Quality Management System & Training Compliance Specialist

Company Description

Ergomed is a full service mid-sized CRO specialising in Oncology and Rare Disease.

Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia 

Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development.

We have nourished a true international culture here at Ergomed.

We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Job Description

The Quality Management System & Training Compliance Specialist is responsible for:

1. Providing ad-hoc support for all QM&C activities, both globally and cross-functionally. These responsibilities may include, but are not limited to, assisting in the development/revision of QM&C Department processes/procedures, reviewing, and providing input on cross-functional processes and procedures or Controlled Document Deviations and assisting with the governance, maintenance, and accuracy of QMS documentation / records.
2. Providing support to QM&C leadership during audits and inspections of Ergomed, including locating and QC of documents required by Auditors/Inspectors
3. Assisting in the creation, coordination and reporting of GxP training activities and/or programs for one or more Ergomed Group business entities.
4.  Supporting the provision of Ergomed CR staff training information/documentation during audits and inspections as it pertains to Ergomed Group.
5. Providing general administrative support for QM&C activities as they relate to ensuring quality and compliance for operational functions

Qualifications

Bachelor’s degree in relevant field of study and 2-3 years in Quality Assurance or equivalent combination of studies and work experience.

Knowledge of e.g., GCPs, ICH guidelines, FDA 21 CFR Part 11 and other applicable country regulations.

Ability to compile and interpret quality metrics

Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

We offer: 

• Training and career development opportunities internally

• Strong emphasis on personal and professional growth 

• Friendly, supportive working environment 

• Opportunity to work with colleagues based all over the world, with English as the company language 

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!

Quality 

Integrity & Trust

Drive & Passion

Agility & Responsiveness

Belonging 

Collaborative Partnerships

We look forward to welcoming your application.