Key Responsibilities
As 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. You will actively participate in business development activities, including marketing, direct sales, and sales support across various regions in Europe.
Responsibilities Include:
* Collaborate with cross-functional teams to deliver strategic project work.
* Leverage professional networks 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; contribute to the development of standards or guidance documents within these groups.
* Possess a network of industry contacts who recognize you as an expert in Quality and Compliance.
* Create and contribute to content that supports industry-leading approaches, enhancing our 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.
* Fulfill 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 specialized expertise.
* Build and maintain strong relationships with EU regulatory authorities and other relevant stakeholders to ensure access and influence.
* Develop and mentor agents through structured professional development plans and initiatives
Requirements
This role requires a hybrid work environment with on-site presence required as needed across European client sites.
Desirable Qualifications
Minimum 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).
Leadership and Communication Skills
The successful candidate will lead and mentor teams, influencing peers and stakeholders to achieve results. Effective communication skills are essential, including the ability to write technical documents, present business ideas, and foster collaboration.
Decision-Making and Business Acumen
The candidate will make sound, timely decisions that benefit the team and organization, gathering relevant information, asking insightful questions, and collaborating to identify optimal solutions. They will also demonstrate business acumen, delivering quality work, identifying improvement opportunities, and simplifying processes.
Regulatory and Data Compliance Expertise
The successful candidate will have knowledge of EU and international data regulations, ensuring integrity, security, and compliance.
Technical and cGMP Expertise
They will be skilled in cGMP environments, covering manufacturing practices and quality systems.
Learning Agility and Problem-Solving
Adaptability, resolving issues effectively, planning independently, and working well in teams are essential qualities for this role.
Positive Influence and Relationship Building
The successful candidate will identify and address problems, take initiative, seek feedback, and drive continuous improvement. They will maintain strong relationships at all levels, share knowledge, and collaborate constructively.
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