What are the responsibilities and job description for the Director, Commissioning, Qualification, and Validation position at Kymanox?
Job Description
I s 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
Bachelor's and/or Master’s degree in a science-related field (e.g., Biomedical Engineering, Mechanical Engineering, Chemical Engineering).
Experience
Up to 25% travel is possible.
Career Development
The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization.
Compensation
Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions. Eligible for incentive program after 6 months of outstanding work.
Benefits
Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.
About Kymanox
Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20 countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.
Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC.
To learn more about our company, please visit our website: Life Science Solutions | Kymanox
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry
I s 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.
Bachelor's and/or Master’s degree in a science-related field (e.g., Biomedical Engineering, Mechanical Engineering, Chemical Engineering).
Experience
- 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. 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.)
- Strong working knowledge of cGMP (21 CFR 210/211, Part 11, EU Annex 1, EU Annex 11), ASTM E2500, GAMP 5, and ISPE guidelines.
- Familiarity with pre-filled syringes, autoinjectors, co-packaged kits, and other drug delivery systems is preferred.
Up to 25% travel is possible.
Career Development
The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization.
Compensation
Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process – as well as market conditions. Eligible for incentive program after 6 months of outstanding work.
Benefits
Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.
About Kymanox
Join Kymanox – a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20 countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.
Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC.
To learn more about our company, please visit our website: Life Science Solutions | Kymanox
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry