reimbursement and tax-free student loan repayment assistance program to fuel your ongoing educational journey and to help you pay for the degree you already have!
- Family Support: Paid maternity leave and paid parental leave reflecting our commitment to supporting family needs.
- No on Call Responsibilities: When you are home, you can leave work behind.
The IMA Group is an Affirmative Action/Equal Opportunity Employer
Our Government Services Division supports local, state, and federal agencies and delivers professional and objective medical and psychological examinations as well as ancillary services. Our Payer Services Division meets the evaluation and screening needs of Carriers, TPAs, Public Entities and Employers and includes behavioral health and physical medicine specialty services, working with a wide range of organizations within the workers' compensation, disability, liability, and auto markets. Our Clinical Research Division performs all types of Phase II-IV clinical trials in multiple therapeutic areas through a flexible nationwide network of site locations and virtual capabilities.