Manager, GQC Support
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Job Description
Manager Global Quality Compliance Support at UBC overseeing quality management and audit support. Requires extensive GCP experience and leadership in compliance auditing.
Responsibilities:
- Oversee and manage the controlled documents lifecycle and corresponding test assessments
- Ensure compliance with internal policies and procedures and target review cycle frequency including appropriate formatting of SOP documents
- Support SOP review and approval process as deemed appropriate
- Oversee and manage training related activities (e.g. SOP table of content, training matrix, training decks, other training documentation)
- Oversee and provide assistance with CAPA administrative activities (data entry, effectiveness checks, process improvement, ensure process is managed in compliance with policies and procedures, etc.)
- Support and assist with GQC IT systems maintenance and change control (CAPA, electronic Document and Learning Management System, other)
- Oversee and manage the Regulatory/Client Audit Support functions
- Audit scheduling and audit calendar maintenance
- Meeting coordination/logistics
- CDA Requests
- Auditor Code of Conduct
- Setting up internal trackers and portals
- Setting up and providing secure Box access for auditor(s) when required
- Quality Compliance documentation review prior to and during audit
- Ensure audit reports and responses are stored as per UBC record retention procedures
- Provide administrative support (i.e., agenda, minutes, metrics) for the Global Quality Compliance department
- Assist in department-related special projects
- Other duties as assigned
Requirements:
- Bachelor’s degree required preferably in Life Sciences, Clinical, or Business area of study
- 5 years quality assurance/compliance/auditing experience within a GCP environment
- Previous experience of working at a CRO
- Experience hosting regulatory inspections and supporting client audits
- Minimum of 5 years GCP experience
- Extensive knowledge of applicable pharmaceutical/biotechnology regulatory requirements (e.g., ICH, GCP, GxP, FDA/CFR, EMA, MHRA, EU GVP)
- Preferably at least 1 year of previous managerial/supervisory experience (i.e., experience managing teams and/or staff)
- Proficient PC knowledge required including Microsoft Office Suite (i.e., Word, Excel, Powerpoint, Outlook), Internet, SharePoint
- Experience in management of the corrective and preventive action (CAPA) lifecycle
- Experience in Quality Management Systems maintenance
- Experience in management of standard operating procedures (SOPs)/policies
- Experience in implementation and management of process improvement
- Excellent verbal presentation and written communications skills
- Proven interpersonal and relationship building skills
- Proven skills in planning, analysis, and creative problem solving
- Strong organizational and time management skills
- Preferred exposure to software application development and maintenance
Benefits:
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match*
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (Paid Time Off)
- Paid Holidays
- Employee assistance programs
- Medical, Dental, and vision coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs
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