Sr. Manager Regulatory Compliance, Supplier Quality

Sr. Manager Regulatory Compliance, Supplier Quality

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Job Summary

Responsible for leading the quality and compliance for the Supplier Quality Program (Audits and Supplier Quality). Set organizational priorities, oversee resource utilization and develop operational plans and policies.

Responsibilities

• Monitor and maintain compliance with applicable regulations (e.g., QSR, GMP, ISO) pertaining to the applicable life cycle and regions of distribution for the product.
• Direct and manage complex, high-risk supplier audits and internal audits to evaluate Quality Management Systems (QMS) and regulatory compliance for manufacturers, contract sterilizers, laboratories, and raw material suppliers.
• Act as a senior liaison with Divisions, Suppliers, Manufacturing, and Operations leadership to ensure quality products, timely delivery, and customer satisfaction.
• Lead the process and team during investigations and identify resolutions for issues relating to the audit program by interfacing with Divisions, Suppliers, Manufacturing, and/or Operations.
• Devise and implement continuous improvement initiatives, develop best practices, and participate in policy-setting activities to enhance supplier quality globally.
• Oversee the execution of the audit plan and own all audit escalations.
• Create and oversee the supplier quality program and ensure all suppliers are held to appropriate rigor based on their risk.
• Provide leadership support during internal/external regulatory audits.
• Perform audits with teammates and individually.

Management Responsibilities

• Typically manages through multiple Managers and/or Supervisors.
• Oversee major projects/programs/outcomes.
• Budget responsibility.
• Ensure the team has adequate training and is state of the art.
• Interpret and execute policies for departments/projects and develop modifications.
• Recommend and implement new policies or modifications to existing policies.
• Provide general guidelines and parameters for staff functioning.
• Hire staff, recommend pay increases, perform performance reviews, training and development, estimate personnel needs, assign work, meet completion dates, and ensure consistent application of organizational policies.

Qualifications

• Typically requires a Bachelor’s degree in Engineering, Science, or Technical Field.
• At least 7 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21
  
  CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR).
• At least 3 years of management experience.

Preferred Qualifications

• At least 5 years of direct experience with recall management.

The Anticipated Salary Range For This Position

$ - $ Annual

Actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

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 a more comprehensive list of our benefits please . 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.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.