Director, Commissioning, Qualification, and Validation

Kymanox•Morrisville, NC

About The Position

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. Responsibilities: The Director of Commissioning, Qualification, and Validation (CQV) is a strategic leader responsible for guiding both technical and managerial aspects of CQV/CSV projects while driving business development initiatives. This role manages a team of senior and junior resources through direct and indirect reporting structures, focusing on project execution and building and nurturing client relationships to promote Kymanox’s services. The position involves high-level strategic planning, team & project management, hands-on execution of projects, and enhancing Kymanox's market presence. The ideal candidate will be an industry expert (SME) in CQV, utilizing their extensive experience and professional network to identify new business opportunities and strengthen client engagement. The Director of CQV is primarily responsible for: Technical Leadership: Deliver senior technical oversight to client-facing Kymanox project teams, ensuring accountability for project strategy, execution, and overall client satisfaction. Project Oversight: Oversee the planning and implementation of CQV/CSV activities, delegating tasks while monitoring quality and progress, and providing necessary technical direction to project teams. Client Relationship Management: Establish and cultivate strong relationships with clients, understanding their needs and expectations to deliver tailored CQV/CSV solutions. Proactively engage with prospective clients to identify new business opportunities and foster partnerships. Business Development Leadership: Drive business growth by leveraging an extensive professional network within the pharmaceutical, biotech, and medical device sectors. Collaborate closely with Kymanox's Business Development and Marketing teams to develop strategic approaches for promoting CQV/CSV services and pursuing new market opportunities. Marketing and Networking Engagement: Actively participate in industry conferences, seminars, and/or public speaking engagements to represent Kymanox and enhance its visibility, positioning the company as a thought leader in the CQV space. Mentorship and Development: Foster mentorship and growth within the team, providing development opportunities through cross-functional projects and direct partnerships. Functional Management: Lead and manage team performance through regular evaluations, coaching, resource allocation, goal setting, and monitoring time tracking and reporting. Process Improvement Initiatives: Support internal initiatives aimed at enhancing Kymanox processes and practices, assessing future business needs and implementing strategies to meet those needs effectively. Compliance Assurance: Ensure conformance with both Kymanox and external regulatory standards, conducting rigorous technical and quality reviews of all source documents. Documentation Management: Author and/or review process documentation including user requirements, technical design specifications, risk management documents (including user FMEA), and verification and validation testing protocols, while identifying any regulatory risks during reviews. Subject Matter Expertise: Provide expert knowledge across all CQV and CSV disciplines. Travel: Ability to travel up to 25% during active client engagements as required.

Requirements

Bachelor's and/or Master’s degree in a science-related field (e.g., Biomedical Engineering, Mechanical Engineering, Chemical Engineering).
A minimum of 15 years of experience in pharmaceutical, vaccine, biotech/biologics, cell/gene therapy, and/or medical device sectors.
At least 10 years in a leadership capacity, demonstrating an established track record of guiding high-performing teams.
Direct experience executing CQV activities for facilities, utilities, equipment, and processes.
Strong working knowledge of cGMP (21 CFR 210/211, Part 11, EU Annex 1, EU Annex 11), ASTM E2500, GAMP 5, and ISPE guidelines.

Nice To Haves

Experience with automated equipment (formulation, filling lines, isolators, device assembly equipment, finish/packaging, clean utilities, etc.) strongly preferred.
Direct experience or in-depth knowledge of CSV activities for computerized systems supporting manufacturing operations (ERP, CMMS, QMS, BMS, EMS, etc.)
Familiarity with pre-filled syringes, autoinjectors, co-packaged kits, and other drug delivery systems is preferred.

Responsibilities

Deliver senior technical oversight to client-facing Kymanox project teams, ensuring accountability for project strategy, execution, and overall client satisfaction.
Oversee the planning and implementation of CQV/CSV activities, delegating tasks while monitoring quality and progress, and providing necessary technical direction to project teams.
Establish and cultivate strong relationships with clients, understanding their needs and expectations to deliver tailored CQV/CSV solutions. Proactively engage with prospective clients to identify new business opportunities and foster partnerships.
Drive business growth by leveraging an extensive professional network within the pharmaceutical, biotech, and medical device sectors. Collaborate closely with Kymanox's Business Development and Marketing teams to develop strategic approaches for promoting CQV/CSV services and pursuing new market opportunities.
Actively participate in industry conferences, seminars, and/or public speaking engagements to represent Kymanox and enhance its visibility, positioning the company as a thought leader in the CQV space.
Foster mentorship and growth within the team, providing development opportunities through cross-functional projects and direct partnerships.
Lead and manage team performance through regular evaluations, coaching, resource allocation, goal setting, and monitoring time tracking and reporting.
Support internal initiatives aimed at enhancing Kymanox processes and practices, assessing future business needs and implementing strategies to meet those needs effectively.
Ensure conformance with both Kymanox and external regulatory standards, conducting rigorous technical and quality reviews of all source documents.
Author and/or review process documentation including user requirements, technical design specifications, risk management documents (including user FMEA), and verification and validation testing protocols, while identifying any regulatory risks during reviews.
Provide expert knowledge across all CQV and CSV disciplines.
Ability to travel up to 25% during active client engagements as required.