Sr. Director, Regulatory Compliance

Medline Industries, LP • Mundelein, IL

2d • $203,000 - $305,000

About The Position

Responsible for overseeing and directing strategic planning for large and highly complex Regulatory –Quality- Laboratory teams; ensuring quality and compliance for applicable products, processes, and services for assigned departments. Oversee management of regulatory compliance areas that include the global regulatory/quality audit process, ethical sourcing audit process, validations, quality clinical-affairs, Quality Management Systems, and handle all staffing-related activities for these groups. Oversee management of Medline Laboratories areas including Chemistry technical development and testing teams, Microbiological technical development and testing teams, Calibrations, Lab Software Management, GLP Quality Assurance, Laboratory Operations and handle all staffing-related activities for these groups. Job Description Responsibilities: Management all of the global regulatory/quality audit process, ethical sourcing audit process, validations, quality clinical-affairs, Quality Management Systems, Risk Management process and employees. Ensure that the program remains compliant with FDA regulations, global regulations, and ISO standards. Management all of the Chemistry technical development and testing teams, Microbiological technical development and testing teams, Calibrations, Lab Software Management, GLP Quality Assurance, Laboratory Operations, and employees. Ensure that the program remains compliant with FDA/global regulations, GLP requirements, and ISO standards. Provide leadership and expertise in the development of strategy for the applicable organizations; motivate and engage others around team vision and manage others to ensure execution. Manage Laboratory business. Provide assistance, support and expertise to Suppliers, manufacturing partners and Medline in developing and implementing QA systems and Laboratory Operations. Lead FDA/ global regulatory inspections at Medline and throughout the company Supply Chain as needed. Oversee and delegate technical projects such as design control remediation, validation efforts and other projects as assigned by the VP of Reg Affairs & R&D. Act as a senior member in acquisition quality/regulatory due diligence assessments as assigned by the VP of Reg Affairs & R&D. Lead the development, integration and the continuous improvement of Medline Quality Systems globally and R&D Laboratory. Lead Post-Market Clinical MDR evaluations and risk management activities. Responsible for day-to-day management and oversight of the laboratory business to include sourcing, customer contracting, operations, pricing, finance, and competitive strategy. Analyze global growth opportunities by technical area and testing capability; identify and prioritize laboratory focus to achieve margin targets based on acquired insights. Drive the strategic development and launch of new services and programs. Develop revenue, cost of services, and expense forecasts; ensure that all forecasts are supported with appropriate execution / staffing plans. In an effort to achieve continued long-term growth, evaluate strategic opportunities to: a) to better serve, internal and external customers b) build strategic partnerships upstream and/or downstream c) invest capital into high ROI initiatives. Interface with Executive Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, laboratory resources, regulatory compliance, and supplier controls are met. Management responsibilities include: Typically, manage through multiple Managers. Provide leadership and management to one or more major departments of an operating unit or to a department that has system-wide accountability. Strategic, tactical and operational planning (12 + months) for the function or department; Direct budgetary responsibility for one or more departments, functions or major projects/programs; Interpret and execute policies for departments/projects and develops; Recommend and implement new policies or modifications to existing policies; Assess and advise resource and infrastructure needs; Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

Requirements

• Bachelor’s degree in Engineering, Science, or Technical Field.
• At least 8 years of experience working with QSR/GMP/ISO.
• At least 5 years of management experience.
• Experience analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
• Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.
• Experience controlling and coordinating high-risk regulatory interactions and acquisitions projects.
• Position requires travel up to 30% of the time for business purposes (within state, out of state and/or internationally).

Nice To Haves

• Experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries.

Responsibilities

• Management all of the global regulatory/quality audit process, ethical sourcing audit process, validations, quality clinical-affairs, Quality Management Systems, Risk Management process and employees.
• Ensure that the program remains compliant with FDA regulations, global regulations, and ISO standards.
• Management all of the Chemistry technical development and testing teams, Microbiological technical development and testing teams, Calibrations, Lab Software Management, GLP Quality Assurance, Laboratory Operations, and employees.
• Ensure that the program remains compliant with FDA/global regulations, GLP requirements, and ISO standards.
• Provide leadership and expertise in the development of strategy for the applicable organizations; motivate and engage others around team vision and manage others to ensure execution.
• Manage Laboratory business.
• Provide assistance, support and expertise to Suppliers, manufacturing partners and Medline in developing and implementing QA systems and Laboratory Operations.
• Lead FDA/ global regulatory inspections at Medline and throughout the company Supply Chain as needed.
• Oversee and delegate technical projects such as design control remediation, validation efforts and other projects as assigned by the VP of Reg Affairs & R&D.
• Act as a senior member in acquisition quality/regulatory due diligence assessments as assigned by the VP of Reg Affairs & R&D.
• Lead the development, integration and the continuous improvement of Medline Quality Systems globally and R&D Laboratory.
• Lead Post-Market Clinical MDR evaluations and risk management activities.
• Responsible for day-to-day management and oversight of the laboratory business to include sourcing, customer contracting, operations, pricing, finance, and competitive strategy.
• Analyze global growth opportunities by technical area and testing capability; identify and prioritize laboratory focus to achieve margin targets based on acquired insights.
• Drive the strategic development and launch of new services and programs.
• Develop revenue, cost of services, and expense forecasts; ensure that all forecasts are supported with appropriate execution / staffing plans.
• Interface with Executive Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, laboratory resources, regulatory compliance, and supplier controls are met.
• Strategic, tactical and operational planning (12 + months) for the function or department
• Direct budgetary responsibility for one or more departments, functions or major projects/programs
• Interpret and execute policies for departments/projects and develops
• Recommend and implement new policies or modifications to existing policies
• Assess and advise resource and infrastructure needs
• Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.

Benefits

• Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees