Mantell Associates
Mantell Associates is currently partnered with a Cell Therapy organisation who are seeking a Director of Quality Systems to join their leadership team.
Director of Quality Systems – Responsibilities:
- Spearhead the continuous improvement of the design and development elements of the quality management system, ensuring that processes remain in compliance with company policies and other regulatory requirements as applicable
- Oversee staff performance and development goals, assign accountabilities, set objectives, establish priorities, and provide continuous feedback and recognition on performance
- Promote a culture of high performance and continuous improvement that values learning and a commitment to quality
- Lead quality engineering team responsible for providing design control guidance and support for new product introductions and significant design changes
- Develop and oversee the maintenance of SOPs for the documentation and execution of the company’s Design Control program
- Lead product development and product enhancement activities
- Oversee the development of hardware, software and assay requirements and specifications for new products
- Enable cross-departmental work to support the design, development, integration, transfer, production and after sales support of MSD software, instrumentation, associated test kits, consumables and reagents
Director of Quality Systems – Requirements:
- Bachelor’s degree in Biology, Chemistry, Biochemistry (or other Life Sciences) or Engineering
- Proven experience in a leadership quality role supporting design control activities for multiple or complex product types e.g. software, consumables, instruments
- Track record of successfully mentoring design and development teams with varying levels of knowledge and experience
- Strong business acumen, negotiation and mediation skills, as well as a demonstrated attention to detail and a focus on achieving quality outcomes
- Ability to build/foster relationships with internal and external stakeholders
- Experience working with FDA and/or ISO auditors preferred
- Strong leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.