Owens & Minor · 1 day ago

VP, Global Quality Assurance & Regulatory Affairs

United States

Full-time

Remote

Director/Executive

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Health CareSupply Chain Management

Actively Hiring

Hiring Manager

Nick Acchione

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Responsibilities

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.

Qualification

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Global QARA experienceQuality management systemRegulatory complianceFDA requirementsISO-13485Lean certificationSix Sigma certificationContinuous improvement methodologyQuality auditsHealth care complianceMaster's degree

Required

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.

In depth knowledge and experience in global pre-market, post-market and quality system regulations.

Working knowledge of health care compliance and privacy.