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Director, External Quality
MSDLead a team ensuring compliance and oversight across external manufacturing. Representing a global healthcare company to drive quality and process improvements in the Pharmaceutical and Medical Device industry.
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 SystemsQuality AssuranceQuality ControlMDCPsregulatory inspectionscompliance oversightcontinuous improvementmanufacturing quality systemsexternal manufacturing managementcross-functional initiatives
Soft Skills
interpersonal skillscommunication skillscoaching skillsmotivation skillsnegotiation skillspersuasion skillsrelationship buildingleadership skillscollaborationeffectiveness improvement
Industry Keywords
Pharmaceutical industryMedical Device industrydomestic regulationsforeign regulationsplant operationsregulatory expectationsquality managementexternal forumstechnical disciplinequality oversight
About the role
Key responsibilities & impact- Leading a team of quality professionals ensuring compliance and quality oversight across external manufacturing of products and devices
- Subject matter expert in EQA and manufacturing quality systems, technology platforms, regulatory expectations, and external manufacturing management
- Represent the company in external forums
- Lead complex cross-functional initiatives to optimize quality and business processes driving continuous improvement
- Act as a subject matter expert for both EQA and the manufacturing division in specific Quality Systems
- Collaborate with other functions to continuously improve effectiveness and efficiency in quality management and quality systems
Requirements
What you’ll need- Minimum four-year degree in Science, Engineering, or other relevant technical discipline
- Minimum of 12 years relevant experience in the Pharmaceutical and/or Medical Device industry
- Thorough knowledge of Quality Systems, Quality Assurance, and Quality Control
- Good knowledge and experience with MDCPs
- Strong interpersonal, communication, coaching, motivation, negotiation, and persuasion skills
- Ability to work across boundaries; demonstrated interpersonal, relationship building, and leadership skills
- Proficiency in English, both verbally and in writing
- Previous experience participating in regulatory inspections
- Familiarity with domestic and foreign regulations and compendia governing plant operations
Benefits
Comp & perks- Flexible working where possible
- Hybrid working model for office-based colleagues