Director of Manufacturing and Quality Control

6 dagen geleden

Leiden, Zuid-Holland, Nederland Pharming Group Voltijd
About the Role

The Director of Manufacturing, Control & Support plays a crucial role in optimizing and coordinating commercial production and analytical processes. This position involves empowering cross-functional teams and external partners to drive continuous process improvements and ensure seamless operations.

Key Responsibilities

- Empower and coach the MCS team to take ownership of process improvements and operational efficiency, ensuring that production and quality control processes run smoothly at CMOs/CLOs.
- Oversee and optimize process workflows during commercial production, including re-validation, issue resolution (deviations/CAPAs), and support for audits, in collaboration with the cross-functional teams (R&D, CMC).
- Ensure efficient transfer activities for commercial product manufacturing and analytical testing to new CMOs/CLOs, fostering collaboration between stakeholders to maintain seamless operations.
- Trend and analyse process and analytical data for continuous improvement of commercial products, empowering the team to identify and implement improvements in collaboration with cross-functional partners.

Requirements

- Master's degree or Ph D in Chemical Engineering, (Bio)Pharmaceutical Sciences, Chemistry, or related field.
- Deep understanding of pharmaceutical manufacturing, validation, and lifecycle management, with a focus on process optimization, commercial production, and quality testing.
- Strong knowledge of regulatory guidelines (c GMPs, FDA, EMA) and the ability to align operational processes with these standards.
- Strong verbal and written communication skills in English (Dutch a plus) to effectively coach, collaborate, and support team empowerment.

What We Offer

- A highly competitive salary
- 8.33% holiday allowance (for NL)
- A minimum of 30 vacation days
- An excellent pension plan
- Commuting allowance

We truly value a healthy life-work balance with a lot of flexibility.

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