Job Reference: J5633559
Updated On: 30/07/2020
Status: Open to Applications
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Role OverviewWe are currently looking for a Quality Director to join a leading Biopharmaceutical company based in the Wiltshire area. As the Quality Director you will lead all quality operations and work alongside the Managing Director advising on the best path of growth for the business and future commercialisation options within the bioprocess industry.
Key Duties and ResponsibilitiesYour duties as the Quality Director will be varied however the key duties and responsibilities are as follows:
1. Ensure GMP and quality system compliance of all products and relevant operations with UK, US and international pharmaceutical GMPs and form a close working relationship with the Managing Director, Company Secretary other Senior Executives and Non-Executives. In doing so you will oversee the internal GMP and quality system audit program for all products.
2. As a member of the Executive Team, the Quality Director will contribute fully to the development of company strategy across all areas of the business, challenging assumptions and decision-making as appropriate and providing Development analysis and guidance on all activities, plans, targets and business drivers.
3. Monitor the external FDA, MHRA and Japanese regulatory landscape to assure internal systems and controls are in line with current practices and approaches to compliance. In doing so you will grow and develop the business through the identification and exploitation of opportunities and by establishing strategic collaborations and interactions with third parties including public and private sector bodies.
4. Develop and sustain a high performing team of direct reports, with attention to development and succession planning. You will promote and uphold the highest standards of professionalism in order to create, maintain and enhance the reputation of our client amongst its customers and stakeholders both nationally and internationally.
Role RequirementsTo be successful in your application to this exciting opportunity as the Quality Director we are looking to identify the following on your profile and past history:
1. Relevant degree or doctorate in a Life Science discipline (i.e Biological Science / Bioprocessing / Pharmaceutical Management) with significant experience in a quality leadership position for a GMP compliant international Biopharmaceutical environment. While we will be open to any Pharma / Biotech environment, those with experience in larger molecules will take priority on application.
2. Proven industry experience leading a quality function which is regulated by both the MHRA and FDA where you have owned the entire inspection process, and have demonstrable experience of operational/strategic practice in organisation change to meet business requirements and ensure continuity of service; assembling business plans including to support and grow the business (i.e. IPO process, strategic alliances etc)
3. You will be able to demonstrate prior experience of operating as a commercially astute, articulate, technically strong, dynamic, insightful and influential leader with the ability to operate at both strategic and operational levels
Key Words: Director of Quality / MHRA / FDA / Quality Compliance / GMP / Quality Leadership / GMP Quality Assurance / Pharmaceutical Standard / Highly Regulated / Quality Professional
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