Quality Assurance Analyst

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice, is searching for a Quality Assurance Analyst to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work in a hybrid model in Leiden, 1.0 FTE. The position is open to both freelancers and employees with a one-year fixed-term contract.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  

Scope of the role:

In this position you will ensures a professional, up to date, high quality level of Company’s core Quality Systems and its application of these systems to maintain and improve the compliance status of Company’s processes and systems in line with the regulatory, Company Supply Chain and Company standards. Develops and updates quality systems and procedures when appropriate. Advises Q&C Management and the executing departments regarding compliance issues and ensure resolution.

 

Main Job Tasks and Responsibilities:

• Acts as a Center of Expertise for GMP core quality systems. Maintains and improves GMP core quality systems, ensuring that the Company quality systems are compliant, state-of-the-art, and efficient.
• Ensures consistency in the quality systems across processes and departments.
• Has an outstanding knowledge of GMP regulations, Company standards and translates these requirements in company systems that are compliant.
• Is responsible for the Inspection Readiness program for the quality systems under his/her responsibility ensuring company in compliance with the GMP regulations and has a high First Time Pass for all regulatory inspections.
• Performs internal audits as a (lead/team) auditor. Identifies critical areas for improvement through audits and assessments and prioritizes and executes the compliance improvements initiatives resulting from this.
• Uses appropriate assessment tools (e.g., PE, Lean, Risk Management principles) in assessing the status of current quality processes and in introducing improvements.
• Ensures that quality initiatives are implemented effectively across all relevant operational (Quality) departments.
• Defines the skill requirements and develops GMP training programs on quality systems for Company employees. Ensures that appropriate GMP training is given on these systems.
• Act as Quality contact for core quality systems in the Company organization and internationally.
• Ensures that Company needs, and requirements are well positioned.
• Maintains a relevant network of contacts with compliance specialists within the companies, but also with other pharmaceutical companies and professional associations, which will allow him/her to identify best practices for various quality systems.
• Ensures good communication with all departments and functional groups within company involved in GMP work. Ensures that company management stays adequately informed.
• Ensures that performance, quality, and compliance reviews are made, followed up and shared with upper management.
• Acts as a major contact for quality systems questions during regulatory inspections and 3rd Party audits.
• Advises management on major quality systems related issues and communicates recent developments with regards to standards and cGMP in his/her area.
• Responsible for all project aspects of GMP improvement initiatives carried out under the jobholder’s responsibility, such as quality, planning, budget, and communication.

 

Education and Experience:

• Master’s degree or equivalent in bioscience, pharmacy or other related field; supplemented with additional training during work life.
• Extensive knowledge of Quality Systems in a cGMP environment.
• Advanced courses on cGMP Internal: preferable: Process Excellence/Lean belt, Risk Management and Auditing experience.
• Pharmaceutical or related industry work experience for 8-10 years, of which a substantial part in quality or compliance functions.
• Experience in a complex, multinational work environment/company.
• Analytical, innovative, and pragmatic thinking.
• Proven leadership skills in a professional environment, including coaching or supervising multidisciplinary teams.
• Excellent communicational and advisory skills, result oriented.
• Proficiency in written and oral English, with a desirable command of Dutch.

 

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

 

Who will you be working for?

 

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       

 

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

 

Key words: Quality Control Analyst, Quality Assurance, Quality systems GMP, Audit, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.

 

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