VP - Global Quality Assurance & Regulatory Affairs

2 days ago

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Owens & Minor

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Healthcare Distribution and Logistics • Healthcare • Healthcare Technology • Supply Chain

10,000+

💰 Post-IPO Debt on 2022-03

Description

• The VP Global QARA is a business partner who uses domain and industry-specific knowledge to foster buy-in and participation across business lines and functions. • The leader is a player-coach who is able to be hands-on while leading a global, multisite, cross-business function responsible for a world-class quality management system. • The VP drives continuous improvement and adaptation of QARA processes to support customers in a growing and expanding business environment. • The VP is accountable for extending the QMS to suppliers and customers to ensure that high quality is a competitive advantage. • Collaborate with the General Counsel and legal team to establish guidelines for and coordinate interactions with regulatory authorities.

Requirements

• Commensurate years of relevant global quality assurance & regulatory affairs experience with a strong history of operating in a global medical device/pharmaceutical manufacturing and distribution operation. • Direct expertise leading the transformation for a global multi-site operation in a larger or similar sized organization that is known for developing quality excellence & regulatory compliance initiatives. • Proven, successful leadership experience in a compliance-oriented company with extensive knowledge of legal and regulatory compliance issues related to global medical devices or pharmaceutical production and supply operations (including FDA & ISO-13485). • Demonstrated ability to function in an environment with a rich history that is going through a redirection in the business and culturally. • Excellent communication, interpersonal, and relationship skills at all levels within a global context and culture. • Strong leadership and innovation skills, and a mature judgment and a drive to meet business targets successfully. • A Master’s degree with special consideration given to advanced degrees. • Certification in lean, six sigma or equivalent continuous improvement methodology. • In depth knowledge and experience in global pre-market, post-market and quality system regulations. • Working knowledge of health care compliance and privacy.

Benefits

• Medical, dental, and vision insurance, available on first working day • 401(k), eligibility after 30 days of employment • Employee stock purchase plan • Tuition reimbursement • Development opportunities to grow your career with a global company