Senior Quality Manager - Inspection Readiness & Response Management

Job Summary

Responsible for leading the quality and compliance for applicable products and processes for assigned department(s). Set organizational priorities, oversee resource utilization and develop operational plans and policies.

• Monitor and maintain compliance with applicable (ex. QSR, GMP, ISO) pertaining to the applicable life cycle and regions of distribution for the product.
• Act as liaison with the Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, on time delivery, and customer satisfaction.
• Devise and implement effective communication strategies with Divisions, Suppliers, Manufacturing, and/or Operations Executives and other internal and external Stakeholders.
• Leads the process and team during investigations and identifying resolutions for issues relating to product or production quality by interfacing with Divisions, Suppliers, Manufacturing, and/or Operations.
• Devise and implement continuous improvement initiatives, develop and share best practices, and particpate in policy setting activities.
• Oversee the execution to the resolution of all quality issues.
• Provides Leadership support during internal/external regulatory audits.
• Develop and maintain the enterprise inspection readiness program to ensure continuous compliance with FDA, EMA, ISO, and other applicable regulatory requirements.
• Lead regulatory inspection preparation activities, including mock inspections, readiness assessments, risk evaluations, and coaching of key personnel.
• Direct inspection response activities, including front-room and back-room operations, document management, response coordination, and executive communications.
• Partner with Quality, Manufacturing, Regulatory Affairs, and Operations leaders to identify compliance risks and strengthen quality system effectiveness.
• Lead post-inspection activities, including observation responses, remediation programs, CAPA execution, and effectiveness verification.
• Monitor regulatory trends and industry best practices to continuously improve organizational inspection readiness and compliance maturity.
• Management responsibilities include:
• --Typically, manages through multiple Managers and/or Supervisors
• --Oversee major projects/programs/outcomes;
• --Budget responsibility;
• --Interpret and execute policies for departments/projects and develops;
• --Recommend and implement new policies or modifications to existing policies;
• --Provide general guidelines and parameters for staff functioning;
• --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.

• Typically requires a Bachelor’s degree in Engineering, Science, or Technical Field. Equivalent level of experience also acceptable.

• None

• At least 5 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 2 years of management experience.

• Depth of technical knowledge of relevant standards and regulations (21
  
  CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR etc.)
• Proficiency in analyzing and reporting data and performing statistical analysis in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
• Demonstrated ability to control and coordinate concurrent projects, competing priorities and critical…