Executive Director, Quality & Compliance

Job Title: Executive Director, Quality & Compliance

Department: Quality & Compliance

Reporting To: President, Drug Manufacturing US

Classification: Exempt

Salary Range: 200k-240k/yr, Depending on Experience

What We Do

BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees.  Our US operations are US headquartered in Irvine, CA. Our 7 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.

Why BioDuro-Sundia?

Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.

Job Overview/Summary

The Executive Director, Quality & Compliance (ED) will establish and maintain a compliance program consistent with applicable regulatory requirements, standards, and established company policies and procedures. In addition, this role is intended to provide leadership and technical oversight to all functional quality control areas as well as contract services and CMOs that provide QC functions.

The ED is responsible for management of internal and external audits, regulatory inspections and related compliance activities. They will manage the associated assessment and remediation activities as a result of internal and external audits.

The ED shall establish and maintain programs to ensure the verification and monitoring of the effectiveness of the Quality System and its compliance to applicable regulations and standards and ensure relevant metrics are escalated as needed and/or routinely communicated to senior leadership through the Management Review process. They will establish Quality Objectives ensuring an effective monitoring and escalation process along with establishing programs to effectively monitor and assess the Quality System through representative metrics.  The ED shall assess the performance of the Quality System and ensure continuous improvement of such programs.

The ED shall support all activities where product is developed, manufactured, tested, dispositioned, and distributed. Further, they will proactively monitor the external environment to identify new or emerging regulations, determine the impact and create implementation strategies in alignment with BioDuro’s business goals.

Quality Systems: establish programs, guidelines, and procedures related to areas of responsibility to include but not limited to:

·         Management Review

·         CAPA

·         Non-Conformances

·         Quality Systems Review, Quality Objectives

·         Quality Metrics

·         Change Control Management

·         Data and Document Management

·         Records Management

·         Computer Systems Validation

·         Training Management

The ED, Quality and Compliance will establish and oversee the Quality Systems improvement strategy that includes responsibilities for development, implementation and the continuous improvement of the Quality System. They will partner with cross functional leaders across the company to drive standardization of the Quality Systems and compliance with established Policies and Procedures.

They are responsible for the development of Quality personnel in terms of leadership, training, and expansion of responsibilities.

Essential Functions and Responsibilities

• Manage all aspects of BioDuro’s Product Quality (Quality Systems, Quality Assurance, & Quality Control)
• Ensure the Total Quality Management system which includes establishment of high standards, as well as identification of and prioritizing improvement projects.
• Focus on standardization of methodologies across the company
• Provide direct and functional direction on policies from a quality perspective with client focus.
• Troubleshoot critical issues using quality tools to resolve root cause and cor