GxP Senior Consultant – Subject Matter Expert

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Pharmavise Corporation

WebsiteLinkedInAlle Stellen

11 - 50 Mitarbeiter

Gegründet 2013

🧬 Biotechnologie

💊 Pharmazie

⚕️ Krankenversicherung

Biotechnology • Pharmaceuticals • Healthcare Insurance

Die Pharmavise Corporation ist die erste Organisation für kontinuierliche Compliance (CCO), die sich der Aufrechterhaltung der höchsten Standards von Qualität und regulatorischer Compliance in der Life-Science-Industrie widmet. Zu unserer angesehenen Kundschaft zählen Fortune-500-Unternehmen aus den Bereichen Pharmazie, Medizintechnik und Biotechnologie. Wir bieten maßgeschneiderte Lösungen, die auf die spezifischen Compliance-Bedürfnisse unserer Kunden zugeschnitten sind, unterstützen sie von der Entwicklung bis zur Vermarktung und stellen sicher, dass sie ihre Compliance-Ziele übertreffen und gleichzeitig die Gesundheit und Sicherheit der Patienten verbessern.

Beschreibung

• Lead and deliver GxP-focused consulting engagements, serving as an SME across multiple functions such as Quality, Regulatory, Manufacturing, Engineering, and Clinical Operations. • Develop, review, and optimize Quality Management Systems (QMS) and regulatory frameworks aligned with applicable global standards (FDA, ISO, ICH, EU MDR, MHRA, Health Canada, etc.). • Provide expert guidance on compliance readiness, remediation, and responses to regulatory inspections (FDA 483s, Warning Letters, audit observations). • Design, execute, and oversee validation and qualification programs: Process validation Equipment qualification (IQ/OQ/PQ) Software/CSV (21 CFR Part 11) Cleaning and sterilization validation Computerized systems validation. • Support product development programs, ensuring adherence to design control, risk management, verification/validation, and DHF/technical documentation requirements. • Perform gap assessments, root cause investigations, and CAPA development to address quality and compliance risks. • Serve as an advisor to executive teams and technical leads on regulatory pathways, submission strategies, and lifecycle management. • Provide project leadership and mentoring to junior team members, ensuring structured execution and high-quality deliverables. • Prepare and deliver client-facing reports, technical documentation, strategic recommendations, and training. • Support change management, technology transfer, and scale-up initiatives for manufacturing and operations. • Travel to client sites as needed.

🎯 Anforderungen

• 15+ years of progressively responsible experience in GxP environments within pharma, biotech, medical devices, or life sciences manufacturing. • Recognized subject matter expertise in at least one of the following domains: Quality Assurance / Quality Systems Regulatory Affairs Validation & Engineering (Process, Equipment, Automation, CSV) Manufacturing Operations / Tech Transfer Clinical Operations & Compliance Risk Management (ISO 14971) Design Controls (21 CFR 820, ISO 13485) • Strong working knowledge of global GxP regulations and standards (FDA 21 CFR, EU MDR/IVDR, ISO 13485, ICH Q-series, GAMP 5, ISO 9001/62304/17025, etc.). • Proven ability to lead cross-functional projects and serve as a senior advisor for complex technical challenges. • Prior experience in consulting, advisory, or client-facing technical leadership roles. • Excellent communication, documentation, and presentation skills.

🏖️ Vorteile

• Equal Opportunity Employer