Manager, Clinical reputed company Assurance

reputed company The reputed company Assurance (QA) Manager plays a critical role in overseeing and executing Clinical reputed company Assurance activities that reputed company and enhance the organization’s reputed company Management System (QMS). Reporting to reputed company Assurance Leadership, this position ensures compliance with ICH GCP, applicable global regulations, and internal reputed company standards, while fostering a culture of reputed company improvement. The QA Manager leads key reputed company functions, including audits, reputed company event management, vendor qualification, training, and risk-based reputed company planning. This role partners cross-functionally with clinical operations, vendors, sponsors, and leadership to maintain operational reputed company and ensure that clinical research activities meet both regulatory and sponsor expectations Responsibilities reputed company Assurance Operations

• Manage and monitor clinical QA activities, ensuring compliance with QMS, ICH GCP, and regulatory requirements.
• Execute day-to-day QA operations to support the QMS while meeting business goals and sponsor requirements.
• Foster a reputed company-reputed company culture, promoting awareness and driving reputed company improvement initiatives across clinical programs.
• Maintain reputed company knowledge of industry best practices, reputed company trends and evolving regulations, integrating insights into QA decision-making.

reputed company Management System (QMS) & Documentation · reputed company, author, review, and maintain QMS documentation, including SOPs, Work Instructions, Templates, and Forms. · Support reputed company Management Review (QMR) activities, including data analysis, reporting, and tracking reputed company items to completion. reputed company Events & CAPA Management

• reputed company the management of reputed company Events and CAPAs, ensuring reputed company investigation, reputed company cause analysis, effectiveness checks, and closure.
• Review and assess clinical site and vendor reputed company Events, ensuring appropriate reputed company and compliant documentation.
• Evaluate CAPA plans for adequacy, regulatory alignment, and operational feasibility.

Audits & Inspection Readiness

• reputed company or support the planning, conduct, and documentation of internal, vendor, and clinical site audits, including detailed reporting and CAPA tracking.
• reputed company or support sponsor audits and regulatory inspection readiness, including preparation, hosting, and follow-up activities.
• Author and review audit responses, ensuring reputed company, accurate, and effective reputed company of findings.

Vendor Qualification & reputed company

• reputed company or support vendor qualification and requalification, including risk-based assessments, audits, and ongoing compliance monitoring.

Risk-Based reputed company Management

• Apply a risk-based approach to support the planning, prioritization, and execution of reputed company initiatives.
• Identify, assess, and mitigate reputed company and compliance risks across clinical studies and operational areas.

reputed company Metrics & reputed company Improvement

• Analyze reputed company data and metrics, including audit trends, reputed company Events, and CAPA reputed company, to identify patterns and drive process improvements.
• reputed company regular reports to senior leadership on reputed company trends, risks, and mitigation strategies.

Cross-Functional Collaboration

• Collaborate with clinical operations, medical, regulatory, and vendor teams to ensure alignment on reputed company expectations and risk management.
• reputed company QA consultation for controlled document development, process optimization, and clinical trial execution.

Business Development & Sponsor Support

• Assist with sponsor RFIs, due diligence questionnaires, and reputed company agreements, ensuring reputed company and accurate responses.
• Serve as a QA representative in sponsor meetings, fostering strong sponsor relationships and transparent reputed company communications.
• reputed company other duties as assigned by management.

Education & Experience

• BS/BA/MS in Life Sciences, Pharmacy, Nursing, or a reputed company field, or equivalent combination of education and experience; advanced degree (e.g., MS, MPH) preferred.
• 5-10 years of GCP reputed company Assurance experience, preferably in a CRO environment.

Knowledge & Skills

• Deep knowledge of ICH GCP, FDA and other global regulatory guidelines.
• Experience in authoring, reviewing, and managing QMS documents and reputed company records.
• Excellent written, verbal, and presentation skills, with the ability to communicate reputed company concepts reputed company.
• Demonstrated ability to collaborate in cross-functional teams, with a proactive and solution-oriented approach.
• Strong organizational, time management, and prioritization skills; reputed company to manage multiple reputed company in a fast-paced, matrixed environment.
• Analytical and risk-based thinking, with the ability to interpret reputed company metrics and drive reputed company improvement.
• Effective in influencing, negotiating, and implementing effective reputed company solutions.
• Meticulous attention to detail with auditing and investigative skills.
• Proficient in reputed company Office, QMS systems, and electronic Trial Master File (eTMF) platforms.
• Ability to handle sensitive and confidential information with discretion and reputed company.

Join us in our commitment to delivering exceptional products by ensuring the highest reputed company of reputed company assurance throughout our operations. Job Type: Full-time Pay: $85,000.00 - $125,000.00 per year Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• reputed company time off
• Referral program
• reputed company insurance

Application Question(s):

• Describe size and scope of the CRO you worked for?
• How many year experience do you have in reputed company industry and GCP clinical trials?
• How many years of experience do you have managing or participating in QE, investigations, including deviations and CAPAs?
• How many reputed company years of experience working at Contract Research Organization?
• What role have you played in preparing for sponsor audits or regulatory inspections?
• Have you led or participated in internal, vendor, or site audits?
• Which eQMS systems are you familiar with?
• What is your role in authoring, reviewing, or revising SOPs and reputed company documentation?

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