At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 50+ facilities across the US and 18,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers—and their patients—are at the heart of what we do.
Our mission is to empower our customers to advance healthcare, and our success starts with our teammates.
Owens & Minor teammate benefits include:
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, ensuring effective governance, assurance, and improvement of the processes required to comply with the complex array of regulations that govern Owens & Minor operations. 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 inclusive of product development, manufacturing, sourcing, distribution and value-added services. The VP drives continuous improvement and adaptation of QARA processes to support customers in a growing and expanding business environment. The VP is responsible for building a culture of awareness, accountability and consistency across the company’s current and future business lines related to the safety and efficacy of the medical device, pharmaceutical, and food products that Owens & Minor manufactures and/or distributes.
The VP Global QARA works closely with other business and functional leaders in driving high quality global processes suited to the range of Owens & Minor business operations while maintaining a separation of duties and accountabilities between these functions. The VP reports directly to the EVP/CEO, Products & Healthcare Services, who in turn reports to the CEO, and ensures that functional performance meets the guidelines for compliance with global regulations and standards (including ISO-13485 & FDA requirements).
The VP brings a high business acumen and “commercial” mindset to the business to help drive growth by establishing an effective and efficient quality management system that is a strategic agent for growth. The VP is accountable for extending the QMS to suppliers and customers to ensure that high quality is a competitive advantage in expanding the company’s business and retaining customers.
In addition, the Vice President of Quality Assurance & Regulatory Affairs will also:
Establish a strong “tone-from-the-top” of high-quality processes that comply with international regulatory requirements. Demonstrate the benefit to the business, customers and shareholders of rigorous, continuously improving quality and regulatory processes.
Lead and oversee a world-class quality assurance program that performs quality reviews and approval of documents, data, protocols, qualifications and change controls. Identify deviations and launch necessary investigations with CAPA activities and support with quality audits and process inspections.
Lead and build out a robust regulatory affairs team and processes that are proactive in ensuring the business is compliant with global standards and compliance requirements and can effectively operate as the “point-of-the-spear” in communication with global regulatory authorities.
Collaborate with the General Counsel and legal team to establish guidelines for and coordinate interactions with regulatory authorities. Guide, instruct and coach team in compliance issues, leading reviews and training sessions when/if necessary.
Develop KPIs, processes and SOPs to support our operations as well as our clients with thousands of SKUs and distribution points. Work with the operations team and quality leaders at suppliers and customers to align O&M’s business lines and to support growth of core and new product lines.
Assess technology and build business cases for necessary updates, improvements and major investments needed to prevent inefficiencies, inaccuracies and inconsistencies.
Mentor, lead and develop a team to create a culture that is forward-thinking, pro-active, responsive and preventative.
Education and Experience:
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.
Knowledge, Skills & Abilities:
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.
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If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.
Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.
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