QA Operations Associate Director East Coast, NJ/US

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium.

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happener’.

For the Galapagos organization in the US, we are looking for a QA Operations Associate Director East Coast, NJ/US

Scope of the role

The QA Operations Associate Director for the East Coast region is responsible for QA oversight of the central site in the US, including QA activities related to batch manufacturing release and kitting release. The scope of responsibilities includes SOP quality review and approval in compliance with GxP guidelines, and CAPA/deviation related to batch and kitting release review and approval, as well as the detailed responsibilities listed below:

Your role

QA Batch and Kitting Release Oversight locally in compliance with GxP Guidelines. This includes:

• Lead and oversee QA activities related to batch manufacturing.
• Review and approval of Manufacturing Batch Records
• Ensure the accuracy and completeness of documentation.
• Lead the Product Quality Review Board (PQRB): Establish and manage the PQRB as needed.
• Consult with site teams and internal teams on deviations and quality issues requiring joint review.
• Ensure compliance with all operational steps from kitting to release.

Decentralized Manufacturing Sites Oversight:

• Provide oversight for DMUs throughout the batch manufacturing process.
• Monitor and manage simultaneous activities across multiple manufacturing sites.
• Serve as the primary QA liaison with the decentralized manufacturing team.
• Facilitate communication and coordination among internal departments.

Risk, Deviation, and CAPA Related to QA Operations:

• Implement risk management strategies to identify, assess, and mitigate quality risks in ATMP QA processes and ensure Decentralized Manufacturing units (DMUs) comply with applicable regulations and guidelines (FDA, ICH).
• Provide oversight for QMS QA records (impact assessments, OOS, deviations, CAPAs, risk registers), ensuring accuracy, completeness, and traceability.
• Proactively identify, co-develop, and co-implement technically robust systems and process improvements in response to business requirements, technical changes, and regulatory requirements.

Support and lead improvement projects Related to Kitting or Batch release:

• Continuously improve processes and systems owned by QA and related supporting services.
• Support regulatory inspections and audits for QA activities, ensuring timely and appropriate responses to findings.
• Drive continuous improvement initiatives to enhance efficiency, reduce errors, and optimize processes within the quality system.
• Analyze quality data to identify trends and areas for improvement.
• Provide training on QA operation policies, procedures, and regulations.

This role reports to the Head of Cell Therapy Quality US and collaborates with DMU Operations; DMU Site Authorized Person; Director QC; Clinical Site Manager; Galapagos Qualified Person (QP); Director MSAT; Associate Director Clinical Development and the PI of the clinical sites.

This role has a direct and controlling impact on departmental results, with authority to decide and prioritize resources.

• You have a relevant bachelor’s degree.
• At least 8 years of experience in a role within a GMP environment with thorough working knowledge of cGMP QA processes: QA management and Good Manufacturing Practices.
• You enjoy working in a fast-paced work environment with minimal direction and have the ability to to adjust workload based on changing priorities.
• Result-driven and can-do mindset, without compromising quality and compliance.
• Excellent interpersonal skills to achieve goals via cross functional alignment with internal and external stakeholders. You motivate, persuade, and inspire peers, both internal and external, facilitating decision-making processes.
• Experience in a commercial GMP manufacturing setting is preferred.
• Experience in an ATMP manufacturing setting is preferred.
• You are able to travel for F2F interaction with DMU management and global stakeholders up to 50% of your time.
• Result-driven and can-do mindset, without compromising quality and compliance.
• You are an independent and resourceful thinker.
• Written and spoken fluency in English.
• Based in, or willing to relocate to, New Jersey (Princeton area) with frequent travel to central sites, DMUs, and educational requirements.
• Recognized as an expert and leader in the field, indicating a strong reputation and influence within the industry.
• Able to think about the broader impact of problems and anticipate the effects of solutions beyond the immediate area of focus.

What’s in it for you ?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead in pharmaceutical research and innovation.

We offer a competitive compensation package and a supportive work environment with strong focus on your health and well-being. Join us in our journey towards sustainability, as we strive to make a lasting impact on both the industry and the planet.

We are Galapagos: together we can make it happen…!