Senior Manager, Quality Assurance
US-AnywhereRemote
1 month ago
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Job Description
Overview
As a Manager of Quality Assurance you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What you will be doing:
Qualifications
You are:
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
As a Manager of Quality Assurance you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What you will be doing:
- Perform and lead audits including but not limited to: clinical investigator sites, internal GCP systems/processes, external vendors, and clinical trial documents.
- Identify and report systematic issues and areas for improvement with the assistance of management/senior auditor, as needed.
- Independently perform audits, including audit preparation, conduct, presentation and timely reporting of audit findings and evaluation of CAPA Plans.
- Ensure appropriate corrective and preventative actions have been committed to by auditees.
- Conduct post-audit meetings to present/discuss audit findings.
- Assist in assessment of appropriate CAPA implementation.
- Perform other tasks as assigned by line manager.
- Contribute in the continuing development of a quality culture
- Approximately 50% travel
Qualifications
You are:
- BS/BA, or MS and a minimum of 10 or 5 years experience, respectively, in Biotech, Pharma, Medical Device, or Clinical Research Organization.
- Working knowledge of Good Clinical Laboratory Practice (GCLP) required
- Working knowledge of relevant Good Clinical Practices (GCP) and applicable regulations/guidelines. (e.g. ICH E6, 21 CFR Parts 50, 54, 56, and 312).
- Experience working with CROs, vendors, and relationship management preferred.
- Prior experience managing individuals preferred.
- Vaccine clinical trials experience is a plus.
- Excellent auditing skills and ability to communicate significant observations to Auditees in a sound and factual manner.
- Ability to manage multiple projects in a fast-paced environment.
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Ability to work independently and within a team environment.
- Strong communication and presentation skills, verbal and written.
- Ability to influence and negotiate effective solutions.
- Strong interpersonal skills and ability to provide training and mentoring to auditor trainees and junior staff.
- GCLP experience
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
About Pharmaceutical Research Associates, Inc
Learn More About Pharmaceutical Research Associates, IncPharmaceutical Research Associates, Inc Careers
Joining Pharmaceutical Research Associates, Inc presents an unparalleled opportunity to become part of a leading team in the pharmaceutical research industry. This company stands as a beacon of innovation, leadership, and professional growth.
Explore Job Opportunities
Pharmaceutical Research Associates, Inc is actively seeking skilled professionals eager to impact the world of pharmaceuticals and healthcare. With a variety of job opportunities available, candidates can find positions that match their skills and career ambitions perfectly.
Experience the Culture and Benefits
At Pharmaceutical Research Associates, Inc, the culture thrives on diversity, innovation, and a commitment to employee growth. The company offers comprehensive benefits designed to support the health, well-being, and financial security of each team member. From diversity training to leadership programs, employees are equipped with resources to thrive both professionally and personally.
Internship Programs
For those starting their career journey, Pharmaceutical Research Associates, Inc provides robust internship programs. These opportunities allow interns to work alongside experienced professionals, gaining invaluable industry insight and enhancing their resume through practical, hands-on experience.
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Career advancement is a cornerstone of employment at Pharmaceutical Research Associates, Inc. The company supports career growth through professional development programs, networking opportunities, and leadership training, ensuring that every team member has the tools to succeed.
Innovative Work Environment
Pharmaceutical Research Associates, Inc is at the forefront of pharmaceutical innovation. The team is dedicated to pioneering research that leads to new discoveries and solutions in healthcare, offering employees a chance to contribute to meaningful projects that push industry boundaries.
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Pharmaceutical Research Associates, Inc is hiring! Search open positions that align with your professional skills and interests. The company values curious, creative, and solution-driven team players ready to drive success in the pharmaceutical industry.
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