We are exclusively supporting a great Pharmaceutical business with recruiting for a Head of Quality / RPi, to join them as part of continued, and very exciting growth.
This is a very important hire for this business. The Head of Quality / RPi will play a key and very strategic role in shaping the company's quality culture/initiatives, whilst working alongside and as part of the senior leadership team to drive continued growth.
About the company you are joining:
A very reputable and values driven Pharmaceutical business that has seen tremendous results in recent years - they really are pushing the boat in terms of establishing themselves as a market leader within their respective field, and have continued to invest heavily in growing the business. Our client distributes a large range of Pharmaceutical products both domestically and internationally to a diverse customer base.
About the Head of Quality / RPi role:
As Head of Quality, you will act as Responsible Person (RP) and Responsible Person for import (RPi) in accordance with 2013/C 343/01 Good Distribution Practice of Medicinal Products for Human Use to ensure that the quality, safety, and traceability of medicinal products are maintained within the supply chain.
The Head of Quality will be named on the company's WDA(H), MS, CD and MIA (IMP) licences.
You will be responsible for leading the QA team to work closely and drive operational efficiencies whilst adhering to regulatory compliance, and the role will involve full operational and strategic responsibility for all Quality aspects to ensure the efficient and effective day to day running of the business.
Key Responsibilities:
Overall strategical responsibility for creating and implementing the company's Quality Strategy, with leadership responsibility of the Quality Assurance team. Assure the compliance of all activities with UK Good Distribution Practice (GDP) and Good Manufacturing practice (GMP) requirements and MHRA regulations. Driving a culture of continuous improvement in Quality, ensuring maintenance and improvement of the Quality Management System (QMS), ensuring it meets industry standards and regulatory requirements. Being MHRA audit ready; this will involve carrying out self-inspections, independent audits, identifying risks and proactively taking necessary preventative measures. Working closely with cross functional teams on new process projects, incident investigations, identification of root causes and process improvements. Managing MHRA regulatory inspections, client and supplier audits as well as risk management assessments. Liaising with regulatory authorities (MHRA, Home Office) on license application/variations, annual controlled drugs returns, DMRC reporting and product recalls while addressing any findings or non-conformances effectively.
Candidate Requirements:
Degree qualified in Scientific discipline, or equivalent - ideally you will be a GPhC Registered Pharmacist. Previously named on WDA(H) licence as an Responsible Person, and ideally be RPi qualified. A transformational leader and strong communicator, with a proven track record in coaching, mentoring and driving collective goals. Highly knowledgeable with technical expertise in all QMS related activities, offering significant experience in quality management within pharmaceutical distribution. Strong leadership capabilities and enjoys collaborating with cross-functional teams to drive positive change. A proven track record of managing regulatory MHRA inspections, client audits and self-inspections.
What is on offer?
A competitive basic salary. Annual bonus. Excellent benefits package including - Private Healthcare, Life Assurance & Pension. But, most importantly, the chance for you to make a really positive mark on a great business!
Our client is an equal opportunities employer and we encourage applicants from all backgrounds. For a full job description and more detailed overview of the opportunity, please apply or reach out directly to hear more. This is an exclusively managed recruiting process by Radar Recruitment. All applicants (including third party/unsolicited approaches) will be managed by Radar Recruitment.
Keywords:
Head of Quality, Responsible Person Import, RPi, Responsible Person, Quality Director, Head of QA, QA Director, Head of Compliance, Compliance Director
#J-18808-Ljbffr
This is a very important hire for this business. The Head of Quality / RPi will play a key and very strategic role in shaping the company's quality culture/initiatives, whilst working alongside and as part of the senior leadership team to drive continued growth.
About the company you are joining:
A very reputable and values driven Pharmaceutical business that has seen tremendous results in recent years - they really are pushing the boat in terms of establishing themselves as a market leader within their respective field, and have continued to invest heavily in growing the business. Our client distributes a large range of Pharmaceutical products both domestically and internationally to a diverse customer base.
About the Head of Quality / RPi role:
As Head of Quality, you will act as Responsible Person (RP) and Responsible Person for import (RPi) in accordance with 2013/C 343/01 Good Distribution Practice of Medicinal Products for Human Use to ensure that the quality, safety, and traceability of medicinal products are maintained within the supply chain.
The Head of Quality will be named on the company's WDA(H), MS, CD and MIA (IMP) licences.
You will be responsible for leading the QA team to work closely and drive operational efficiencies whilst adhering to regulatory compliance, and the role will involve full operational and strategic responsibility for all Quality aspects to ensure the efficient and effective day to day running of the business.
Key Responsibilities:
Overall strategical responsibility for creating and implementing the company's Quality Strategy, with leadership responsibility of the Quality Assurance team. Assure the compliance of all activities with UK Good Distribution Practice (GDP) and Good Manufacturing practice (GMP) requirements and MHRA regulations. Driving a culture of continuous improvement in Quality, ensuring maintenance and improvement of the Quality Management System (QMS), ensuring it meets industry standards and regulatory requirements. Being MHRA audit ready; this will involve carrying out self-inspections, independent audits, identifying risks and proactively taking necessary preventative measures. Working closely with cross functional teams on new process projects, incident investigations, identification of root causes and process improvements. Managing MHRA regulatory inspections, client and supplier audits as well as risk management assessments. Liaising with regulatory authorities (MHRA, Home Office) on license application/variations, annual controlled drugs returns, DMRC reporting and product recalls while addressing any findings or non-conformances effectively.
Candidate Requirements:
Degree qualified in Scientific discipline, or equivalent - ideally you will be a GPhC Registered Pharmacist. Previously named on WDA(H) licence as an Responsible Person, and ideally be RPi qualified. A transformational leader and strong communicator, with a proven track record in coaching, mentoring and driving collective goals. Highly knowledgeable with technical expertise in all QMS related activities, offering significant experience in quality management within pharmaceutical distribution. Strong leadership capabilities and enjoys collaborating with cross-functional teams to drive positive change. A proven track record of managing regulatory MHRA inspections, client audits and self-inspections.
What is on offer?
A competitive basic salary. Annual bonus. Excellent benefits package including - Private Healthcare, Life Assurance & Pension. But, most importantly, the chance for you to make a really positive mark on a great business!
Our client is an equal opportunities employer and we encourage applicants from all backgrounds. For a full job description and more detailed overview of the opportunity, please apply or reach out directly to hear more. This is an exclusively managed recruiting process by Radar Recruitment. All applicants (including third party/unsolicited approaches) will be managed by Radar Recruitment.
Keywords:
Head of Quality, Responsible Person Import, RPi, Responsible Person, Quality Director, Head of QA, QA Director, Head of Compliance, Compliance Director
#J-18808-Ljbffr
