Corporate Vice President, Global Quality Assurance

2 weeks ago

Newark DE United States Hologic Full time

Vice President, Global Quality Assurance 

Hybrid working model from one of our locations including Marlborough, MA, Newark, DE, San Diego, CA or Alajuela, Costa Rica

Hologic is seeking a highly experienced and strategic Global Vice President of Quality Assurance to lead our Quality Assurance (QA) teams across the globe. The ideal candidate will be responsible for ensuring that all Hologic products and services meet the highest quality standards and comply with all regulatory requirements. As a key leader within the organization, you will drive quality initiatives and foster a culture of continuous improvement.

What You Can Expect:

Overall responsibility for the development and implementation of the vision and strategy as well as budgets for the enterprise quality function. In partnership with regulatory affairs, support proactive relationships with the top management of the FDA and other leading regulatory authorities around the world to build and sustain an outstanding ongoing association.  Create and build confidence by establishing the quality assurance functions as an informed, capable, knowledgeable and accessible resource to staff, management and stakeholders, positioning the company as a preferred source for quality expertise. Maintain knowledge of the quality and regulatory environment and establish QA to be subject matter experts and collaborative partners. Ensure organization is expert on products and understand the ramifications of any changes to development programs and manufacturing processes. Lead and mentor a diverse QA team to enhance performance and ensure alignment with industry best practices. Ensures quality system compliance with requirements of FDA quality systems, ISO 9001 and EN46001 including maintaining FDA registration and Medical Device Listing for all products. Establish and manage an internal program for quality and regulatory inspections and audits. Manage a complaint handling system to ensure issues are addressed in a timely fashion and corrective actions are implemented promptly. Partner cross-functionally with Commercial, Operations, Service, Regulatory Affairs, etc. to support the overall business objectives of Hologic.

What We Expect: 

BS/BA degree or equivalent and extensive senior leadership experience within the quality function at a publicly traded company. Substantial experience in leading people and cross-functional initiatives with global exposure. Superior leadership skills with demonstrated ability to attract, retain and develop talent; inspirational leader who builds high-performing, cross-functional teams. Outstanding communication, negotiating, listening and customer service skills with a focus on satisfying customer (both internal and external) needs. Experience building quality systems that allow for consistent handling of customer complaints and corrective actions. Known as an expert in quality and compliance issues facing medical device and diagnostics companies with the ability to translate development strategies into actions. Possesses executive presence and experience with regulatory bodies. Capable of establishing immediate credibility with business partners as well as within/outside the company, able to build consensus and achieve goals through influence versus direct line authority

What We Offer

Innovative and Impactful Work: Contribute to a company at the forefront of women's health, with cutting-edge medical technology that makes a significant difference in patients' lives worldwide. Growth and Development: Join a rapidly expanding company with opportunities for professional growth, personal development, and career advancement within global locations. Diverse and Inclusive Culture: Become part of a diverse workforce in an inclusive environment that values the unique backgrounds, experiences, and perspectives of all employees. People-Centered Approach: Engage with a company that prioritizes the well-being and development of its people, reflected in its people-centred culture and supportive management. Competitive Compensation: Enjoy competitive salaries and comprehensive compensation packages that reward dedication and excellence. Health and Wellness: Benefit from a robust benefits package which is highly competitive in the markets where we operate.

If you are a visionary leader passionate about quality and looking to make a global impact in the healthcare industry, we want to hear from you. 

Hologic is an equal opportunity employer committed to promoting diversity and inclusion within our workforce. We encourage all qualified candidates, regardless of gender, race, disability, religion, or sexual orientation, to apply.

We look forward to welcoming you to the Hologic family

#LI-JD1 

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