QA Strategy Lead, CMC Development & Tech Transfer

Pharming Group; Leiden; Hybrid; EUR 72,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

33 vacation days

Holiday allowance

Growth opportunities

Job summary

Pharming Group is seeking an experienced Quality Specialist Development to join Pharming Technologies B.V. as the dedicated QA Business Partner for a CMC Development Team, overseeing quality across development, tech transfer and commercialization to ensure EU/US GMP compliance.

You will collaborate with QA, CMC, Manufacturing, Regulatory Affairs, Supply Chain, and external partners, driving quality improvements, supplier management, and adherence to Pharming's standards in a fast-paced, global

Qualifications

• Bachelor's or Master's degree in Pharmacy, Biotechnology, (Bio)Chemistry, Biopharmaceutical Sciences, Engineering, or a related field.
• 6+ years of experience in pharmaceutical or biopharmaceutical environment, including Quality Assurance.
• Strong knowledge of EU and US GMP regulations and experience in development, validation, and/or manufacturing.
• Experience with audits, supplier management, and quality systems such as SAP, MasterControl, or similar platforms.

Responsibilities

• Provide strategic QA guidance to the CMC Development Team throughout development, technology transfer and commercialization activities.
• Support and review development, technology transfer, validation, and commercial manufacturing activities.
• Contribute to maintenance and improvement of the Quality Management System, including quality documentation and quality agreements.
• Perform supplier qualifications and audits, and assess quality and compliance risks across stakeholders.
• Advise project teams on GMP, quality, and compliance topics, acting as a trusted coach and expert.

Skills

Excellent communication skills

Proactive mindset

Ability to influence stakeholders

Regulatory knowledge: EU/US GMP

Education

Bachelor's or Master's degree in Pharmacy or related field

Tools

SAP

MasterControl

Job description

Pharming Group is seeking an experienced Quality Specialist Development to join Pharming Technologies B.V. as the dedicated QA Business Partner for a CMC Development Team, overseeing quality across development, tech transfer and commercialization to ensure EU/US GMP compliance.

You will collaborate with QA, CMC, Manufacturing, Regulatory Affairs, Supply Chain, and external partners, driving quality improvements, supplier management, and adherence to Pharming's standards in a fast-paced, global