Bernadette Soudah Abou-Atta
QA, Compliance & Regulatory Professional
Haifa
Summary
QA and Compliance professional with extensive experience across pharmaceutical, medical device, and chemical industries. Demonstrated expertise in regulatory compliance, Quality Management Systems (QMS), batch release, and implementation of compliance policies. Proven ability to lead and coordinate cross-functional teams, ensuring adherence to GMP standards. Experienced in regulatory submissions, audits, and providing analytical support for informed quality decision-making.
Overview
20
20
years of professional experience
4
4
Languages
Work History
CQP – Batch Release Responsible
01.2022 - 01.2022
- Approved imports and raw material batches for production and distribution.
- Reviewed analytical results and validation protocols.
- Led deviation investigations and closure of CAPAs.
QA and Compliance & Regulatory Lead
Pharmaceutical Company
HAIFA, Israel
01.2025 - Current
- Full responsibility for organizational compliance with regulatory and quality standards.
- Managed and maintained the Quality Management System (QMS).
- Developed and implemented compliance policies and procedures.
- Oversaw supplier quality, including drafting and closure of Quality Agreements.
- Collaborated cross-functionally to ensure adherence to applicable regulations.
Quality Assurance & Regulatory Specialist
01.2021 - 01.2022
- Oversaw manufacturing quality and regulatory documentation.
- Managed product files, deviations, and supplier complaints.
- Supported regulatory submissions and approvals.
Regulatory Affairs & QA Team Leader – Manufacturing
01.2022 - 01.2025
- Led projects from development to manufacturing, ensuring compliance with regulations.
- Managed registration dossiers for multiple markets and updated product files.
- Supervised QA team, allocating tasks and supporting professional growth.
- Approved raw materials and batch release; monitored deviations and CAPAs.
- Coordinated with R&D, Manufacturing, Planning, Warehouses, and Validation teams.
Regulatory Affairs & Clinical Research Project Manager
Medical Device Company
01.2020 - 01.2020
- Supported FDA, Health Canada, and EU submissions.
- Prepared clinical documentation and monitored studies.
- Assisted in protocols, CRFs, reports, and scientific publications.
Regulatory Chemist
ICL – Israel Chemicals Ltd. (Fertilizers)
01.2018 - 01.2019
- Regulatory support for development products through approval for marketing.
- Preparation of regulatory dossiers and documentation.
Analytical Method Validation Coordinator – R&D
Novetide (Teva Group)
01.2017 - 01.2018
- Management of analytical method validation projects (end-to-end, hands-on).
- Training and mentoring analysts; performance monitoring.
- Support of manufacturing sites and execution of technical transfers.
- Writing and review of validation protocols and reports.
Analytical R&D Scientist
Novetide (Teva Group)
01.2014 - 01.2017
- Development of analytical methods for identification and quantification of APIs and impurities.
- Independent project management and mentoring of employees and interns.
Food Inspector & Coordinator
Ministry of Health – Port of Haifa
01.2009 - 01.2011
- Inspection and supervision of food facilities and imported goods at the port quarantine station.
- Sampling and laboratory coordination to ensure compliance with quality and safety standards.
Analytical Chemist – QC Laboratory
Dexcel, Or Akiva
01.2006 - 01.2009
- Conducted GMP documentation, stability testing, and validation of processes.
Education
M.Sc. - Biotechnology and Food Engineering
B.Sc. - Biotechnology and Food Engineering
References
Available upon request.
Skills
Quality, Regulatory & Compliance Leadership – GMP, GxP, QMS, regulatory strategy
Data-Driven Quality & Analytical Oversight
Strategic Problem Solving & Analytical Thinking
Risk-Based Decision Making & Governance
Cross-Functional Team Leadership & Collaboration
Assertive Leadership & Stakeholder Representation
Ability to Perform Under Pressure & Multitasking
Timeline
QA and Compliance & Regulatory Lead - Pharmaceutical Company
01.2025 - Current
CQP – Batch Release Responsible -
01.2022 - 01.2022
Regulatory Affairs & QA Team Leader – Manufacturing -
01.2022 - 01.2025
Quality Assurance & Regulatory Specialist -
01.2021 - 01.2022
Regulatory Affairs & Clinical Research Project Manager - Medical Device Company
01.2020 - 01.2020
Regulatory Chemist - ICL – Israel Chemicals Ltd. (Fertilizers)
01.2018 - 01.2019
Analytical Method Validation Coordinator – R&D - Novetide (Teva Group)
01.2017 - 01.2018
Analytical R&D Scientist - Novetide (Teva Group)
01.2014 - 01.2017
Food Inspector & Coordinator - Ministry of Health – Port of Haifa
01.2009 - 01.2011
Analytical Chemist – QC Laboratory - Dexcel, Or Akiva
01.2006 - 01.2009
Technion – Israel Institute of Technology - M.Sc., Biotechnology and Food Engineering
Technion – Israel Institute of Technology - B.Sc., Biotechnology and Food Engineering