Manager, Clinical Quality Assurance

Overview

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

Responsibilities

Quality 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 quality-focused culture, promoting awareness and driving reputed company improvement initiatives across clinical programs.
• Maintain reputed company knowledge of industry best practices, quality trends and evolving regulations, integrating insights into QA decision-making.

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

• reputed company the management of Quality Events and CAPAs, ensuring timely investigation, root cause analysis, effectiveness checks, and closure.
• Review and assess clinical site and vendor Quality Events, ensuring appropriate resolution 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 timely, accurate, and effective resolution 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 Quality Management

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

Quality Metrics & reputed company Improvement

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

Cross-Functional Collaboration

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

Business Development & Sponsor Support

• Assist with sponsor RFIs, due diligence questionnaires, and quality agreements, ensuring timely and accurate responses.
• Serve as a QA representative in sponsor meetings, fostering strong sponsor relationships and transparent quality 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 Quality 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 quality records.
• Excellent written, verbal, and presentation skills, with the ability to communicate reputed company concepts clearly.
• Demonstrated ability to collaborate in cross-functional teams, with a proactive and solution-oriented approach.
• Strong organizational, time management, and prioritization skills; able to manage multiple projects in a fast-paced, matrixed environment.
• Analytical and risk-based thinking, with the ability to interpret quality metrics and drive reputed company improvement.
• Effective in influencing, negotiating, and implementing effective quality 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 levels of quality 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
• Paid time off
• Referral program
• Vision insurance

Application Question(s):

• Describe size and scope of the CRO you worked for?
• How many year experience do you have in Pharma 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 direct 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 quality documentation?

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