Senior Director of Quality Systems

Job Summary

Provides enterprise leadership for a central quality support organization that partners with multiple manufacturing locations to resolve complex quality and compliance issues, lead systematic remediation, CAPA execution, and strengthen manufacturing quality systems and processes.

This role is accountable for rapid, compliant problem resolution across sites while also driving longer-term capability building, standardization, and quality system maturity.

Manage people, projects, and priorities to address resource and operational challenges.

Direct and manage sites during FDA inspections and responses to observations.

Liaison with site operation management providing input and support to ensure Quality and Compliance requirements are being met. Partners cross-functionally with manufacturing, engineering, regulatory, operations, corporate quality, to increase regulatory compliance.

Support Quality Systems related activities, analyze problems related to quality/regulatory information, and provide process structure and technical support in solving these problems.

Provide expertise, counsel and guidance to Quality leadership.

Manage the Quality data integrity for Medline products including but not limited to, sterile products, medical devices, pharmaceuticals, biologics, cosmetics, medical foods, and dietary supplements.

Job Description

MAJOR RESPONSIBILITIES

• Lead personnel, activities, and resources for continuous Quality System improvement.  Motivate and engage the team and others around the operational excellence vision and ensure execution.
• Advises leadership to ensure the QMS for assigned departments are in compliance as measured by FDA/ISO/internal audits.
• Collaborate with cross-functional teams to deploy quality processes and systems. Consult and provide guidance to business partners.
• Partners with other applicable leaders to ensure a strategic approach to any regulatory audit and related responses.
• Partners with other applicable leaders to ensure a strategic approach to any regulatory audit and related responses Prepare and deliver Customer presentations
• Oversee critical Quality systems projects and team that identify, lead and drive opportunities to improve quality systems and develop long-term strategies that support the success of the business.
• Review and determine the application of various system compliance regulations. Ensure compliance to global regulatory requirements with internal procedures. Identify risk and compliance opportunities.
• Train and coach personnel and cross-functional teams to deliver optimal results.

Management responsibilities include:

• Typically manages through multiple Managers
• Provide leadership and management to one or more major departments of an operating unit or to a department that has systemwide 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; develop, recommend and implement new policies or modifications to existing policies
• 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

MINIMUM JOB REQUIREMENTS

Education

• Bachelor’s degree in technical or scientific discipline

Work Experience

• Knowledge of Food and Drug Administration (FDA), Quality System Regulations (QSR) and International Organization of Standardization (ISO).  Proficiency in Microsoft Suite. Position requires travel up to 20% of the time for business purposes (within state and out of state).

Knowledge / Skills / Abilities

MINIMUM JOB REQUIREMENTS

• 7 years experience in the Medical Device, Pharmaceutical industry, cosmetic, combination product industry
• 5 years experience leading people and cross functional teams through quality change and continuous improvement.
• Experience hosting FDA/ISO GMP inspections and regulatory meetings.
• Experience writing, reviewing, and managing FDA responses
• Experience with quality systems development and implementation.
• Experience with Medical Device Design Controls, CE technical File Requirements, and 510K submissions.
• Experience hosting FDA/ISO GMP inspections.
• Proficiency in analyzing and reporting data to identify issues, trends, or exceptions to drive improvement of results and find solutions.
• Demonstrated ability to contro