Manager, Quality & Compliance

Responsibilities

• Assist with internal and external audit management for internal, supplier and vendor assessments, and help maintain standard audit process and documentation including remediation oversight as needed.
• Collaborate with the OneHUB team on oversight of all monitoring activities for functional areas of responsibility.
• Assist with remediation plans for control weaknesses or gaps identified.
• Responsible for proactively identifying potential noncompliance before occurrence.
• Develop and monitor appropriate quality metrics for review by management including inputs into the management review process.
• Assist in the influence of key patient service business leads to implement quality & compliance programs and controls as the OneHUB Q&C SME.
• Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Support a continuous improvement culture that results in simplification and gained efficiencies throughout the business.
• Work to integrate the quality system into all that we do, including project management, metrics, and performance review process.
• Build cross-functional relationships to ensure end to end quality and manage risk.
• Increase awareness and knowledge within the business on quality standards and expectations.

Qualifications

• Position requires BS degree in a science related area.
• Master's degree and work experience in the pharmaceutical industry preferred.
• 5+ years of compliance or Quality Systems experience with some leadership experience and a demonstrated understanding of relevant regulations and standard operating procedures.
• This role requires the candidate to be physically located in Lake County, Illinois and adhere to 3-day in office ways of working.
• Strong organizational, strategic thinking, analytical and reporting skills, and strong understanding of the patient services and pharmaceutical business.
• In-depth understanding of the pharmaceutical patient centricity, customer service oriented, and quality systems.
• Human relations and administrative skills necessary to establish and maintain effective working relationships with team members, co-leaders, and senior leadership.
• Sound judgment in evaluating and establishing compliance strategic plans as well as in day-to-day situations.
• Conflict resolution skills including persuasive management techniques required.
• Excellent data creation, storytelling, power point and analytics skills.
• Excellent verbal, written, presentation and interpersonal skills required.
• Ability to communicate concepts and problems in terms that are understandable to all levels of the organization, including senior leadership.
• Must be willing to travel up to 10-15% domestically.