Senior QA Specialist -GLP & Preclinical Studies

Novocure is a global medical device company with R&D based in Haifa. The company is growing quickly as it commercializes TTFields therapy: a novel treatment for aggressive cancers using alternating electric fields.We are looking for a Senior QA Specialist -GLP& Preclinical Studies who is primary responsibility will be to monitor/quality assure GLP and non-GLP studies within tissue culture & animal studies environment.Additional responsibilities include establishment, oversight and management of preclinical internal inspections programs (both specific GLP study related and routine preclinical activities ) &support of GLP certification maintenance. ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Act as GLP SME internally and in front of external parties
• Manages the maintenance of GLP certification, including GLP external audits and adequate GLP QMS
• Full Quality assurance of GLP studies including, but not limited to protocol approval, study monitoring audits, review and approval of reports and protocol amendments and deviations.
• Collaboration with global QA and preclinical department to assure preparation and execution of calibration and maintenance of preclinical equipment.
• Develops and executes preclinical internal audits & routine inspection programs using a risk based approach and preclinical department needs
• Ensures that audit and review results are appropriately recorded, reported, and communicated and that corrective/preventive actions are properly completed and documented in a timely manner.
• Establishes and maintains SOPs and WIs as needed to standardize the preclinical activities and to ensure compliance with the applicable standards and regulations within the preclinical group
• Co-Develop, implement and maintain SOPs and WIs of daily activities in the preclinical laboratories (in vivo and in vitro).
• Works with preclinical and global QA to continually improve GLP QMS to support effective and efficient execution of studies within the GLP framework
• Review of preclinical logbooks
• Oversight of the archiving process of the logbooks (performed by GLP archivist)
• Identification of nonconformities and deviations in the daily preclinical lab activities and managing their resolution
• Responsible for CAPAs related to preclinical lab activities
• Developing quality metrics and monitoring trends for preclinical critical to quality aspects
• Prepares and presents the Quality Reviews and lessons Learnt for the projects based on the audits and inspections’ outcomes, issues and CAPAs, on a risk-based approach.
• Supports training activities to increase Quality Awareness and Inspection Readiness in relation to GLP and preclinical activities.
• Supporting preclinical vendor audits and qualifications

QUALIFICATIONS/KNOWLEDGE: Qualifications:

• At least Bachelor's Degree in Life Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.

Knowledge:

• At least five years’ experience in a quality assurance role in a GMP/GLP-regulated environment
• Working knowledge and experience in Quality Management Systems.
• Knowledge of FDA compliance standards, GLP regulations, ICH guidance
• No hesitation in working in an animal studies environment
• Hands-on experience in animal studies and/or tissue culture is an advantage
• Strong Knowledge of GMP and GLP principles with respect to FDA and OECD regulations and guidelines, local laws and legislations as well as corresponding regulations, norms and standards
• Working knowledge of FDA Guidance for Industry, Bioanalytical Method Validation
• Experience working in the Pharma industry/Laboratory is highly preferred
• Experience in data integrity and 21CFR Part 11 Compliance
• Experience in process validation, analytical method validation and equipment qualification
• Excellent documentation skills
• Strong written and verbal communication skills.
• Proficient in Microsoft Office tools and knowledge of other QMS software is a plus.
• Able to work on own initiative and as a team player;
• Good organizational skills with cultural awareness and sensitivity
• Able to build good, strong and positive working relationships, in cross-functional teams
• Efficiently interacting with internal and external stakeholders in a fast-paced and changing environment.
• Experience with product design and development is highly preferred
• Highly organized and detail-oriented.
• Experience with Regulatory Inspections.
• Fluent in English
• Flexible and quickly adaptable to change priorities.
• Having integrity and a strong work ethic
• Results and goals oriented

OTHER: Willingness to travel at least 20% of the time (international and domestic) ABOUT NOVOCURE: Our visionPatient-forward: aspiring to make a difference in cancer.Our patient-forward missionTogether with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.Our patient-forward values– innovation– focus– drive– courage– trust– empathy