Senior Specialist, Clinical Quality Assurance Expert
2 months ago
Job Summary
We are seeking a highly skilled Senior Specialist, Clinical Quality Assurance to join our QIAGEN Manchester Quality Assurance team. As a key member of our team, you will be responsible for ensuring the quality and compliance of clinical trials, including the testing and registration of diagnostic tests.
Key Responsibilities
- Work with the Clinical Affairs team to ensure compliance during trial activities, including closure of deviations and complaints.
- Represent Clinical QA as a member of project teams for planned and ongoing clinical trials, including quality review of clinical relevant documentation.
- Support qualification and perform independent QA audits of clinical study sites.
- Participate in the QIAGEN internal audit program.
- Review Clinical Affairs SOPs.
Requirements
- Degree qualification in a relevant subject, or equivalent employment experience.
- Proven working experience and knowledge of clinical regulations, standards, guidelines, and best practice, including CFR 812, BIMO, ISO standards, and ICH GCP.
- Demonstrable working knowledge of global In Vitro Diagnostic Regulations (EU IVDR, US 21CFR820).
- Qualified Auditor and experience in performing as a Subject Matter Expert in regulatory inspections and other formal audits.
- Willingness and availability to travel internationally (Europe + USA) up to 10%.
- Ability to work independently while exercising good judgment and decision-making within defined practices and policies.
- Excellent communication and interpersonal skills with the ability to work effectively with multinational/cultural teams and individuals.
What We Offer
- Possibility to develop in an international company.
- Attractive pension.
- Private Healthcare.
- Private Dentalcare.
- Gym membership contribution.
- Access to an Employee Assistance Programme.
- A range of retail discounts and offers.
- Opportunity to join internal QIAGEN communities.
- Enhanced maternity package.
- Flexible working options.
- Bonus/commission.
- 25 days annual leave (potential to increase linked to service).
QIAGEN is an Equal Opportunity Employer
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Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our diagnostic tests, and we're seeking a talented Senior Specialist to join our Clinical Quality Assurance team.Position DescriptionWe're looking for a...
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Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our diagnostic tests, and we're seeking a talented Senior Specialist to join our Clinical Quality Assurance team.Position DescriptionWe're looking for a...
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Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a vision to make improvements in life possible. Our mission is to make a real difference in science and healthcare, and we're constantly looking for new talent to join us.Position DescriptionWe're seeking a Senior Specialist, Clinical Quality Assurance to join our Manchester Quality Assurance team. The successful candidate...
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Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a vision to make improvements in life possible. Our mission is to make a real difference in science and healthcare, and we're constantly looking for talented individuals to join our team.Position DescriptionWe're seeking a Senior Specialist, Clinical Quality Assurance to oversee quality and compliance for the Clinical...
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Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a vision to make improvements in life possible. Our mission is to make a real difference in science and healthcare, and we're looking for talented individuals to join our team.Position DescriptionWe're seeking a Senior Specialist, Clinical Quality Assurance to join our Manchester Quality Assurance team. As a key member of...
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Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our diagnostic tests, and we're seeking a talented Senior Specialist to join our Clinical Quality Assurance team.Position DescriptionWe're looking for a...
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Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our diagnostic tests, and we're seeking a talented Senior Specialist to join our Clinical Quality Assurance team.Position DescriptionWe're looking for a...
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Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're on a mission to make a real difference in science and healthcare. Our team is passionate about driving innovation and continuous improvement, and we're looking for talented individuals to join us. As a Senior Specialist, Clinical Quality Assurance, you'll play a key role in ensuring the quality and compliance of our clinical affairs...
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Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're on a mission to make a real difference in science and healthcare. Our team is passionate about driving innovation and continuous improvement, and we're looking for talented individuals to join us. As a Senior Specialist, Clinical Quality Assurance, you'll play a key role in ensuring the quality and compliance of our clinical affairs...
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Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our clinical affairs, and we're seeking a talented Senior Specialist to join our Manchester Quality Assurance team.Position DescriptionThe successful...
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Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our clinical affairs, and we're seeking a talented Senior Specialist to join our Manchester Quality Assurance team.Position DescriptionThe successful...
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Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our clinical affairs, and we're seeking a talented Senior Specialist to join our Manchester Quality Assurance team.Position DescriptionThe successful...
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Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our diagnostic tests, and we're seeking a talented Senior Specialist to join our Clinical Quality Assurance team.Position DescriptionWe're looking for a...
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Senior Specialist, Clinical Quality Assurance Expert
2 months ago
Manchester, United Kingdom QIAGEN Full timeAbout the RoleWe are seeking a highly skilled Senior Specialist, Clinical Quality Assurance to join our QIAGEN Manchester Quality Assurance team. As a key member of our team, you will be responsible for ensuring the quality and compliance of clinical trials, including the testing and registration of diagnostic tests.Key ResponsibilitiesCollaborate with the...
-
Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our clinical affairs, and we're seeking a talented Senior Specialist to join our Manchester Quality Assurance team.Key ResponsibilitiesCollaborate with the...
-
Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our clinical affairs, and we're seeking a talented Senior Specialist to join our Manchester Quality Assurance team.Key ResponsibilitiesCollaborate with the...
-
Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our clinical affairs, and we're seeking a talented Senior Specialist to join our Manchester Quality Assurance team.Position DescriptionThe successful...
-
Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our clinical affairs, and we're seeking a talented Senior Specialist to join our Manchester Quality Assurance team.Position DescriptionThe successful...
-
Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our clinical affairs, and we're seeking a talented Senior Specialist to join our Manchester Quality Assurance team.Position DescriptionThe successful...
-
Manchester, United Kingdom QIAGEN Full timeOverviewAt QIAGEN, we're driven by a passion for innovation and a commitment to making a real difference in science and healthcare. Our team is dedicated to ensuring the highest quality and compliance in our clinical affairs, and we're seeking a talented Senior Specialist to join our Manchester Quality Assurance team.Position DescriptionThe successful...
