Senior Quality, Compliance & Regulatory (QCR) Consultant

Switzerland  /  Europe/Ireland  /  Full Time


About CAI
CAI is a 100% employee-owned company established in 1996, it has grown year over year to nearly 700 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 (employees) 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, including COVID19 Vaccines and therapies. 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.
 
Requirements include:
We are now seeking a Senior QCR (Quality, Compliance & Regulatory Consultant to join our growing operations in Switzerland. The role of a Senior QCR Consultant in CAI is to:
·       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
·       Builds and maintains strong relationships with the regulatory authorities and other stakeholders as appropriate to ensure ease of access and influence
·       Work collaboratively with other CAI agents to sell QCR services and provide strategic project work.
MINIMUM REQUIREMENTS
·       Minimum BSc., with Biological / Biotechnology degree an advantage.
·       Postgraduate qualification an advantage.
·       Customer-service focused
 
Experience Required
·       Minimum 10 years’ 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:
Skills/Competencies
·       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. German and/or French is a plus.
·       Able to travel domestically and internationally if required.

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