Lab Quality Coordinator

The Quality Coordinator is accountable for implementing routine and special clinical laboratory testing using automated semi-automated and/or manual methods and equipment (analysis includes Hematology Chemistry Urinalysis Immunoassay Coagulation and Biomarkers). Additional responsibilities will include quality control (including certification/accreditation ISO17025) validation of new assays training documentation of Analytical laboratory equipment use and maintenance (inventory and sample processing).

The Quality Coordinator brings support strategic direction including business performance for the Pfizer Clinical Research Unit Brussels activities and ensure the business continuity plan of our Safety analytical lab.

What You Will Achieve

In this role you will:

• Support for the analytical laboratory activities of the Pfizer Clinical Research Unit Brussels: Support routine and special clinical chemistry hematological coagulation and urinalysis and biomarkers Implement and validate new assays

• Perform all quality control checks monitoring trends (owner of the Quality Management System in the Laboratory). Check regularly control charts and manage the EEQ/CIQ program.

• Participate in quality lab projects related to ISO17025 or GCP and follow up with external suppliers. Implementation of the QMS (Quality management system) as required by ISO 17025 and GCP requirements.

• Implement & support the development validation and performance of biomarkers and routine clinical safety

• analyses to support PCRU BR need.

• Develops and maintains quality processes and SOPs in the Safety laboratory

• Ensure the control of the Safety laboratory environment safety specification maintenance and calibration of laboratory material required to conduct clinical activities.

• Ensure Safety Laboratory readiness for audits. Host and respond to internal and external Quality audits.

  be responsible for the planning of internal audit within the Laboratory monitoring of report and lead

  the closing meeting.

• Review protocols and provide feasibility assessments on ability to perform laboratory requirements and procedures

• & ensure clinical trials are conducted according to the protocol requirement objectives and timelines. Direct collaboration with the Laboratory team to execute and coordinate the qualitative actions within the framework ISO 17025 and GCP requirements.

• Responsible for maintaining/demanding ISO17025 accreditation/certification of our Safety Laboratory.

• Assure accurate collection and processing of biological specimens to assure quality of analytical data.

• Assure compliance of processes for all activity in the Safety analytical laboratory. Identify and implement new operational work process to improve Safety laboratory efficiency.

• Integrate and monitor quality indicators (key performance indicator) handle non-conformities and claims as well as corrective and preventive actions. Follow-up of all discrepancies and close collaboration with the Quality Compliance Manager(s).

• Prioritize and coordinate all efforts within the PCRU and collaborate between disciplines/divisions (Clinical Development Clinical Research Operations Clinical Pharmacokinetics Pharmacogenetics and other Clinical Research Units) to resolve issues and accomplish organizational goals.

• Explores coordinates and assures implementation of emerging Biospecimen Laboratory technologies/techniques to enhance the PCRU Brussels capabilities efficiency productivity competitiveness and data quality.

• Fosters open communication as a vehicle to ensure alignment and harmonization of PCRUs strategies and best practices.

• Represent the PCRU on global initiatives as a Laboratory Quality subject matter expert including regular interaction with the New Haven PCRU for best practices and complementarity.

• Perform other related duties incidental to the work described herein.

• Responsible for complying with Pfizer Standards ethical standards ICH regulatory and legal requirements national and European laws on health and safety at work fire prevention and other appropriate legislation

Here Is What You Need (Minimum Requirements)

• Minimum of a Diploma bachelors degree in medical biology or equivalent
• Significant track record of experience and accomplishment in clinical and/or research laboratory setting.
• At least 3 years of Clinical Research or experience in analytical techniques and full knowledge of analytical validation procedure is required. Thorough knowledge of clinical pharmacology and regulatory requirements (GLP GCP ISO17025 or ISO15189).
• Strong project management skills with the ability to drive critical projects to completion within agreed timelines
• Excellent oral written and interpersonal communication skills in French and English.
• Demonstrated ability to work independently and manage multiple priorities
• Proficiency in data analysis and problem-solving
• Experience in leading and mentoring teams
• Demonstrate ability and flexibility (regular on-call duty 24/7) in case of urgency to ensure safety coverage of volunteers/patients and clinical trials.

Bonus Points If You Have (Preferred Requirements)

• Masters degree coupled with relevant pharmaceutical experience
• Demonstrated expertise in defending work during regulatory audits
• Proven experience in leading continuous improvement projects
• Solid understanding of lean manufacturing Six Sigma methodologies and statistical analysis
• Excellent organizational and planning skills

Pfizers aim is to provide equality of opportunity in the recruitment process by avoiding any bias or potential discrimination on any grounds including (but not limited to): sex age race religion or belief sexual orientation or disability. At Pfizer we are creating an organization and promoting a culture that respects each individuals unique character and life experiences and reflects the diversity of our society customers and markets. We will achieve this through fostering and sustaining an environment in which every colleague feels valued and supported.

Disability Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

Handicap & Inclusion

Notre mission est de libérer le potentiel de nos collaborateurs et nous sommes fiers dêtre un employeur inclusif pour les personnes handicapées garantissant ainsi légalité des chances en matière demploi pour tous les candidats. Nous vous encourageons à donner le meilleur de vous-même en sachant que nous apporterons tous les ajustements raisonnables pour soutenir votre candidature et votre carrière future. Votre expérience avec Pfizer commence ici!