Lead Consultant - Compliance Solutions at Zifo! - Based Europe

We’re seeking an experienced, motivated, enthusiastic, and curious person with a solid understanding of validation and compliance within Drug Discovery to grow our services business with a core focus on developing and expanding our Compliance Solutions and Services portfolio from Early Discovery to Manufacturing and Batch Release.

The ideal candidate will be a skilled, self-motivated individual that can propose, design, implement, and support compliance and validation solutions, remain close to the science and maintain a solid understanding of the business outcomes from the data, systems, technologies and regulatory environment.

The successful candidate will lead strategy, the team, pre-sales, customer engagements, services and solutions for Pharmaceutical and Biotechnology Research and manufacturing organisations.

About You:

We think that a person with a Product Management, Solutions, Consulting, Professional Services or Technical Pre-Sales background and relevant domain experience will be most suited to this role. Please keep in mind the following description reflects the profile we believe would best fit the role.

Passionate Problem Solver: You are curious with a genuine interest in solving customer problems and courage to tackle diverse and complex data challenges. Your logical problem-solving skills contribute to innovative solutions.

Team Builder and Business Enthusiast: You are genuinely interested in building and leading a team. Your commitment extends to fostering collaboration, both within and outside the team, and growth of a new business.

Continuous Learner and Technical Expert: You are eager to learn, adapt, and share your expertise as a leader while being committed to staying current with fundamental theory, principles, and advancements in science & technology.

Effective Communicator and Collaborator: Confidently liaising at all levels, both internally and externally, coupled with creativity and flexibility to thrive in a collaborative, multi-disciplinary environment with productive relationships.

Customer-Centric and Approachable: You prioritize customer satisfaction and your commitment to managing priorities and encouraging interaction fosters a positive and supportive working environment.

Scientific Relationship Builder: You actively work to strengthen our relationships with scientists, enabling their research. Providing bioinformatics expertise, you contribute to the growth and development of those around you.

Adaptable and Proactive Team Player: You have a self-motivated growth mindset, can lead in a flexible environment with change and ambiguity, maintain a positive attitude and seek opportunities for personal and team development.

Travel Enthusiast: You are willing to travel, visit customers and speak at conferences to build relationships with industry contacts and customers.

What you will be doing…

If you are confident that you can ramp up quickly, we would like to get to know you and look forward to receiving your application!

Commercial:

Commercial Strategy Development: Building and expanding the business, developing compliance solutions using your network of industry contacts, customer insights, market assessments, partnering and marketing. Developing Strategy, Value Propositions, Customer Solutions, and a Services Portfolio that generates leads and wins opportunities. Participate in conferences, proposals, and retrospectives to successfully secure projects to grow the local and remote practice.

Global Growth & Collaboration: Forecast and monitor demand, capacity, people, in-time recruitment, competency, and skills development. Create opportunities to pull work forward, accelerate existing work, allocate the team, facilitate global working, and nurture our values.

Solution Development: Oversee the Proposal, design, implementation, and development of Customer Solutions for Compliance Services and Solutions from Discovery to Post Market Surveillance.

Point of Contact: Be the primary contact for the Practice, Team and Customer.

People:

Team Leadership and Management: Servant Leader that can mentor and motivate consultants and proactively develop talent, capability, and competency. Partner with other regions ensuring coordination and cohesion with international colleagues. Ensure equitable workload distribution.

Recruitment: Identify and communicate hiring and internal transfer needs, aligned with the current pipeline, geography, skills distribution, and growth objectives. Participate in the hiring process, ensuring the seamless onboarding and early contribution for new team members.

Science:

Industry / Domain Expertise: Experience in assuring compliance across different drug modalities e.g. biologics, antibodies, proteins, peptides, cell & gene therapy, nucleotides, vaccines and omics.

Technical:

Validation & Compliance: Lead and execute Instrument Qualification (IQ/OQ/PQ) for laboratory equipment, manufacturing systems, and other critical instruments in line with GxP requirements. Perform Computer Systems Validation (CSV) across software and automated systems, ensuring compliance with regulatory guidelines (FDA 21 CFR Part 11, EU Annex 11). Implement Computer Software Assurance (CSA) approaches to minimize validation burden while maintaining quality and compliance. Develop, execute, and document validation protocols (IQ, OQ, PQ, UAT) and risk assessments.

Artificial Intelligence / Machine Learning (AI/ML) Compliance: Develop and apply validation strategies for AI/ML systems in line with industry best practices and regulatory expectations. Ensure that AI/ML models used in decision-making processes meet the requirements for transparency, reproducibility, and data integrity. Oversee AI/ML algorithm testing, monitoring, and documentation to maintain GxP compliance.

Data Governance & Data Provenance: Lead initiatives to establish and maintain strong data governance frameworks, ensuring data integrity, accuracy, security, and compliance with regulatory standards. Manage data provenance to ensure traceability, authenticity, and the integrity of the data lifecycle, especially in highly regulated environments. Collaborate with cross-functional teams to ensure data practices comply with internal policies, regulatory requirements, and industry standards.

Regulatory Compliance & Audits: Stay current with regulatory requirements (FDA, EMA, ISO) and guidelines impacting biotech and pharma operations. Act as the subject matter expert (SME) during internal and external audits related to CSV, CSA, AI/ML, and data governance. Prepare audit documentation and provide CAPA (Corrective and Preventive Actions) and continuous improvement recommendations to ensure ongoing compliance.

Delivery:

Allocation: Maintain control over team and project allocation to minimize non-billable and bench time by ensuring optimal use of skills and people. Proactively plan, manage, and communicate utilization and realisation. Drive efficiency and scaled execution by moving work to the remote team when feasible.

Reporting: Ensure up to date and timely reporting on Opportunities, allocation and Data that enables insights into the practice area. Use the designated systems, ensuring on-time and accurate data representation. Ensuring on-time billing, reporting, monitoring, and governance across the practice.

Qualifications:

Candidates without a higher degree are encouraged to apply if they possess a strong background within the biotech/pharma industry.

Hold a higher-level degree or possess equivalent experience in Molecular Biology or bioinformatics-focused disciplines such as Computational Biology, Genetics, Bioinformatics, Cancer Biology or Applied Statistics/Mathematics.

About Zifo:

Zifo RnD Solutions is a fast-growing global organization with a presence in US, UK, Germany, France, Japan, China, Singapore, Switzerland, Spain, Ireland, Canada and India. Zifo helps organizations strategize, design, implement and support their systems in the areas of Laboratory Informatics, Scientific Data Management, Clinical Biometrics, Genome Informatics and Compliance Solutions.

If you are attracted by the idea of joining a team where the employee is integral to the success of the company, where trust, empowerment and self-development are more than just words…. then Zifo could be the Company for you. Here at Zifo, these values are the backbone of our culture.

We offer an attractive salary in addition to an excellent benefits package and look forward to receiving your application. Send your resume to eu.careers@zifornd.com and visit our website at www.zifornd.com.