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- Tasks: Lead and expand the Quality Compliance and Regulatory Practice across Europe.
- Company: Join CAI, a leader in life sciences consulting, driving innovation and excellence.
- Benefits: Enjoy a hybrid work model with competitive salary and professional development opportunities.
- Why this job: Be a strategic leader influencing industry standards while mentoring future talent.
- Qualifications: 10+ years in life sciences with expertise in Quality Assurance and regulatory affairs required.
- Other info: Travel across Europe is necessary; must work in the EU without visa sponsorship.
The predicted salary is between 115000 - 135000 £ per year.
4 days ago Be among the first 25 applicants
The Position is Hybrid, not 100% remote (many projects will require on-site presence)
Position Description:
As the Associate Director within the Quality Compliance and Regulatory Practice Area at CAI, you will serve as both a strategic leader and subject matter expert. You will be responsible for building, expanding, and leading the Practice Area function across Europe, ensuring excellence in service delivery, operational readiness, and execution.
This role involves active participation in business development activities, including marketing, direct sales, and sales support across various regions in Europe. You will also play a key role in designing and implementing systems, processes, and initiatives that drive sustainable business growth.
The Associate Director will report directly to the Practice Area Leader (PAL) for Quality, Compliance, and Regulatory Affairs (QCR).
Specific Responsibilities Include:
- As a leader, work collaboratively with CAI agents to sell QCR services and deliver strategic project work.
- Leverage your professional network to attract new business opportunities, generate leads, and secure assignments for consultants through proactive and targeted sales efforts.
- Engage in industry forums, speaking engagements, article writing, and participation in professional society committees; support the development of standards or guidance documents within these groups.
- Possess a network of industry contacts who would recognise you as an expert in Quality and Compliance.
- Create and contribute to content that supports industry-leading approaches, enhancing CAI’s website and marketing materials.
- Consult clients in the areas of Quality, Regulatory, and Compliance.
- Provide significant support to the PAL with respect to quality systems, knowledge management, service definition, and delivery in your area of expertise.
- Fulfil Quality, Regulatory, and Compliance roles while managing client relationships for a portfolio of products, ensuring alignment with project schedules and stakeholder expectations.
- Engage in strategic project work that opens the door to broader team deployments or complements larger initiatives with specialised expertise.
- Build and maintain strong relationships with EU regulatory authorities and other relevant stakeholders to ensure access and influence.
- Develop and mentor CAI agents through structured professional development plans and initiatives.
________________________________________
Position Requirements:
- Work Environment: Hybrid role with on-site presence required as needed across European client sites.
- Education: 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 relevant industry experience.
Experience:
- Minimum of 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.
- 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).
________________________________________
Skills/Competencies:
- Leadership & Mentorship: Leads and mentors teams, influencing peers and stakeholders to achieve results.
- Communication Skills: Communicates clearly, writes technical documents, presents business ideas, and fosters collaboration.
- Decision-Making: Makes sound, timely decisions that benefit the team and organisation. Gathers relevant information, asks insightful questions, and collaborates to identify optimal solutions.
- Business Acumen: Delivers quality work, identifies improvement opportunities, and simplifies processes.
- Drive: Demonstrates initiative, self-management, and strong organisational skills.
- Regulatory & Data Compliance Expertise: Knowledgeable in EU and international data regulations, ensuring integrity, security, and compliance.
- Technical & cGMP Expertise: Skilled in cGMP environments, covering manufacturing practices and quality systems.
- Learning Agility & Problem-Solving: Adaptable, resolves issues effectively, plans independently, and works well in teams.
- Positive Influence: Identifies and addresses problems, takes initiative, seeks feedback, and drives continuous improvement.
- Relationship Building: Maintains strong relationships at all levels, shares knowledge, and collaborates constructively.
________________________________________
Other Requirements:
- Able to travel domestically and internationally across Europe as required
- Able to work in the EU without visa sponsorship now or in the future
€133,000 – €153,000 a year
The Position is Hybrid, not 100% remote (many projects will require on-site presence)
Other Requirements:
- Able to travel domestically and internationally across Europe as required
- Able to work in the EU without visa sponsorship now or in the future
Seniority level
-
Seniority level
Director
Employment type
-
Employment type
Full-time
Job function
-
Job function
Business Development and Sales
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Industries
Pharmaceutical Manufacturing
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Associate Director QCR employer: CAI
Contact Detail:
CAI Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director QCR
✨Tip Number 1
Network actively within the life sciences industry, especially focusing on Quality and Compliance. Attend relevant conferences and engage with professionals who are already in the field to gain insights and potentially secure referrals.
✨Tip Number 2
Showcase your expertise by contributing to industry forums or writing articles related to Quality Management Systems. This not only establishes you as a thought leader but also increases your visibility among potential employers.
✨Tip Number 3
Prepare for interviews by familiarising yourself with the latest trends and regulations in the EU life sciences sector. Being well-versed in current compliance issues will demonstrate your commitment and knowledge to the hiring team.
✨Tip Number 4
Leverage your existing professional network to gather insights about CAI and its culture. Understanding the company’s values and expectations can help you tailor your approach during discussions and interviews.
We think you need these skills to ace Associate Director QCR
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in the life sciences industry, particularly in Quality, Compliance, and Regulatory Affairs. Emphasise your leadership roles and any specific achievements that align with the responsibilities of the Associate Director position.
Craft a Compelling Cover Letter: Your cover letter should reflect your understanding of the role and the company. Discuss how your background in cGMP systems and Quality Management Systems can contribute to CAI's goals. Mention your network within the industry and how it can help drive business development.
Showcase Your Communication Skills: Since the role requires strong communication skills, include examples of how you've effectively communicated complex ideas or led teams. This could be through presentations, technical documents, or mentoring experiences.
Highlight Your Business Acumen: Demonstrate your understanding of the pharmaceutical manufacturing landscape and your ability to identify improvement opportunities. Include specific instances where you simplified processes or delivered quality work that had a measurable impact on your previous organisations.
How to prepare for a job interview at CAI
✨Showcase Your Leadership Skills
As an Associate Director, you'll need to demonstrate your ability to lead and mentor teams. Prepare examples of how you've successfully led projects or teams in the past, highlighting your decision-making process and the outcomes achieved.
✨Demonstrate Industry Knowledge
Familiarise yourself with the latest trends and regulations in the life sciences industry, particularly in Quality Compliance and Regulatory Affairs. Be ready to discuss how your expertise aligns with the company's goals and how you can contribute to their success.
✨Prepare for Business Development Questions
Since this role involves business development, think about your previous experiences in generating leads and securing assignments. Be prepared to share specific strategies you've used to attract new business opportunities and how you can leverage your network for CAI.
✨Engage with Relevant Examples
Use concrete examples from your past work to illustrate your problem-solving skills and adaptability. Discuss situations where you've had to navigate complex regulatory environments or implement quality management systems, showcasing your technical expertise.
