Quality, Compliance, & Regulatory Associate Director

Flexible - Depending Upon Candidate  /  Quality, Compliance, & Regulatory  /  Full Time


About CAI
CAI is a 100% employee-owned company established in 1996 that has grown to over 600 people worldwide. We provide quality and compliance, commissioning, qualification, validation, start-up and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
Please check CAI out on Glassdoor to get a better perspective on our culture. We are extremely proud that our employee owners and others have given us so many 5-star ratings.
 
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.
Employment 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.
CAI Quality and Compliance Associate Directors will be exposed to cutting edge technologies and project management practices 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.
 
Summary of Position
As a Discipline Lead (DL) for the Quality and Compliance Business Area at CAI, you are a leader and subject matter expert who is responsible for establishing, growing, and leading Quality and Compliance. The incumbent will engage in marketing, direct sales or sales support to regions and facilitate in the development and implementation of systems and initiatives to grow the business for long term success.  The incumbent will work for and report to the Quality, Compliance and Regulatory Affairs (QCR) business area leader (BAL)
 
Requirements include
 Position Description:  As a Discipline Lead for the Quality and Compliance Business Area at CAI, you are a leader and 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 Quality and Compliance.
2.     Create and contribute to content in industry changing approaches that will benefit CAI web site and marketing materials.
3.     Can provide consulting to clients in the areas of Quality and Compliance.
4.     Provide significant support to the BAL with respect to quality systems, knowledge management, services definition, and delivery in the DL’s area of expertise.
5.     Can act in a Quality and Compliance role including managing client relationships for a portfolio of products and be responsible for close liaison with the management/ other key personnel in line with time frames per the project schedule.
6.     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.
7.     Be responsible for the management of one or more Quality and Compliance life science projects, support the client in understanding the regulated environment by serving as an advisor on the cGMP guidelines and on industry practices and norms.
8.     Builds and maintains strong relationships with the regulatory authorities and other stakeholders as appropriate to ensure ease of access and influence.
9.     As a leader, work collaboratively with CAI agents to sell QCR services and provide strategic project work.
10.  Develop and grow others in developing our existing agents through execution of compelling development plans, special initiatives and/ or collateral duties .
 
MINIMUM REQUIREMENTS
Education required:
·       Minimum BSc., with Biological / Biotechnology degree an advantage.
·       Postgraduate qualification an advantage.
 
 Experience required:
·       Minimum 10 year’s experience in a QA or equivalent role.
·       Extensive experience in cGMP systems, pharmaceutical manufacturing and testing, experience must include role(s) in a manufacturing setting.
·       Sterile manufacturing and/or biotech experience distinct advantage
·       Managerial or Supervisory experience required.
·       Regulatory inspection experience leading a function or group experience preferred.
·       Quality Control Laboratory experience
·       Preferred experience including, but not limited to the following:
o   Application of cGMP to manufacturing and quality systems.
o   Batch release and investigations
o   Change Management and CAPA
o   Regulatory Affairs
o   Validation and Qualification
o   Technical Transfers
o   Statistical techniques
o   Electronic and paper Quality Management Systems
 
Skills/Competencies:
·       Ability to coach individuals and lead teams.
·       Collaborative
·       Self-motivated and self-managing.
·       Excellent oral and written communication skills
·       Able to identify, execute and prioritize work tasks/projects with an awareness of escalation responsibility as needed.
·       Critical problem-solving skills
·       Demonstrated data driven decision making ability.
·       Organizational and operational agility, able to operate at all levels of the organization and able to shift priorities successfully.
·       An understanding of the pharmaceutical industry and its unique business responsibilities
·       Excellent facilitation and presentation skills
·       Ability to plan, organize and prioritize.
·       Excellent technical and compliance based writing skills.
·       Ability to work with clients of a diverse incumbent skill base.
·       Ability to manage projects involving multiple functional groups.
·       Requires negotiation skills to effectively influence others.
 
Other Requirements:
Excellent oral and written English is required
Able to travel domestically and internationally if required 
Able to work in the US without sponsorship now or any time or in the future
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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