CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 670 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to quality and operational readiness to EU and 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.
JOB DESCRITPION SUMMARY:
As a Principal Consultant of Quality, Compliance and Regulatory Switzerland business at CAI, you are a subject matter expert with excellent knowledge of all aspects of Quality Assurance, Validation, EU and US Regulations, and have proven ability to manage projects with excellent problem solving and technical writing skills. The incumbent will work for and report to the Country Manager / Director of Operations Switzerland.
RESPONSIBILITIES (Essential Functions):
· Manage and execute projects to deliver special expertise, also in multiple sites simultaneously. And also engage in strategic project work designed to be a door-opener for larger teams once the initial expert engagement is over.
· Be responsible for the management of 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.
· Provide significant support to the Country Manager /Director of Operations with respect to quality systems, knowledge management, services definition, and delivery in the area of expertise.
· Act as internal source of knowledge in support of proposals.
· Assist in the development and application of appropriate quality technology tools to establish and increase quality and compliance client base.
· Research organization and individuals to find new opportunities.
· Increase the value of current customers while attracting new ones.
· 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.
· Builds and maintains strong relationships with the regulatory authorities and other stakeholders as appropriate to ensure ease of access and influence.
· Support the development and grow of junior agents through execution of compelling development plans, special initiatives and/ or collateral duties.
· 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.
· Participate actively on cross-functional operational and process improvement teams.
· BSc., MSc, with Biological / Biotechnology degree, Pharmaceutical Science, Biochemistry, Chemistry or related fields.
· Postgraduate qualification (PhD) an advantage.
· QP certification: distinct advantage
· Minimum 10 years’ experience in a QA or equivalent role, including Validation.
· Extensive experience in cGMP systems, pharmaceutical manufacturing and testing, experience must include role(s) in a manufacturing setting.
· Regulatory inspections experience leading a function or group.
· Quality Assurance representative and decision maker for investment projects.
· Sterile products manufacturing and/or biotech experience distinct advantage.
· Managerial or Supervisory experience distinct advantage.
· Quality Control Laboratory experience: advantage.
· Demonstrated experience or certification of project management: distinct advantage.
· Preferred experience including, but not limited to the following:
o Application of cGMP to manufacturing and quality systems.
o Management of QMS
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
· Ability to coach individuals and lead teams.
· Self-motivated and self-managing.
· Excellent oral and written communication skills
· Able to identify, plan, 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.
· Proficient knowledge of executing SAP, Trackwise and GLIMS.
· 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.
· Languages: fluent in at least two languages English, German (distinct advantage), or French (distinct advantage)
· Able to travel domestically and internationally.