Strategic Quality Assurance Leader for Clinical Trial Delivery
Vor 4 Tagen
We are seeking a highly experienced Strategic Quality Assurance Leader to oversee the clinical trial delivery quality systems at Takeda. This individual will provide quality oversight, promote operational and compliance excellence, and maintain a state of control by implementing monitoring and control systems aligned with applicable regulations.
Key Responsibilities- Partner with various functions to identify systemic quality and compliance risks, conduct investigations, and develop adequate corrective and preventive actions (CAPAs), manage changes, and facilitate improvement that considers Takeda's values and priorities.
- Lead the clinical trial delivery system inspection readiness program, including strategy implementation. Engage with relevant responsibilities and partners to ensure inspection readiness, drive accountability, and transparency. Functions include Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, and Legal.
- Provide insights into the latest requirements, operational and compliance metrics, and storyboards; identify quality and compliance inspection risks, and provide tactical directions in mitigation.
- Host GCP inspections and provide strategic direction to relevant responsibilities and Subject Matter Experts (SMEs).
- Evaluate the effectiveness of the inspection response activities, ensuring responses are adequate, reviewed, and approved internally by relevant partners at the right levels and submitted on time. Provide input to ensure the impact is thoroughly assessed, appropriate cause is identified, and measurable, achievable, time-bound CAPAs are developed.
- Oversight of completed and closed inspection CAPAs, ensuring no inspection CAPAs are late, mitigating and escalating any risks. Develop appropriate effectiveness checks for relevant inspection CAPAs, providing input to effectiveness check plans, and reviews/approving outcomes.
- Serve as a Subject Matter Expert (SME) on Clinical Quality Compliance activities, including deviation management, quality investigation, CAPA management, and oversight, and change control. Represent Clinical Quality Compliance in these topics during inspections.
- Support and provide guidance on non-GCP specific inspections (e.g., GVP, GMP).
- Conduct complex quality investigations, improving the clinical trial delivery systems. Provide Quality Leadership for other quality investigations, ensuring engagement of the right partners in impact assessment, root cause analysis, and CAPA development.
- Analyze results, quality issues, and investigations to identify applicable trends and promote a state of compliance.
- Develop and monitor relevant metrics and Key Performance/Quality Indicators (KPI/KQI). Mitigate, communicate, and escalate any risks flagged by metrics/KQIs, ensuring actions are commensurate to the risk and timely. Drive the development and execute the strategy to understand the health of the clinical trial delivery quality system.
- Contribute to quality and compliance governance in Takeda, including the Clinical & Safety Quality Council, communicating quality or compliance risks and opportunities, continual improvements, and successes.
Takeda is transforming patient care through novel specialty pharmaceuticals and best-in-class patient support programs. We foster an inclusive, collaborative workplace where our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
What You Bring- BSc in a scientific or allied health/medical field (or equivalent degree)
- Minimum 10 years of increasing responsibility and relevant experience in global pharmaceutical industry functions such as Clinical Operations, Data Management and Statistics, with at least 5 years of experience in GCP Quality/Compliance
- Experience with pharmaceutical development, medical affairs, and GCP/GVP regulations, including FDA, EU, MHRA, PMDA, and ICH
- Successful implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, and remediation activities on a global level
- Experience managing complex organizational compliance issues and implementing organization-wide compliance projects
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including qualifications, years of relevant experience, unique skills, level of education, certifications, and location.
-
Zürich, Zürich, Schweiz Takeda VollzeitAbout the Role:As a key member of our Clinical Quality Compliance team, you will play a critical role in ensuring the quality and integrity of our clinical trials. You will be responsible for providing quality oversight to our clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and knowledge...
-
Clinical Trials Attorney
vor 4 Wochen
Zürich, Zürich, Schweiz Axiom VollzeitWe are seeking a skilled Clinical Trials Lawyer to work with Axiom clients across various industries in Switzerland.Key Responsibilities:Provide legal advice and counsel on clinical trial activities, research and development, and related matters.Draft, review, and negotiate clinical trial agreements, clinical supply agreements, and informed consent...
-
Clinical Trials Attorney
vor 6 Stunden
Zürich, Zürich, Schweiz Axiom VollzeitWe are currently seeking experienced Clinical Trials Attorneys to work with Axiom clients across various industries in Switzerland.A competitive compensation package is offered, including a salary range of $120,000 - $180,000 per year, depending on experience, plus a benefits package that includes medical, dental, and more. Our remote work policy allows for...
-
Clinical Trials Attorney
vor 2 Wochen
Zürich, Zürich, Schweiz Axiom VollzeitAxiom is seeking a Clinical Trials Lawyer to work with various clients across all industries in Switzerland.Responsibilities:Provide counsel on legal matters pertaining to Clinical Trial Activities, Research & Development, and related activities.Draft, review, and negotiate clinical trial agreements, supply agreements, and informed consent documentation with...
-
Clinical Trials Attorney
vor 3 Wochen
Zürich, Zürich, Schweiz Axiom VollzeitWe are seeking highly skilled Clinical Trials Lawyers to join our team at Axiom, working with clients across various industries in Switzerland.Responsibilities:Provide expert guidance on legal matters related to clinical trials, research and development, and associated activities.Draft, review, and negotiate clinical trial agreements, supply agreements, and...
-
Quality Assurance Specialist
vor 3 Wochen
Zürich, Zürich, Schweiz Michael Page VollzeitQuality Assurance Role at Michael PageThe Quality Assurance Engineer at Michael Page plays a crucial role in ensuring the quality of our products and services. This position focuses on leading quality improvement projects using statistical tools and problem-solving methods to meet our client's quality standards.Implement and enforce policies, procedures, and...
-
Regulatory Compliance Expert
vor 5 Stunden
Zürich, Zürich, Schweiz Takeda VollzeitAbout This RoleThis position is responsible for ensuring that clinical trials are conducted in compliance with regulatory requirements and company policies. The Associate Director, Clinical Quality Compliance will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk...
-
Quality Assurance Specialist
vor 1 Monat
Zürich, Zürich, Schweiz Michael Page VollzeitQuality Assurance EngineerThe Quality Assurance Engineer plays a pivotal role in driving quality improvement initiatives, leveraging statistical tools and problem-solving methodologies to meet stringent quality standards. This position requires a strong technical background, with a focus on ensuring credibility across the organization.Key...
-
Quality Assurance Specialist for Technical Projects
vor 3 Wochen
Zürich, Zürich, Schweiz coni+partner AG Vollzeit**Job Description**We are seeking a skilled Quality Assurance Specialist to join our team at Company.The Quality Assurance Specialist will be responsible for ensuring the quality and integrity of technical projects. This includes developing and implementing quality assurance processes, conducting regular audits, and providing feedback to project teams.Key...
-
Lead Software Quality Assurance Specialist
vor 6 Stunden
Zürich, Zürich, Schweiz Fluence VollzeitFluence, a cutting-edge energy storage solutions company, is seeking an experienced Lead Software Quality Assurance Specialist to join its dynamic software engineering team. The ideal candidate will have 5-8 years of professional experience in software quality assurance and testing.About the PositionThis role offers a unique opportunity to work on the...
-
Senior Clinical Supply Chain Manager
vor 2 Wochen
Zürich, Zürich, Schweiz Merck Sharp & Dohme (MSD) VollzeitJob DescriptionWe are seeking an experienced Senior Clinical Supply Chain Manager to join our team in Beijing. This is a full-time position, and the salary range for this role is between $120,000 and $180,000 per annum.About UsMERCK SHARP & DOHME (MSD) is a leading global healthcare company with a rich history of innovation. We strive to improve human lives...
-
Quality Assurance Specialist
vor 4 Wochen
Zürich, Zürich, Schweiz Michael Page VollzeitMichael Page is seeking a Quality Assurance Specialist to join their team in a temporary assignment for the next 12 months.The ideal candidate will have a strong background in quality system improvement and process design, with expertise in GMP regulations (ISO22716, FDA, KFDA) and OTC manufacturing knowledge.The selected candidate will provide technical...
-
Quality Assurance Specialist
vor 3 Wochen
Zürich, Zürich, Schweiz Vebego AG VollzeitWe are seeking a skilled Quality Assurance Specialist to join our team at {company}. The ideal candidate will have a keen eye for detail and a strong understanding of software development principles.The Quality Assurance Specialist will be responsible for:Ensuring high-quality software products by identifying and reporting defects and issuesCollaborating...
-
Strategic Procurement Lead
vor 2 Wochen
Zürich, Zürich, Schweiz Mandarin Oriental Savoy, Zurich VollzeitOverviewThe Mandarin Oriental Savoy, Zurich is a luxurious hotel located in the heart of the city, offering a unique blend of tradition and modernity. As a Strategic Procurement Lead, you will be part of a dynamic team that strives to deliver exceptional service to our guests.Job DescriptionWe are seeking an experienced Strategic Procurement Lead to join our...
-
Zürich, Zürich, Schweiz RUAG VollzeitAre you passionate about leading the entire lifecycle of product development and quality assurance for cutting-edge satellite projects?**About Beyond Gravity**Beyond Gravity is a unique blend of agility, speed, and innovation, fusing a start-up mindset with decades of industry expertise and a track record of 100% mission success. Our dynamic team of over...
-
Quality Assurance Specialist
vor 4 Wochen
Zürich, Zürich, Schweiz Michael Page VollzeitQuality Assurance Engineer Job DescriptionAt Michael Page, we are seeking a highly skilled Quality Assurance Engineer to join our team on a temporary assignment basis. This role offers an excellent opportunity to work with a leading international player in the consumer goods industry, with a focus on quality improvement and regulatory compliance.Key...
-
Quality Assurance Engineer
vor 3 Wochen
Zürich, Zürich, Schweiz Equans Switzerland AG VollzeitJob SummaryWe are seeking a skilled Quality Assurance Engineer to join our team. The successful candidate will be responsible for ensuring the quality of our software products.Key Responsibilities:Develop and implement quality assurance processes and proceduresConduct testing and validation of software productsIdentify and report defects and...
-
Project Quality Assurance Specialist
vor 4 Wochen
Zürich, Zürich, Schweiz Kanadevia Inova VollzeitWelcome to Kanadevia Inova, a global innovation leader in the waste infrastructure space, where we believe in creating a sustainable future through technology and innovation.Transforming Waste into ValueAt Kanadevia Inova, we pride ourselves on being at the forefront of waste-to-X technology. We are not just waste managers; we are creators of value from what...
-
Strategic Medical Excellence Lead
vor 2 Wochen
Zürich, Zürich, Schweiz Takeda VollzeitJob Summary:The Associate Director - Global Medical Excellence Lead will be responsible for partnering with Takeda business units to drive strategic and operational alignment of Medical Excellence programs. This role will ensure the successful development and execution of training designed to build functional skills and behaviors that meet the evolving...
-
Project Quality Assurance Manager
vor 4 Wochen
Zürich, Zürich, Schweiz Kanadevia Inova VollzeitWelcome to Kanadevia Inova, a global leader in waste infrastructure solutions. We believe in creating a sustainable future through innovation and technology.At Kanadevia Inova, we are pioneers in transforming waste into value. As a key member of our team, you will play a crucial role in turning waste into energy, heat, hydrogen, fertilizer, and more.As the...
