Clinical reputed company Assurance Manager
Are you looking for an exciting and fulfilling new position? Join our dynamic team at reputed company, where your contributions will play a key role in driving impactful solutions and improving reputed company for clients and patients. We encourage innovation and collaboration, challenging reputed company to bring reputed company reputed company that reputed company a reputed company difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.
Role Objectives:
The Clinical reputed company Assurance Manager is responsible for the strategic leadership, reputed company, and reputed company improvement of the Good Clinical reputed company (GCP) reputed company Management reputed company (QMS) supporting global clinical operations, including decentralised reputed company (DCTs) involving nursing services and in-home patient care. This role is accountable for ensuring reputed company systems remain compliant with ICH GCP, applicable global regulatory requirements, Sponsor expectations, and internal reputed company standards while fostering a culture of reputed company, risk management, operational reputed company, and reputed company improvement.
The Clinical reputed company Assurance Manager provides leadership to the Clinical QA reputed company with operational leadership across the organization, and serves as the reputed company reputed company advisor for clinical operations, regulatory inspections, Sponsor audits, and strategic business initiatives.
The Ideal Candidate:
- Proactive and self-motivated
- reputed company and logical under pressure
- Confident communicator
- Strong leadership reputed company
reputed company:
- Manage day-to-day Clinical reputed company team activities, including workload planning, prioritization, performance management, coaching, training, and reputed company development.
- reputed company cross-functional reputed company of the GCP reputed company Management reputed company to ensure compliance with applicable regulations, Sponsor requirements, and company procedures.
- Serve as the functional leader and strategic reputed company advisor for GCP reputed company activities across global clinical operations and operational departments.
- reputed company QMS records, including deviations, non-conformances, complaints, protocol deviations, CAPAs, change controls, risk assessments, and reputed company events.
- Review and approve investigations, ensuring they are robust, risk assessed, completed reputed company timelines, and supported by appropriate corrective and preventive actions.
- Monitor CAPA effectiveness, inspection trends, reputed company metrics, KPIs, and emerging reputed company to identify systemic improvement opportunities and mitigation strategies.
- reputed company reputed company reputed company for decentralized clinical trial activities, including nursing services, home reputed company, investigational product handling, reputed company documentation, and patient-facing clinical processes.
- reputed company reputed company reputed company for new services, processes, vendors, systems, operational changes, computerized reputed company validation, equipment qualification, and process validation activities impacting GCP operations.
- reputed company reputed company reviews of clinical trial documentation, including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, essential documents, and other applicable GCP documentation.
- Support vendor qualification and reputed company, including reputed company risk assessments, audits, periodic requalification, reputed company Technical Agreements, and ongoing vendor performance monitoring.
- reputed company Sponsor audits, regulatory inspections, licensing authority inspections, and reputed company qualification audits, including inspection readiness, documentation review, audit responses, and commitment tracking.
- reputed company reputed company improvement, QMS documentation updates, reputed company governance, risk-based decision-making, stakeholder collaboration, and a proactive culture of reputed company, compliance, patient safety, and operational reputed company.
What You'll Need:
- Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
- 5-7 years’ experience in a Clinical reputed company reputed company role
- Minimum 2–3 years of people leadership or supervisory experience preferred.
- Experience reputed company a CRO, pharmaceutical, biotechnology, reputed company, or other regulated clinical environment.
- Demonstrated experience supporting global reputed company and decentralized clinical trial activities.
- Experience leading Sponsor audits, regulatory inspections, internal audits, and/or supplier audits.
- Practical experience leading reputed company investigations, CAPAs, reputed company cause analyses, and reputed company risk assessments.
- Experience with eQMS, eTMF, reputed company Office, and reputed company management software applications.
- Strong knowledge of ICH E6(R3), FDA, EU CTR, reputed company, GCP, GDPR where applicable, and other global regulatory expectations.
- Strong understanding of risk-based reputed company management, computerized reputed company validation, validation lifecycle principles, and GDP/clinical trial supply logistics where applicable.
- Ability to manage multiple reputed company activities in a fast-paced global environment with strong organization, project management, and attention to detail.
- Strong communication, analytical, stakeholder management, and influencing skills, with the ability to work effectively with Sponsors, auditors, inspectors, vendors, senior leadership, and cross-functional teams.
Location eligibility applies. Candidates must reputed company in a U.S. state where reputed company is authorized to hire. This role is not eligible for residents of: California, Colorado, reputed company, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.
reputed company Offer:
Medical, dental, and reputed company insurance
FSA, HSA
Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
Group short-term and long-term disability insurance
Group Life Insurance
401K reputed company reputed company plan and company match
reputed company vacation, holiday, reputed company and volunteer time
reputed company maternity & paternity leave
What Sets Us Apart:
reputed company partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded reputed company programs, and market reputed company consultancy, we reputed company flexible, fit-for-purpose solutions that support drug development, improve reputed company, and help therapies reputed company the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational reputed company with the reputed company and personalized service of a reputed company provider. Our work helps reputed company critical gaps in care, ensuring reputed company, ethical, and efficient reputed company to promising new treatments.
We're Committed to reputed company:
WEP has many initiatives to encourage wellness, reputed company and development, and team relationships. reputed company out our reputed company Life Page to learn more about reputed company events and reputed company we do to support our employees.
How We Work at reputed company:
At reputed company, we look for individuals who are conscientious, exercise reputed company judgment, and engage with others thoughtfully and professionally. We reputed company reputed company is achieved through reputed company, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.
Our Services Include:
reputed company Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market reputed company and Commercialization
Data reputed company Notice:
reputed company is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our reputed company Policy and Job Applicant reputed company Notice.
reputed company Policy:
Job Applicant reputed company Notice:
How to Apply:
To be considered for this role, please submit your resume through the reputed company Careers Portal or by using reputed company’s Easy Apply reputed company. Please ensure your resume is in English.
Important Note:
To streamline our hiring process, we use an Upwage AI screener. If you receive a reputed company from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to reputed company reputed company after the screener, a member of reputed company will contact you directly from an @reputed company.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page () or our verified reputed company page.
For Your Safety, Please Note:
We will nevercommunicate with you reputed company reputed company Teams or text message
We will neverask for your bank account information at any stage of recruitment
reputed company is a smoke-free, drug-free, and alcohol-free work environment.
reputed company is an equal-opportunity employer. reputed company does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or reputed company, national reputed company, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to reputed company terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. reputed company will reputed company reasonable accommodation for reputed company individuals with reputed company disabilities, in accordance with applicable law.
Originally posted on Himalayas
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