CQV Associate Director

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 Global Director.  Supports the client project teams. The person would also be available as an internal source of knowledge in support of proposals and our internal qualifications, or in response to the needs of our teams across the globe for such expertise remotely.

As the Associate Director for CQV at CAI, you are a subject matter expert who: 

·       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. 

·       Can provide consulting to clients in best-in-class CQV.

·       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.

·       Research organizations and individuals to find new opportunities.

·       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.

·       Mentoring employees and creating internal qualification and training content.

·       Drafting and reviewing professional, high-quality, and consistent CQV estimates and proposals.

·       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.  

Can provide consulting to clients for best-in-class CQV methods to include:

·       Integrated commissioning and qualification using a risk-based approach.

·       Quality risk management (QRM) implementation methods

·       CQV program assessment and associated optimization

·       Supplier assessment and audit

·       CQV methods for a broad range of life science equipment, facility and utility

·       Equipment and automation interface and integration

·       Project schedule acceleration with a focus on project delivery and product speed to market

·       Electronic validation life cycle management

Position Requirements:

·       BS or MS in a relevant science or engineering field, or equivalent

·       Seven (7) or more years in CQV SME or project manager for large CQV projects 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.

·       Able to travel domestically and internationally if required. 

About CAI

CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with 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 (our core values). That is how we have grown exponentially.

Benefits

Our full time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.

$115,000 - $140,000 a year

Average base salary range - not including benefits, metric based performance bonus, and/or Cost of Living Adjustment.

We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).