Senior Quality Manager
West Pharmaceutical Services
full-time
Posted on:
Location Type: Office
Location: Cidra • 🇵🇷 Puerto Rico
Visit company websiteJob Level
Senior
About the role
- Responsible for providing quality leadership, governance, and expertise in Quality Assurance processes
- Ensure compliance to regulatory requirements and West procedures
- Proactively develop, lead, and drive the execution of the Quality Assurance strategy
- Develop and implement quality assurance plans ensuring compliance with regulations
- Oversee interactions with regulatory agencies and build strong relationships with stakeholders
- Champion advocacy for product, process, and system quality
- Drive continuous improvement within the Quality Management System
- Cultivate positive working relationships with internal and external stakeholders
- Accountable for the development of the quality assurance plans and systems
- Oversee regulatory agency interaction related to compliance
- Develop and champion a quality/patient-first organizational culture
- Responsible for ensuring QA resources have adequate training
- Responsible for developing a culture of risk activities
- Coach, mentor and lead team members
Requirements
- Bachelor's Degree in Engineering or related disciplines required
- Minimum 10 years related experience required
- Previous leadership experience preferred
- Experience in regulated industry such as pharmaceutical and medical device preferred
- Project Management experience preferred
- Strong knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, and ISO9001
- Familiarity with document management databases, particularly MasterControls and SAP
- Proven ability to manage multiple priorities
- Ability to effectively communicate with co-workers and business partners at all levels
- Excellent organizational skills
- Working knowledge of statistical data analysis
- Thorough understanding of validation activities and risk management principles
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Professional development
- Wellness programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Assuranceregulatory compliancequality assurance plansstatistical data analysisvalidation activitiesrisk management principlesproject managementISO13485ISO9001FDA 21 CFR Part 820
Soft skills
leadershipcommunicationorganizational skillsrelationship buildingcoachingmentoringcontinuous improvementadvocacyteam developmentprioritization
Certifications
Bachelor's Degree in Engineering