Manager, GQC Support

This is a fully remote position, open to applicants in United States.

📋 Description

• Manage and supervise the lifecycle of controlled documents along with the associated test assessments.

• Ensure adherence to internal policies and procedures, maintaining the targeted review cycle frequency and proper formatting of SOP documents.

• Assist in the SOP review and approval process as necessary.

• Oversee and coordinate training-related activities, including the SOP table of contents, training matrix, training materials, and other documentation.

• Provide support for CAPA administrative tasks such as data entry, effectiveness checks, process enhancements, and ensuring compliance with policies and procedures.

• Assist with the maintenance and change control of GQC IT systems, including CAPA and electronic Document and Learning Management Systems.

• Manage the functions related to Regulatory/Client Audit Support.

• Schedule audits and maintain the audit calendar.

• Coordinate meeting logistics.

• Handle CDA Requests.

• Uphold the Auditor Code of Conduct.

• Establish internal trackers and portals for tracking purposes.

• Set up and provide secure Box access for auditors as needed.

• Review Quality Compliance documentation prior to and during audits.

• Ensure audit reports and responses are stored according to UBC record retention policies.

• Provide administrative assistance (such as agendas, minutes, and metrics) for the Global Quality Compliance department.

• Support department-related special projects.

• Perform other duties as assigned.

⛳️ Requirements

• Bachelor’s degree is required, preferably in Life Sciences, Clinical, or Business disciplines.

• A minimum of 5 years of experience in quality assurance, compliance, or auditing within a GCP environment.

• Previous experience working in a Contract Research Organization (CRO).

• Experience in hosting regulatory inspections and supporting client audits.

• At least 5 years of GCP experience is required.

• In-depth knowledge of relevant pharmaceutical and biotechnology regulatory requirements (e.g., ICH, GCP, GxP, FDA/CFR, EMA, MHRA, EU GVP).

• Ideally, at least 1 year of prior managerial or supervisory experience, including managing teams and/or staff.

• Required proficiency in PC applications, including the Microsoft Office Suite (i.e., Word, Excel, PowerPoint, Outlook), Internet, and SharePoint.

• Experience in managing the lifecycle of corrective and preventive actions (CAPA).

• Familiarity with Quality Management Systems maintenance.

• Experience managing standard operating procedures (SOPs) and policies.

• Experience in implementing and managing process improvements.

• Exceptional verbal presentation and written communication skills.

• Proven ability to build interpersonal relationships.

• Strong planning, analytical, and creative problem-solving skills.

• Excellent organizational and time management abilities.

• Preferred experience in software application development and maintenance.

🏝️ Benefits

• Competitive salaries.

• Opportunities for career advancement.

• 401K plan with company matching.*

• Tuition reimbursement programs.

• Flexible working environment.

• Discretionary Paid Time Off (PTO).

• Paid holidays.

• Employee assistance programs.

• Medical, dental, and vision coverage.

• Health Savings Account (HSA) and Flexible Spending Account (FSA).

• Telemedicine services (virtual doctor appointments).

• Wellness programs.

• Adoption assistance.

• Short-term and long-term disability coverage.

• Life insurance options.

• Discount programs.