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Kymanox · 1 day ago

Director, Commissioning, Qualification, and Validation

Morrisville, North Carolina

Full-time

Onsite

Director/Executive

15+ years exp

Kymanox is a life sciences professional services company dedicated to delivering high-quality solutions in the life sciences industry. The Director of Commissioning, Qualification, and Validation (CQV) is responsible for guiding technical and managerial aspects of CQV projects, managing a team, and driving business development initiatives to enhance Kymanox's market presence.

Life ScienceTechnical Support

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

Qualification

CQV expertiseCGMP knowledgeLeadership experienceBusiness developmentClient relationship managementProcess improvementDocumentation managementTechnical oversightNetworking engagementMentorship

Required

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

Direct experience or in-depth knowledge of CSV activities for computerized systems supporting manufacturing operations (ERP, CMMS, QMS, BMS, EMS, etc.)

Strong working knowledge of cGMP (21 CFR 210/211, Part 11, EU Annex 1, EU Annex 11), ASTM E2500, GAMP 5, and ISPE guidelines

Ability to travel up to 25% during active client engagements as required

Preferred

Experience with automated equipment (formulation, filling lines, isolators, device assembly equipment, finish/packaging, clean utilities, etc.) strongly preferred

Familiarity with pre-filled syringes, autoinjectors, co-packaged kits, and other drug delivery systems is preferred