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ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
quality assurancecomplianceauditingGCPCAPAQuality Management Systemsstandard operating proceduresprocess improvementpharmaceutical regulatory requirementsbiotechnology regulatory requirements
Soft Skills
verbal communicationwritten communicationinterpersonal skillsrelationship buildingplanninganalysisproblem solvingorganizational skillstime managementmanagerial experience
Tools & Technologies
Microsoft Office SuiteSharePointelectronic Document Management SystemLearning Management Systemaudit scheduling toolsBoxGQC IT systemsinternal trackersaudit calendartraining documentation
Industry Keywords
CROICHGxPFDA/CFREMAMHRAEU GVPregulatory inspectionsclient auditscontrolled documents lifecycle
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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