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Senior Vice President of Quality Assurance

2 months ago

Andover, Massachusetts, United States embecta Full time

Position Overview

The Senior Vice President of Quality Assurance plays a crucial role in steering the Quality division within embecta, a leading global diabetes care organization. This individual will report directly to the Chief Technology Officer (CTO) and will be instrumental in cultivating a robust culture of quality and adherence to international standards.

Key Responsibilities:

  • Strategic Leadership: Direct and oversee the Quality division, promoting a customer-centric ethos.
  • Cross-Functional Collaboration: Work closely with various departmental leaders to meet business goals and enhance quality initiatives.
  • Quality and Compliance Planning: Formulate and execute the Quality and Compliance strategy to support engineering, manufacturing, and supplier operations.
  • Process Optimization: Advance quality management frameworks and practices to ensure operational efficiency.
  • Continuous Improvement: Identify and spearhead initiatives for ongoing enhancement in partnership with Operations, Supply Chain, Marketing, and R&D.
  • Talent Development: Create and implement a three-year plan to strengthen the quality management team, focusing on diversity, inclusion, and succession planning.
  • Regulatory Compliance: Establish and uphold quality standards in line with regulatory requirements.
  • Management Review Oversight: Ensure effective communication and transparency of quality systems through the Management Review Process.
  • CAPA System Implementation: Lead the deployment of a Corrective and Preventative Action system, ensuring compliance with both US and international regulations.
  • Mergers and Acquisitions: Conduct thorough assessments for potential acquisitions, providing expertise and evaluating supplier capabilities.

Qualifications:

  • Over 10 years of experience in Quality Management and Compliance, ideally within Manufacturing or Operations.
  • Extensive experience with Class II and Class III medical devices.
  • At least 7 years in middle to senior management roles.
  • A Bachelor's degree is preferred; a Master's degree in a relevant scientific or engineering discipline is advantageous.
  • In-depth knowledge of FDA and international medical device regulations.
  • Demonstrated financial management capabilities and organizational insight.
  • Exceptional communication, analytical, and problem-solving abilities.
  • Proven ability to influence, negotiate, and nurture talent within a matrixed organization.
  • High standards of performance, accountability, and self-motivation.
  • Effective communication skills, both verbal and written, with stakeholders.
  • A collaborative approach to achieving compliant outcomes.

embecta is committed to fostering an inclusive workplace and is an Equal Opportunity/Affirmative Action Employer.