Senior Quality Consultant/ Manager

The life sciences industry plays a significant role in advancing healthcare and improving the quality of life - in many cases, saving millions of lives globally. At BASE life science, this is the motivation for everything we do, aimed at pushing boundaries, seeking excellence, and making a lasting difference through consulting expertise and data-driven solutions.

**Who is BASE life science?**:
Founded in 2007, BASE life science is a business and technology consulting enterprise working exclusively in the life sciences industry.

From our headquarters in Denmark and offices in France, Germany, Italy, Spain, Switzerland, the United Kingdom, and the United States of America, we serve customers across the globe. With a deep understanding of the life sciences industry, we work hand in hand with customers to identify, develop, and implement strategic initiatives that drive growth, efficiency, and overall success through tailored solutions.

Our partnership with industry-leading solution providers, including Veeva, Salesforce, IQVIA, Benchling, and MediSpend ensures that our clients harness the full potential of the most innovative solutions on the market.

**About the role**:
As our new Quality consultant, you will work within an experienced and skilled R&D team where you will provide general support in assigned Quality projects and activities.

Particularly, you will contribute to the design, implementation and/or execution of various Quality processes and Quality related IT and AI solutions. Examples could be quality event process/solution design, document, and data management, whilst working closely with BASE colleagues located around Europe, USA and India.

You will be required to actively participate in relevant projects and activities and contribute to continuous quality improvement initiatives with timely execution of assigned tasks and appropriate quality outcome(s).

Additionally, you may be asked to attend conferences on behalf of BASE life science and other operational activities as needed.

This role is available at different levels of seniority, from Senior consultant to Manager.

As a Quality Senior Consultant/ Manager, here are some examples of potential project assignments and key your responsibilities:
**QMS Strategy, Design & Harmonization**
- Lead Phase 0 (preparation) workshops to assess current state, define future-state QMS process, and harmonize quality processes across global sites.
- Design scalable, compliant QMS frameworks aligned with GxP and Pharmaceutical Quality System (PQS) principles.
- Advise clients on best practices for QMS process standardization, tool selection, and digital transformation.

**Supplier Quality Management**
- Implement and support GxP-compliant third-party management processes including supplier qualification, audits, performance monitoring, and risk assessments.
- Integrate supplier quality workflows into enterprise QMS platforms.

**Data Analytics & AI Use Cases**
- Support the deployment of data analytics solutions to monitor quality KPIs, identify trends, and support proactive decision-making.
- Support the implementation of AI/Machine learning use cases such as predictive quality, intelligent document processing, and risk-based deviation analysis.
- Collaborate with data science and IT teams to embed analytics into QMS platforms.

**Business Analysis & Stakeholder Engagement**
- Facilitate workshops with cross-functional stakeholders to gather requirements and define solution scope.
- Translate business needs into functional specifications and system configurations.

We offer this position in Spain, Denmark or UK.

**What makes you the best person for this job?**:
To be considered for this position, we expect that you come equipped with:

- Bachelor’s or master’s degree in a technical, scientific, or medical/clinical discipline.
- Strong understanding of GxP and global regulatory frameworks and standards such as FDA, EMA, MHRA and ISO 9001.
- A minimum of 5 years “hands-on” quality expertise.
- Previous experience with Quality IT systems is preferred, e.g., Veeva Quality Vault, TrackWise, TrackWise Digital, ETQ Reliance, and MasterControl.
- Experience with quality processes such as deviations, CAPAs, change controls, risk management, vendor/supplier quality.
- Experience designing or improving quality processes e.g., creating SOPs.

**Key soft skills**:

- Experience training staff and/or with change management experience.
- Experience working with a wide range of technically and culturally diverse people.
- Excellent communication, facilitation, and stakeholder management skills.
- Strong communication skills in English, both verbal and written.
- Strong motivation to learn and develop interpersonal skills.
- Demonstrated ability to handle multiple projects/deadlines.
- Great focus and attention to detail.
- Ability to work both independently and within a team.
- Adaptable to new responsibilities.

**What makes us the best employer for you?**:
BASE life