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Vice President of Quality Assurance (Woburn)
Vice President of Quality Assurance (Woburn)Confidential • Woburn, MA, US
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Vice President of Quality Assurance (Woburn)

Vice President of Quality Assurance (Woburn)

Confidential • Woburn, MA, US
[job_card.30_days_ago]
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  • [job_card.part_time]
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Vice President of Quality Assurance

About the Company

Innovative biotech company creating therapies to cure specific cancers

Industry

Medical Devices

Type

Public Company

Founded

1997

Employees

201-500

Business Classifications

  • B2B
  • SAAS
  • Enterprise

About the Role

The Company is seeking a Vice President, Quality Assurance to lead the global quality management system for its medical and pharmaceutical products. The successful candidate will be responsible for the development, maintenance, and practical application of the quality management system in compliance with all relevant regulations and standards. This role requires a minimum of a Bachelor's degree in a relevant field, with a preference for a post-graduate degree in regulatory affairs or a commercial discipline. A minimum of 10 years of industry experience in both multi-national pharmaceutical and medical technology environments is mandatory, with a proven track record in obtaining FDA approvals and leading successful CE submissions. The Vice President, Quality Assurance will also be expected to have extensive experience in people leadership, excellent communication skills, and the ability to work within cross-functional and multi-disciplinary teams.

Key responsibilities for the Vice President, Quality Assurance at the company include leading the global QA team, fostering a collaborative approach to key initiatives, and ensuring that all quality activities are conducted with the highest ethical standards. The role demands a leader who can maximize on-time product approvals, manage strict regulatory practices globally, and maintain high-quality relationships with regulatory bodies. The ideal candidate will be an expert in relevant regulatory requirements and will be committed to the company's values of advancement and quality. The position is pivotal in the company's mission to provide innovative healthcare solutions that enhance patient outcomes, and the role will be considered a hybrid position, with a minimum of 3 days in the office and 2 days remote work per week.

Hiring Manager Title

Senior Vice President, Quality and Regulatory Affairs

Travel Percent

15%

Functions

  • Operations
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