Overview

Senior Manager R&D Quality Assurance Jobs in Swiftwater – Pennsylvania – USA at myGwork

Title: Senior Manager R&D Quality Assurance

Company: myGwork

Location: Swiftwater – Pennsylvania – USA

Type: Full Time

Category: Quality Control, Science

This position primarily supports Quality management and Compliance activities associated with  clinical trial testing operations within Sanofi Pasteur Swiftwater Global Clinical Immunology  Laboratories and R&D Analytical Sciences. In this senior role within the SWT R&D Quality  Operations team, the incumbent will:
Ensure clinical trial samples are tested in accordance with GCP, GCLP, related global and      local procedures to assure clinical data integrity and safeguard patient safety

Conduct risk-based GCLP or GMP internal and third party audits against an established      schedule

Lead and support the implementation and assessment of relevant site and global quality      systems

Lead or participate in local and global quality initiatives and continuous improvement      activities

Exercises sound judgement in planning, organizing and performing independent quality      assurance activities with effective collaboration within R&D SQO and stakeholders

Oversees the execution of the temperature excursion process for clinical trial material,      focusing on continuous improvements and alignment globally within SQO

This position requires a strong understanding of quality, and team leadership attributes as  the incumbent will provide day-to-day leadership to a team of individuals/professionals from  various R&D and/or QO departments to resolve problems or implement quality systems.
Key

Accountabilities:

Ensure an effective audit program by using the approved risk based audit process to plan and      coordinate the annual internal and third party audits

Ensure integrity and quality of clinical data generated within the laboratories through      routine study audits consistent with clinical trial protocols

Ensure appropriate quality support for preparing the laboratories for regulatory inspections      and in conduct of regulatory inspections

Ensure appropriate quality systems are maintained through quality review of deviations,      change controls, training program verifying effective implementation of CAPAs

Conduct routine quality management reporting in order to ensure deliverables, actions and      timelines are met

Participate in cross-functional teams with respect to GXP compliance and continuous      improvement

Education/Certification:
Master of Science Degree preferred, specializing in Biology, Microbiology, Biochemistry , or      similar discipline

Minimum Bachelor of Science Degree, specializing in Biology, Microbiology, Biochemistry , or      similar discipline

ASQ Certified or ISO Certified Auditor qualification or Quality System certification training      from a recognized institution are assets

Experience:

5 to 10 years related experience in the Pharmaceutical Industry

Minimum 5 years experience conducting Quality Audits

Excellent problem solving, report writing and communication skills based on global      interaction

Excellent knowledge standards under GxP , including GMP regulations for US, EU and      Canada.  Knowledge of GCP is an advantage

Ability towork and influence in a team environment

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers  committed to a culturally diverse workforce. All qualified applicants will receive consideration  for employment without regard to race; color; creed; religion; national origin; age; ancestry;  nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or  expression; affectional or sexual ori…

 

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