113 applicants

Company

Confidential · 5 hours ago

VP, Quality and Regulatory Operations (QRO)

United States

Full-time

Remote

Director/Executive

10+ years exp

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Responsibilities

The Vice President Quality and Regulatory Operations will work collaboratively with colleagues across the company, and with outside partners, to design and execute company strategies.

Accountable for furthering the development and providing oversight of the quality systems and compliance strategies utilizing data and tools as well as the expertise of the team.

Oversee a robust Suspicious Order Monitoring (SOMS) validation process.

Assist the Compliance Department in developing and administering a supplier review program focused on supplier qualification, surveillance, and performance.

In conjunction with the Company’s Compliance department, oversee the design, develop, implement, and monitor quality and compliance activities and strategies in accordance with state and federal regulations governing these operations.

Analyzes data to identify process improvement opportunities.

Documents improvement action plans for processes and projects assigning the responsibilities to the various teams.

Works on Client Quality requirements to identify adequate process controls.

Partners with relevant stakeholders to deploy Quality Management System (QMS) infrastructure for Corrective and Preventive Actions (CAPAs), Deviations, Complaint Management, Change Controls.

Supports development and maintenance of Policies and Procedures.

Establishes Quality Assurance Plan for new projects.

Demonstrates and encourages the use of quality management theories, concepts and tools, and best practices into all work performed by self, direct reports, and agency staff as appropriate.

Design, implement, and track the success of compliance and quality management programs driven by statistics and analytics that ensure operations can meet high quality standards to its clients.

Communicate an overall vision for quality within the business units.

Set goals and recommend organizational changes to achieve goals.

Provide reports regularly, and as requested, to keep Executive Management informed of the operations and progress of compliance and quality efforts.

Lead a team of dedicated compliance and quality professionals to advance the mission of the organization.

The role will lead both managers & individual contributors across multiple lines of business within the functions of Quality Assurance, Supplier Quality, New Product Introduction, Materials & Product Validation & Training.

Directs functions at Business and Facility level, ranging from supply chain to pharmacy to wholesale distribution.

Qualification

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Quality Management System (QMS)Compliance strategiesSix Sigma/Lean certificationData analysisRegulatory compliance frameworksSupplier qualificationProject managementMicrosoft Office

Required

Degree in related field.

10+ years of experience in compliance and/or quality.

Strong influential leadership, coaching and feedback skills.

Ability to work in fast paced environment, with demonstrated ability to multi-task and resolve problems effectively and efficiently.

Well-developed oral and written communication skills including the ability to write and deliver both informal and formal presentations.

Ability to work in a highly matrixed environment.

Excellent logical, analytical reasoning, and problem-solving skills to evaluate business problems and apply knowledge to identify appropriate solutions; ability to resolve associate issues effectively and efficiently.

Strong project management acumen.

Excellent organizational, motivational, and interpersonal skills.

Proficient with Microsoft Office applications.

Aptitude for translating regulatory or quality requirements into business processes.

Dependable and ethical conduct.

Experience with strategic plans, business plans, headcount justification and budgets.