Quality, Senior Manager, Research & Pre-Clinical

Basic qualifications:

  • MSc with at least 10 years in Pharmaceutical business covering various areas: Research, Pre-Clinical, Clinical Labs, Testing
  • Deep knowledge in quality regulation requirements covering GLP, GSP, GXP and general quality compliance
  • Good knowledge of animal testing
  • Strong sero-toxicology, clinical trials and laboratory process knowledge
  • Strong QA Experience in an FDA/EU regulated environment
  • Executive and leadership capability to manage people
  • Ability to lead, influence and convince people in a complex organization
  • Strong communication and presentation skills.
  • Ability to manage networks and build relationships transversally across the Vaccines network
  • Flexible thinking
  • In depth knowledge and expertise of quality systems, specially of key/ core, such as, Deviation/ Investigation, Documentation Management, Training, Change Control, CAPA, Product Disposition, Validation)
  • Good knowledge of quality and risk management principles and tools
  • Ability to adapt, work under uncertainty and accommodate flexible work demands
  • Global perspective; cultural sensitivity
  • Ability to withstand pressure, self-motivated

.

Preferred qualifications:

PhD with three plus years of experience Pharmaceutical business covering various areas: Research, Pre-Clinical, Clinical Labs, Testing

Details:

  • Ensure quality oversight and partnership for Research & Pre-Clinical Development Activities in Research & Development Center (RDC)
  • Supervises 4-6 direct reports & 12-14 indirect reports
  • Responsible for ensuring that the activities conducted in key research & pre-clinical laboratories (internal, external) are performed in accordance with GLP, GSP, GXP, local, corporate and relevant international regulations
  • Responsible for ensuring inspection readiness, Quality Assurance and support is provided to external regulatory inspections
  • Responsible for directing and controlling Quality Assurance responsibility for new activities/studies in the partner business unit, including sero-toxicology studies
  • Responsible to implement and monitor the GSK vaccines quality strategy within his/her remit
  • Can be responsible for supervising remote regional/global quality teams

Key Responsibilities

  • Develop, assure and maintain the quality of the vaccine research and pre-clinical testing processes
  • Standard procedures (worldwide regulatory requirements)
  • Research and Development Quality
  • Control the quality and accuracy of the data used in drug discovery
  • Guarantee that the R&D studies (discovery, preclinical, early clinical) are performed in accordance with Good Scientific Practices (GSP), GLP, local, corporate and international regulations
  • Define quality audit programs and follow-up on their implementation
  • Organize and take the responsibility for Quality Assurance in Research & Pre-Clinical activities for R&D Department
  • Establish SOP's for quality standard in collaboration with other departments and based on Global Quality Assurance and or corporate policies
  • Make sure that the records, SOP's and documentation have been completed and endorsed by the staff authorized to do so
  • Approve master records, procedures, validation protocols, results and conclusions
  • Make sure that any deviations, OOS, changes have been authorized by the persons responsible in accordance with procedures
  • If relevant, assure final approval in method validation
  • Ensure a continuous quality & compliance improvement mindset within his/her remit
  • Ensure inspection readiness and CAPA follow-up
  • In collaboration with audit team, prepare, participate to and assure regulatory inspections
  • Deep knowledge in quality regulation requirements covering GLP, GSP, GXP and general quality compliance
  • Good knowledge of animal testing
  • Strong sero-toxicology, clinical trials and laboratory process knowledge
  • Strong QA Experience in an FDA/EU regulated environment
  • Executive and leadership capability to manage people
  • Good knowledge of French and English (spoken and written)
  • Ability to lead, influence and convince people in a complex organization
  • Strong communication and presentation skills
  • Ability to manage networks and build relationships transversally across the Vaccines network
  • Flexible thinking
  • In depth knowledge and expertise of quality systems, specially of key/ core, such as, Deviation/ Investigation, Documentation Management, Training, Change Control, CAPA, Product Disposition, Validation)
  • Good knowledge of quality and risk management principles and tools
  • Ability to adapt, work under uncertainty and accommodate flexible work demands
  • Global perspective; cultural sensitivity
  • Ability to withstand pressure, self-motivated
  • Make sure that Business Monitoring (self-inspection) are performed
  • Assure internal self-inspection for his/her team
  • Make sure that commitments are followed up and implemented
  • Prepare and support the R&D Center for the audits run by GSK Corporate (L3 audit) and/or by external Health Authorities (L4 Audit)
  • Manage quality trends analysis/quality review/QA reports
  • Optimize and maintain the compliance level of the quality systems with Quality System and Services (QSS), regulatory, GSK corporate and GSK Vaccine standards in R&D Center
  • Ensure a consistent approach to the interpretation and implementation of GSP/GLP standards
  • Responsible for coaching, training, motivating and evaluating his/her direct reports through effective performance KPI's
  • Provide QA expertise and support to related teams
  • Responsible to ensure that standards GSK requirements in terms of research & pre-clinical activities are in line with authorities requirements within all laboratories internally to GSK worldwide and out-contracted by GSK (in collaboration with Third Party Oversight representative
  • Manage the QA R&D Research & Pre-Clinical team to ensure the compliance of the R&D Operations with GSK requirements

Contact information:

You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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