Commissioning, Qualification, & Validation Associate Director

Flexible - Depending Upon Candidate  /  Commissioning & Qualification  /  Full Time


About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 600 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
CAI agents will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
 
Position Description
The CQV Associate Director, also known as a Discipline Lead (DL) is a recognized CQV subject matter expert, who can act in a project oversight role, to include managing client relationships for particular projects or at a site, and can do that for multiple sites simultaneously. Engages in strategic project work designed to be a door-opener for larger teams once the initial expert engagement is over, or as part of a larger project to deliver special expertise. Works for and reports to the CQV business area leader.  Has a special metrics-based bonus plan.  Supports the client project team. The person would also be available as an internal source of knowledge in support of proposals, our Tier III qualification program, or in response to the needs of our teams across the globe for such expertise remotely.
 
Can provide consulting to clients for best-in-class CQV methods to include:
1.     Integrated commissioning and qualification using a risk-based approach
2.     Quality risk management (QRM) implementation methods
3.     CQV program assessment and associated optimization
4.     Supplier assessment and audit
5.     CQV methods for a broad range of life science equipment, facility, and utility
6.     Equipment and automation interface and integration
7.     Project schedule acceleration with a focus on project delivery and product speed to market
 
You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
As the Associate Director for CQV at CAI, you are a subject matter expert who: 
1. Is engaged in industry forums, speaking, writing articles, participating in society committees, supporting standards or guidance document creation within such groups, and has a network of industry contacts who would recognize you as being an expert in CQV. 
2.    Can provide consulting to clients in best in class CQV.
3.    Can act in a project oversight role, to include managing client relationships for particular projects or at a site and can do that for multiple sites simultaneously.
4.    Researches organizations and individuals to find new opportunities.
5.    Engages in strategic project work designed to be a door-opener for larger teams once the initial expert engagement is over, or as part of a larger project to deliver special expertise.
6.    Mentoring employees and creating internal qualification and training content.
7.    Drafting and reviewing professional, high-quality, and consistent CQV estimates and proposals.
8.    Increasing the value of current customers while attracting new ones.
Additionally, you will support billable projects as a CQV consultant with emphasis on project initiation and support.   You may be assigned to manage internal programs with cross-functional teams comprised of client employees and/or contractors.
 
Position Requirements:
BS or MS in a relevant science or engineering field, or equivalent
Ten (10) or more years in CQV SME roles for life sciences.  Demonstrated success in leading your team to achieve defined goals. 
Excellent oral and written communication skills in English
Excellent skill in leading teams to perform complex tasks under pressure
Excellent problem-solving skills
Customer-service focused
Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.

APPLY FOR THIS JOBALL OPEN POSITIONS

CAI BENEFITS

(Varies by Country, Below is a General Overview)

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
  • Other Benefits Depending on Country