FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Quality Management Systems (QMS) with a strong focus on regulatory compliance, including ISO9001:2015 and ISO 13485:2016 standards. Proven ability to lead quality improvement initiatives, conduct audits, and manage corrective and preventive actions (CAPA) effectively.
Highest-signal resume keywords
Quality Management System (QMS)ISO 13485:2016 CertificationCorrective And Preventive Actions (CAPA)Regulatory ComplianceProject Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Analytical SkillsData InterpretationStandard Operating Procedures (SOP) ManagementAudit ActivitiesIssue Review Processes
Soft Skills
Cross-Functional Team CollaborationTraining FacilitationProblem-Solving
Certifications & Qualifications
ISO 13485 Internal Auditor CertificationGDPMD Internal Auditor Certification
Industry Keywords
PharmaceuticalQuality ComplianceISO 9001:2015Good Distribution Practice (GDP)Good Distribution Practice for Medical Devices (GDPMD)
About the role
Key responsibilities & impact- Support implementation, monitoring and improvement of the local Quality Management System (QMS) with regulatory compliance
- Prepare, review, update, track, implement and monitor standard operating procedures
- Support deployment of corporate policy to the country local QMS
- Provide regulatory and compliance guidance on operational activities, including customer complaints handling and supplier/subcontractor management
- Support internal, external, supplier and regulatory audit activities
- Participate in CAPA board meetings and ensure corrective and preventive actions meet requirements
- Support quality compliance improvement programs and projects
- Improve internal control and governance practices with management
- Serve as the country point of contact for quality compliance matters
- Conduct and support training activities for cross-functional teams
- Support regional Quality Compliance leadership with country improvement projects
- Issue CAPA based on audit findings and follow through to closure
- Ensure CAPA effectiveness
- Conduct and support Field Corrective Action activities
- Plan and conduct regular audits of subcontractor activity
- Establish processes for Issue Review and Escalation to the division
- Lead Identify and Assess steps within Issue Review and document and obtain approvals
- Investigate issues during issue review
- Perform other duties as determined by management
Requirements
What you’ll need- Bachelor’s degree in Pharmaceutical, Pharmacy or Science or equivalent
- Analytical skill and ability to interpret information and data for routine operational needs
- Good understanding of ISO9001:2015, ISO 13485:2016 or GDP/GDPMD
- Minimum 2-5 years’ experience in Quality function
- Certified ISO 13485 or GDPMD internal auditor is preferred
- Experience with project management is preferred
- Ability to work in a hybrid arrangement
- May include up to 5% domestic travel
Benefits
Comp & perks- Programs supporting employees’ physical and financial well-being
- Compensation and benefits regularly benchmarked with companies of comparable size and scope
- Hybrid working arrangement combining office-based work with remote work from home
- Up to 5% domestic travel