CAI

Associate Director QCR

Italy

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Medical Devices, Life SciencesIndustries

Requirements

Candidates should possess a Bachelor’s, Master’s, or PhD in Biotechnology, Chemistry, Pharmaceutical Manufacturing Technology, Industrial Pharmaceutical Science, Pharmaceutical Technology and Quality Systems, Engineering, or a related scientific discipline, combined with at least 10 years of experience in the life sciences industry (Pharma, Medical Device, Biotech, etc.), with a proven track record of leading or collaborating effectively within cross-functional teams. In-depth knowledge of cGMP systems, Quality Assurance, regulatory affairs, pharmaceutical manufacturing, and testing, with direct experience in manufacturing environments is required, and prior experience in sterile manufacturing, biotechnology, medical devices, and/or Cell and Gene Therapy is highly advantageous. Demonstrated technical leadership in the development and implementation of Quality Management Systems (QMS) is also necessary.

Responsibilities

The Associate Director QCR will serve as both a strategic leader and subject matter expert, building, expanding, and leading the Practice Area function across Europe, ensuring excellence in service delivery, operational readiness, and execution. They will actively participate in business development activities, including marketing, direct sales, and sales support across various regions in Europe, leveraging their professional network to attract new business opportunities and secure assignments for consultants. The role involves creating and contributing to content that supports industry-leading approaches, consulting clients in the areas of Quality, Regulatory, and Compliance, providing significant support to the Practice Area Leader with respect to quality systems, knowledge management, service definition, and delivery, and engaging in strategic project work. Furthermore, the Associate Director will fulfil Quality, Regulatory, and Compliance roles while managing client relationships, develop and mentor CAI agents through structured professional development plans, and build and maintain strong relationships with EU regulatory authorities and other relevant stakeholders.

Skills

Quality Compliance
Regulatory Affairs
Business Development
Sales
Client Relationship Management
Knowledge Management
Service Delivery
Strategic Leadership
Network Building
Content Creation
Industry Forums
Speaking Engagements

CAI

Consulting for operational readiness in healthcare

About CAI

CAI Technical Consulting Malaysia SDN, under the brand cagents.com, offers consulting services focused on operational readiness for clients in the pharmaceutical, biotechnology, and healthcare sectors. They conduct operational readiness assessments to evaluate a company's preparedness and tailor their services accordingly, which include project planning and asset management. CAI stands out from competitors by emphasizing professional development and industry collaboration, ensuring their team stays updated on industry trends. Their goal is to help clients achieve operational excellence and readiness for full-scale production.

Overland Park, KansasHeadquarters
1996Year Founded
$3.4MTotal Funding
PRE_SEEDCompany Stage
Industrial & Manufacturing, Biotechnology, HealthcareIndustries
1-10Employees

Benefits

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

Risks

Competition from specialized firms in digital transformation may erode CAI's market share.
In-house consulting teams in corporations could reduce demand for CAI's services.
Remote work models decrease demand for traditional on-site consulting, impacting CAI's operations.

Differentiation

CAI offers comprehensive consulting services across multiple industries, including life sciences.
Their expertise in energy management aligns with the sustainability focus of data centers.
CAI's risk management services cater to the growing cybersecurity needs in process manufacturing.

Upsides

Demand for digital transformation in life sciences boosts CAI's automation consulting services.
Personalized medicine trends create opportunities for flexible manufacturing process consulting.
Data centers' focus on energy efficiency aligns with CAI's energy management expertise.

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