Freelance/Contract Senior QA/Qualified Person Consultant

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Opportunity

ProPharma continues to be a key partner of a global Life-Sciences brand as we are now helping them with a new Quality Assurance project for their activities in Israel. This role is to lead their Quality Assurance activities within the country and to be their acting Qualified Person. The project is to commence immediately; it requires 20-40 hours per week availability (flexible amount) and it will run initially for 6 months with an extension very likely to a year at least. The role will require frequent trips to their site near Tel-Aviv while the rest of the time it can be performed remotely.

Responsibilities

• Establish the local QA System (GMP/GDP) to all necessary regulations
• Act as the official Qualified Person (QP) with responsibilities for Batch certification and product release
• Provide Quality oversight to QA operations which includes governance of GXP activities and 3rd party providers
• Ensure full quality oversight of: importation, storage, distribution and product disposition
• Manage Quality/Technical Agreements
• Lead training program for GxP personnel
• Act as lead for: deviations, CAPAs, change controls complaints, returns, recalls, temperature excursions
• Ensure inspection readiness and act as host for MOH inspections
• Maintain full ownership of QMS documentation and SOPs
• Oversee quality aspects of product launches
• Support regulatory submissions and lifecycle activities
• Review batch documentation and PQRs
• Support artwork and risk management activities
• Ensure alignment of global and local regulatory requirements

Skills required

• Must be educated as a licensed Pharmacist within Israel
• Must have a demonstrated and extensive background working in Quality Assurance within the life-sciences industry
• Can demonstrate key experience working as a Qualified Person in Israel (a must)
• Fluent in Hebrew and English
• Extensive skills in GDP/GMP QA and working with 3rd party suppliers
• Audit experience is highly preferred
• Strong project leadership skills
• Can perform the project set out in the job description

Additional information

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***