Senior Director, Quality

Senior Director, Quality

The Senior Director, Quality serves as the Management Representative for the Company who oversees and ensures the effectiveness of the Quality Management System (QMS). The Senior Director ensures Quality Policies and QMS processes are documented; ensures quality system and applicable regulatory requirements are effectively established and maintained; promotes awareness of the QMS and regulatory requirements throughout the organization; and reports to Management on the performance and effectiveness of the QMS and any need for improvement. The Senior Director champions continuous improvement of the QMS. The Senior Director manages Quality department personnel in the daily QMS operation and oversees timely accomplishment of Quality Objectives, departmental goals, and business initiatives.

The Senior Director, Quality reports to the VP, Regulatory.

Qualifications/Requirements:

· Bachelor's degree in Science, Engineering, Life Sciences, or related discipline

· 10+ years of experience in a regulated medical device, pharmaceutical or life sciences company with specific experience in ensuring compliance to FDA and international regulatory requirements

· 5+ years of experience in personnel management

· Expert knowledge of FDA and International quality management system (QMS) and Good Manufacturing Practice (GMP) regulations and standards (e.g., 21 CFR 820, ISO 13485, ISO 14971, and European Union Medical Device Regulation (MDR) 2017/745)

· Practical application experience in continuous improvement methodologies to improve processes, strengthen quality, and drive efficiency

· Strong analytical ability including the ability to effectively use quality data in problem solving and to evaluate process changes and impacts

· Experience with all phases of product development and manufacturing lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization

· High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction

· ASQ certification (e.g., CMQ/OE, CSQP, CQE, CQA) and/or Six Sigma certification preferred (not required)

· Excellent communication skills: Written, verbal and interpersonal

Job Description:

· Provides direction to Quality department in daily operations and timely completion of departmental and organizational goals

· Develops, implements and manages a documented and effective QMS in accordance with 21 CFR 820, ISO 13485:2016, MDSAP requirements and other global regulatory requirements

· Promotes awareness of QMS and applicable regulatory requirements throughout the organization

· Documents QMS planning including defining quality policies, objectives, and performance in conjunction with Management with Executive Responsibility

· Serves as the Management Representative in accordance with 21 CFR 820 and ISO 13485:2016

· Reports to Management with Executive Responsibility (top management) on the performance and effectiveness of the QMS and any need for improvement

· Oversees QMS processes for control of quality system documents and records (including document control; record control and retention; labeling and packaging control; advertising and promotional materials; and validation of computer systems used for electronic records and/or in the QMS)

· Oversees QMS processes for resource management and product realization (including design controls; purchasing controls; supplier management; product identification and traceability; production and process controls; and handling, storage, and distribution of product)

· Oversees processes for monitoring, measuring, analysis, and improvement to demonstrate conformity of the product, ensure conformity of the QMS, and maintain the effectiveness of the QMS (including feedback on customer requirements, production and post-production activities; complaint handling; advisory notice and reporting to regulatory authorities; internal quality audits; product acceptance activities (e.g., lot record review); control of nonconforming product; analysis of quality data; and corrective and preventive action (CAPA))

· Oversees the Management Review process, including preparing inputs based on analysis of quality data, leading meetings, recording outputs, and addressing applicable decisions and actions

· Oversees the training process for all personnel (including consultants, contractors and contract sales representatives) on QMS and GMP elements

· Provides Quality support and expertise for engineering and manufacturing activities (e.g., design development, risk management, qualification, verification, validation, purchasing, and production controls) to ensure all quality system and regulatory requirements have been met and are adequately documented

· Oversees Quality review of promotional materials, product labeling, design control documentation, risk management, and quality system documentation

· Determines lot hold/quarantine and recall decisions in conjunction with Management with Executive Responsibility (top management)

· Serves as the Quality company contact to regulatory bodies (FDA and notified bodies)

· Leads and oversees external regulatory, customer, third-party, and internal audits or inspections

· Identifies potential areas of compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues; and provides general guidance on how to avoid or manage similar situations in the future

· Directs initiatives that accomplish continuous improvement and cost effectiveness and enhance efficiencies and compliance of processes and procedures