A client of mine has a requirment for a Senior QA Associate for a Pharmaceutical project in the Leiden, Netherlands.:

Job Description (Sr) QA Associate:
Our company is in search of a dedicated individual to bolster our Quality team in the role of a (Senior) Quality Specialist. The primary duty of the (Sr) Quality Specialist is to offer Quality Oversight for all aspects of the project, guaranteeing that the new facility and its operations are suitable for use and conform to all cGMP (and BSL) standards.

To succeed in this role, we require applicants with exceptional communication skills, a risk-based mindset, the ability to focus on both the big picture and small details, and an impressive leadership style that motivates and drives Quality decisions. Overall, we seek a well-organized and engaging leader who is committed to delivering outstanding results.

Key Responsibilities:

• As a (Senior) Quality Specialist, you will play a crucial role in ensuring compliance with all regulatory requirements, particularly in relation to the pharmaceutical industry, health and safety requirements, environmental legislation, and cGMP requirements
• You will take the lead in Quality Risk Assessments and ensure that adequate mitigations are implemented in a timely manner
• Be responsible for setting up the Quality processes and its documentation/systems needed to ensure that the new facility and its operations meet all cGMP (and BSL) requirements
• You should possess outstanding leadership qualities, strong communication skills, a risk-based mindset and attention to detail to ensure proper training is provided for these processes
• You will explore opportunities to introduce emerging technological/digital solutions in Quality and drive these to implementation
• Additionally, you will support and approve non-conformance investigations and appropriate corrective/preventive action plans while raising serious quality, compliance, and/or GMP incidents to Department or Project/Site Management
• Finally, you will enjoy working closely and effectively with colleagues at the site and globally on sharing best oractices and exceeding customer needs.

Qualifications:

• The ideal candidate should possess a minimum of 4-6 years of experience in Quality within the biotechnical or pharmaceutical industry, specifically in a GMP regulated environment.
• A Bachelor's or higher degree in relevant fields such as Biochemistry, Biology, or Pharmaceuticals is also required.
• Demonstrated experience in ensuring compliance with regulatory requirements, leading teams, and implementing quality processes and documentation.

Experience and Skills:
Required:

• The ideal candidate should have a strong grasp and practical application of worldwide regulatory standards such as cGMp, ICH, FDA, and EMA
• They must be an independent problem-solver who can navigate complex situations by balancing business requirements, regulatory compliance, and cost-effectiveness, while making quality decisions
• The candidate should be able to foster teamwork in a fast-paced environment and should be an excellent communicator who can lead by example
• They should also be able to manage diverse viewpoints and embrace diversity, while being an empowered professional who can drive a quality mindset and make pragmatic decisions independently.

Preferred:

• Having prior experience in Tech Transfer and Risk Assessments would be highly advantageous
  

Other:

• Excellent communication skills in written and verbal English are a must-have for this position
• Although there is limited travel involved, the candidate should be prepared to work on-site when necessary to meet the demands of the work