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About the role
Key responsibilities & impact- Proactively develop, lead and drive the execution of Quality strategy and oversight for BioTissue.
- Lead the development, management and continual improvement of the Quality Management System (QMS).
- Establish and maintain the quality system, developing quality policies and objectives.
- Lead external and internal audits, complying with various regulatory requirements.
- Serve as a key leader at BioTissue, ensuring QA/QC objectives are met.
- Mentor the Quality organization, ensuring appropriate levels of accountability.
- Responsible for the Quality Control function as it pertains to Environmental Monitoring and Quality Assurance activities.
- Responsible for strategic leadership of the company’s Quality Management System (QMS).
- Facilitate management review of QMS to monitor performance.
- Support personnel with MDR/HHE reporting as well as the Change Control and CAPA processes.
- Set and maintain regulatory policies and quality standards for all quality systems.
- Drive execution of QMS processes through programs, policies and functions that support corporate and product quality.
- Collaborate cross-functionally with internal departments on strategy development and implementation of quality principles.
Requirements
What you’ll need- Bachelor’s degree in a related field, required
- Master’s degree in a related field, preferred
- Certified Quality Auditor (CQA), preferred.
- 15 years’ minimum experience in quality within the biotech, medical device and pharmaceutical industry, preferred.
- Proven track record of leading Quality programs and related activities in large organizations.
- Strategic thinker and strong interpersonal skills suited for communicating and effectively working with C-suite executives.
- Good advisory skills.
- Highly motivated, excellent written and verbal communication skills, strong analytical and leadership skills.
- Work under pressure and excellent organizational management skills.
- Position requires high integrity and ethics.
- Ability to develop and present regulatory and quality data and strategies.
- Skilled in budget preparation and fiscal management.
- Advanced knowledge and understanding of medical principles, methods, and procedures.
- Excellent mentorship, and people management skills and the ability to manage projects and achieve results through others.
- Working knowledge of conflict resolution and mediation principles and techniques.
Benefits
Comp & perks- Sedentary work that generally requires sitting and/or standing
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality Management System (QMS)Environmental MonitoringQuality AssuranceMDR/HHE reportingChange ControlCAPA processesBudget preparationFiscal managementRegulatory data presentationQuality policies development
Soft Skills
Strategic thinkingInterpersonal skillsAdvisory skillsWritten communicationVerbal communicationAnalytical skillsLeadership skillsOrganizational managementMentorshipConflict resolution
Certifications
Bachelor’s degreeMaster’s degreeCertified Quality Auditor (CQA)
