Description
Position at Kymanox
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., IND/NDA/BLA/IDE/510(k)/PMA).
- Working knowledge of Quality System requirements (FDA 21 CFR Part 820, Parts 210/211, Part 4, ISO 13485, and ISO 9001).
- Working knowledge of ICH guidelines for CTD, GMPs, clinical, human factors, nonclinical and pharmaceutical quality requirements.
- Working knowledge of design controls (FDA 21 CFR 820.30).
- Working knowledge of device risk management (ISO 14971) and drug risk management (ICH Q9).
- Working knowledge of EU medical device and medicinal product regulations.
Desired Aptitude and Skill Set:
- Detail-oriented
- Strong organizational skills and verbal/written communication skills
- Highly motivated self-starter with a sense of ownership and willingness to learn
- Thrive in a fast-paced, growing, and dynamic work environment
- Ability to form partnerships with internal and external stakeholders
- Seasoned soft skills (i.e., high EQ)
- Technology savvy
Travel:
Up to 20% travel is possible for audit support. A passport is required for this job.
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 90 days 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, and we have offices in Boston, Chicago, Philadelphia, and New Jersey.
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.
