Jobs and Careers

Senior Director, Quality

Morrisville, United Statesfull_timeVerifiedPosted 3 Jan 2025

About the role

Is Kymanox the right fit for you? You want to make a difference and have an impact… You enjoy having an influence in your day-to-day work… You are motivated by working alongside a team filled with subject matter experts who will help you learn and grow… You wake up every day and do what you do … because patients deserve better. If this sounds like you, you’ve come to the right place. The Senior Director, Quality will lead the quality organization at Kymanox. This role will be responsible for providing both technical and managerial leadership to senior, mid, and associate level resources through both direct and indirect reporting structure. This role will lead quality projects by providing extensive professional knowledge and experience in the biopharma, biotech and drug/device combination product space. This position involves providing quality oversight and serving as a Quality leader for product sponsors within their organizational structure, instituting phase-appropriate quality systems, and supporting Sponsors with navigating Pre-Approval Inspections (PAIs), quality system audits by FDA, EMA, and notified bodies, as well as successful compliance enforcement remediation. Kymanox also has an eQMS to support internal and external programs; this position includes accountability for that eQMS to ensure compliance and reinforce the strategic direction for the company. The role involves high-level strategic planning, business development support, as well as hands-on responsibilities. Responsibilities:

Provide senior technical leadership to external-facing Kymanox project teams with accountability for project strategy, execution, success, and client satisfaction.
Lead planning and execution of quality activities. Delegate and monitor quality and progress of work, providing technical support and direction to project teams.
Support the efforts of the Kymanox Business Development and Marketing teams as it relates to Quality, including presentations to prospective clients, public speaking engagements (i.e., conferences, industry events), and contributions to industry publications.
Provide mentorship and development opportunities to quality team, as part of cross-functional projects or as direct reports.
Functional management and leadership of direct reports within team.
Responsible for team performance reviews and evaluations, mentoring and coaching, resource management, goal setting, time tracking and reporting.
Identify risks and vulnerabilities, enforcing internal requirements and educating clients on boundaries of QMS and service offerings.
Support internal business initiatives to improve Kymanox processes and practices. Evaluates future business needs and derives/implements strategies to meet those needs.
Ensures conformance to Kymanox quality and external compliance standards.
Performs technical and quality review of source documents.
Leverage industry expertise and network to support and locate business related to professional services for Quality Management System (QMS) support, audits, compliance, remediation, and regulatory submissions.
Support quality team members with strategic direction to conduct audits/gap assessments of quality system documentation, regulatory submissions, design history files, risk management files, and technical documentation against industry regulations and standards (US/EU/ROW).
Responsible for providing sound quality and compliance expertise to help organizations with products in various stages of development become commercial ready, as well as overhauling/remediating entire quality systems.
Serve as company’s Management Representative.

Educational Background:

The ideal candidate will have a bachelor’s degree in engineering or science. Advanced Degree (e.g., Masters, PhD) preferred.

Experience:

15+ years’ compliance, operations, and quality experience in the US medical device, pharmaceutical, or combination products industries (this includes post graduate experience).
8+ years in a leadership role.
Certified Quality Auditor (CQA)
Demonstrated experience of preparing US FDA/EU EMA submissions (e.g.,