Vice President Quality Assurance
Vice President Quality Assurance
Posted on :
20-01-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
20-01-2025
Job Description
Job Title: Vice President Quality Assurance
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Executive
What We Do
Care Access is a unique multispecialty network of research sites which operates as one connected team of physician investigators nurse coordinators and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every participant. By removing this bottleneck Care Access is helping accelerate the approval and delivery of critical and lifesaving therapies.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another find new ideas to accelerate medicine and seed a longterm impact for generations.
Position Overview
The Vice President Quality Assurance will be responsible for developing implementing and overseeing the quality assurance strategies and processes across Care Access. This senior executive role requires a visionary leader with a deep understanding of quality assurance principles a track record of successful implementation and the ability to inspire and lead a team of quality professionals.
What You'll Be Working On
Duties Include But Not Limited To
Knowledge Skills And Abilities
We serve study participants and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.
At Care Access every day we are advancing medical breakthroughs. We’re uniting standard study participant care with cuttingedge treatments and research. Our work brings lifechanging therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the
physicians and caring for the participants in our clinical research studies.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity or expression pregnancy age national origin disability status genetic information protected veteran status or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices terms and conditions of employment and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate under any circumstances the use of any form of forced or involuntary labor child labor or human trafficking. This extends to suppliers partners or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
Care Access is a unique multispecialty network of research sites which operates as one connected team of physician investigators nurse coordinators and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every participant. By removing this bottleneck Care Access is helping accelerate the approval and delivery of critical and lifesaving therapies.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another find new ideas to accelerate medicine and seed a longterm impact for generations.
Position Overview
The Vice President Quality Assurance will be responsible for developing implementing and overseeing the quality assurance strategies and processes across Care Access. This senior executive role requires a visionary leader with a deep understanding of quality assurance principles a track record of successful implementation and the ability to inspire and lead a team of quality professionals.
What You'll Be Working On
Duties Include But Not Limited To
- Develop and implement a comprehensive quality assurance strategy for clinical research in alignment with GCP and regulatory requirements.
- Lead and manage the Quality Assurance department ensuring alignment with overall business strategy and compliance with industry standards setting clear objectives and fostering a culture of quality compliance and continuous improvement.
- Collaborate with other senior leaders to integrate quality assurance seamlessly into all operations.
- Support other functions in activities as appropriate.
- Oversee the development and implementation of quality assurance policies procedures and standards.
- Maintain robust quality management systems (QMS) to ensure compliance with GCP ICH guidelines and applicable regulatory requirements.
- Plan conduct and oversee internal audits of sites systems and processes.
- Lead the preparation for and management of external regulatory audits and inspections.
- In partnership with other operations develop and implement risk management strategies to identify assess and mitigate qualityrelated risks across the organization.
- Guide the organization in proactive quality risk management and facilitate the resolution of quality issues.
- Establish key performance indicators (KPIs) to measure effectiveness of quality assurance activities and initiatives.
- Provide regular reports to executive leadership on trends and improvement areas.
- Serve as primary point of contact for quality assurance matters with sponsors CROs and regulatory bodies.
- Stay current with industry trends regulatory changes and advancements in clinical research.
- This is a remote position with up to 50% travel requirements. Length of travel will depend upon study requirements staff needs and company initiatives.
Knowledge Skills And Abilities
- Expert knowledge of ICH GCP and understanding of international regulatory requirements.
- Strong organizational skills ability to multitask attention to detail selfstarter and ability to prioritize.
- Strong communication negotiation and presentation skills.
- Proven ability to manage and develop people.
- Degree in biomedical sciences or related scientific discipline or a combination of education and experience in health sciences industry.
- 15 years in clinical research within the pharmaceutical industry CRO site network or regulatory authority with at least 10 years in clinical quality assurance/quality management or related area of responsibility.
- Experienced with auditing clinical vendors and investigator sites.
- Experienced in hosting / managing regulatory inspections.
- PTO/vacation days sick days holidays.
- 100% paid medical dental and vision Insurance. 75% for dependents.
- HSA plan
- Shortterm disability longterm disability and life Insurance.
- Culture of growth and equality
- 401k retirement plan
We serve study participants and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.
At Care Access every day we are advancing medical breakthroughs. We’re uniting standard study participant care with cuttingedge treatments and research. Our work brings lifechanging therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the
physicians and caring for the participants in our clinical research studies.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity or expression pregnancy age national origin disability status genetic information protected veteran status or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices terms and conditions of employment and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate under any circumstances the use of any form of forced or involuntary labor child labor or human trafficking. This extends to suppliers partners or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
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Employment Type
Full Time
Key Skills
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