QMS Ownership & Hands-On Operations

• QMS Maintenance: Maintain and improve the QMS to ensure full compliance with ISO 13485 and EU /MDR / IVDR / QMSR / ISO 27001
• Document Control: Manage the document control process, including Device History Files (DHF) and Device Master Records (DMR).
• NC, CAPA & Complaints: Lead investigations for nonconforming products, customer complaints, and Corrective and Preventive Actions (CAPA).
• Core Processes: Execute daily activities for change control, deviations, training control.
• CRB Chair: Chair the Corrective Action Review Board (CRB) meetings.
• Supplier Management: Maintain the Approved Supplier List (ASL), approve new suppliers, manage Supplier Corrective Action Reports (SCARs), and approve Quality Assurance Agreements (QAA).
• Executive Oversight: Lead management reviews, facilitate and track QMS objectives, and execute quality plans.
• Leading 3^rd party Audits: Lead ISO 13485, MDR, IVDR, audits

Production & Operations Support

• Product Release: Perform Device History Record (DHR) reviews, approve QC tests, and grant final product release.
• Facility Control: Oversee equipment maintenance, calibration activities, and environmental monitoring.
• Operational Quality: Initiate, investigate, and approve deviations and Non-Conformances (NCs).
• Incoming Goods: Oversee purchasing controls and perform incoming inspections for materials.

Cross-Functional Support

• Regulatory Affairs: Support technical documentation maintenance, labeling updates, standards monitoring, Post-Market Surveillance (PMS), and adverse event reporting.
• Commercial Support: Review customer orders and assist marketing with technical requests as needed. Support and facilitate feedback process.
• Culture: Advocate for QMS compliance and build a strong quality culture across the company.

Desired experience and skills:

• Technical or scientific degree
• Minimum 5 years of quality assurance experience in the medical device industry.
• Direct hands-on experience with various EU Classes including IIb or Class III medical devices.
• Ability to switch easily between high-level strategy and daily hands-on tasks
• Proven track record with EU MDR / IVDR and ISO 13485 audits.
• Ability to deliver results. Effective communication, collaboration, and flexibility to learn new work environments and relationships with customers.
• Fluent in English.
• Advantage: Experienced as consultant
• Advantage: experienced with sterilization processes Gamma / EtO

 Pharmaceutical Quality Project Manager

Position Overview

GSAP is seeking a Pharma Quality Project Manager to lead and support projects in Southern Israel. This is a diverse role that includes working closely with clients, leading quality and compliance processes, and creating broad professional impact.

Key Responsibilities

Quality Project Management

• Manage and provide professional support for pharmaceutical quality projects in accordance with client requirements and applicable regulatory standards.
• Lead quality and compliance activities in a dynamic, cross-functional environment.
• Work independently at client sites while collaborating with professional and management interfaces.

GMP Compliance and Quality Activities

• Lead quality activities in accordance with GMP principles and requirements.
• Support the implementation, maintenance, and continuous improvement of quality processes within regulated environments.
• Ensure all activities are conducted in compliance with procedures, client requirements, and relevant standards.

Quality in the API Industry

• Manage and support quality processes related to the manufacturing of Active Pharmaceutical Ingredients (API).
• Provide professional support for manufacturing, documentation, compliance, and quality control activities within API environments.
• Collaborate with quality, manufacturing, and operations teams and other interfaces.

Client and Interface Management

• Manage and maintain ongoing relationships with clients and cross-functional interfaces.
• Serve as a key point of contact for client quality-related needs, ensuring timely and effective support.
• Coordinate project activities and facilitate communication among relevant functions to achieve project objectives.
• Build collaborative working relationships and ensure effective communication throughout all project phases.
• Work independently, demonstrating ownership, accountability, and attention to detail while ensuring successful project execution.

Requirements

• Minimum of 3 to 5 years of experience in Quality Assurance and/or Compliance.
• Experience working in a regulated environment and in accordance with GMP requirements – mandatory.
• Experience in the API industry – mandatory.
• Experience with sterile manufacturing and/or aseptic processes – an advantage.
• Managerial experience and/or experience leading processes – an advantage.
• High level of English proficiency, both written and spoken.
• Strong self-learning capabilities.
• Systems thinking combined with strong attention to detail.
• Ability to manage and drive multiple tasks and stakeholders simultaneously.
• Strong planning, organizational, and prioritization skills.
• Ability to work independently and collaboratively in a dynamic and changing environment.
• Excellent interpersonal skills, strong communication abilities, and a customer-oriented mindset.

Work Environment

• Projects are located in Southern Israel.
• The role includes ongoing interaction with clients and a wide range of professional stakeholders.
• This position is suitable for candidates seeking a role with meaningful professional impact, broad responsibility, and opportunities for professional growth in an advanced and dynamic environment.