Operations Director Corporate Quality Director Corporate Quality 84 Wood Lane, London, England,[...]

At Quell we seek to deliver truly innovative, life-changing therapies for our patients. Our vision as a company is to build a major global biopharmaceutical company bringing transformational and valued therapies for a range of autoimmune and inflammatory diseases, as well as preventing rejection in organ transplantation, based on modular engineered Tregs.

OUR COMPANY

Quell Therapeutics Ltd (“Quell”), the world leader in the development of engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, announced it has raised $156 million in an oversubscribed Series B financing. The financing round was co-led by Jeito Capital, Ridgeback Capital Investments, SV Health Investors and Fidelity Management & Research Company LLC with participation from founding investor Syncona. New investors include British Patient Capital through its Future Fund: Breakthrough program, Janus Henderson Investors, Monashee Investment Management, Point72 and funds managed by Tekla Capital Management LLC

THE ROLE

We are seeking a highly experienced and dynamic individual to join our team as the Director, Corporate Quality. This role will ensure that all quality systems and processes are designed, implemented, and continuously improved to meet regulatory standards (FDA, MHRA, EMA, etc.), support clinical development, and prepare for commercialization.

MAIN RESPONSIBILITIES

1) Establish quality requirements (GxP-compliant) to support product development, clinical trials, and technology transfers, ensuring compliance with MHRA, EMA, and other international standards.

2) Collaborate with R&D, Manufacturing Operations, clinical operations, and regulatory teams to integrate quality risk management and quality-by-design (QbD) principles / systems throughout the product development lifecycle.

3) Drive implementation of knowledge management and data integrity systems to support pre-clinical development, process development, and translational testing.

4) Ensure that the product’s quality attributes remain consistent across development batches and clinical trials.

5) Define Quality requirements for all process development work; liaising with MSAT/Regulatory/PAD, ensuring process developments are fit for GMP manufacturing and support the creation of a regulatory submissions.

6) Responsible for assuring Master Batch Records follow the IMPD, PSF, clinical protocol and all continuous improvements identified at GMP manufacturing sites.

7) Provide expert advice to GMP manufacturing sites, as needed, regarding process changes, investigations, and deviations.

9) Provide leadership in risk management and quality-by-design (QbD) principles for autologous cell therapies.

10) Coach, mentor and guide other members of the Quality team by providing technical expertise and guidance.

11) Provide quality oversight for engineering activities related to facilities, utilities, equipment, and computerized systems to ensure they meet regulatory standards and support the manufacturing of autologous cell therapies.

12) Provide in-depth technical knowledge across the whole of Quality to drive process improvements and changes.

13) Ensure alignment of Quality Systems objectives with broader Quality Assurance and company goals.

14) Act as a key member of the Quality leadership team, collaborating cross-functionally with Process Development, Manufacturing, Regulatory Affairs, and other teams to support quality initiatives.

15) Stay up-to-date with evolving regulatory guidance related to autologous cell therapy and ensure that the company’s processes are compliant with global requirements.

16) Other duties as assigned.

Technical Requirements and Experience

• The role requires deep expertise in Quality requirements for biotech or pharmaceutical products, with specific experience in cell and gene therapy manufacturing.
• Minimum 10+ years’ experience in quality assurance within the biologics or cell/gene therapy industries, with a minimum of 10 years in a leadership role.
• Expertise in GxP, FDA, MHRA, EMA regulations, and other international regulatory standards for biologics and cell therapies.
• Deep knowledge of quality risk management, QbD, and continuous improvement methodologies.
• Experience designing and implementing business processes to meet departmental and corporate needs.
• Proven ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities.
• Impact and influence – Develops and maintains effective relationships (both internal and external) to facilitate change.
• Able to sell strategies and agreements upward in the organization and into other lines of business and joint ventures.

Education

• Bachelor’s Degree in scientific or engineering discipline, or similar. Advanced degree a plus.

BENEFITS

• Holidays: 25 days per year
• Group Personal Pension: Auto enrolled at 6% employer contribution, 3% employee contribution
• Private Medical Insurance for your whole family

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