QMS Leader

Hyper Recruitment Solutions; Hounslow; On-site; GBP 70,000 - 120,000; Full time

Job summary

Hyper Recruitment Solutions is seeking a QMS Leader for a leading pharmaceutical company across the South West to South Central UK. The role focuses on overseeing the Quality Management System, ensuring cGMP compliance, and providing strategic leadership within the Quality department at the client's site.

You will lead regulatory filings, maintain DMFs, coordinate with regulators and suppliers, and drive continuous improvement of quality processes, risk management, and regulatory affairs

Qualifications

• Degree or higher in pharmaceutical sciences, chemistry, or physical sciences with extensive pharma experience in QMS and regulatory compliance in GMP.
• Proven leadership with experience managing teams and engaging stakeholders to build a robust quality culture.
• Experience with risk management, change management, and technical writing; strong interpersonal communication and proactive approach.

Responsibilities

• Lead management and continuous improvement of the QMS ensuring full cGMP compliance.
• Maintain regulatory filings including FDA and MHRA submissions and act as primary QMS/regulatory contact.
• Manage regulatory affairs activities such as DMFs and regulator/customer inquiries.
• Ensure site compliance with legal and GMP standards and monitor quality to meet regulatory and customer needs.
• Develop strategic plans for resources, validation and equipment to support growth.

Skills

Leadership

Risk management

Change management

Technical writing

Interpersonal communication

Stakeholder management

Team motivation

Education

Degree in pharmaceutical sciences

Chemistry

Physical sciences

Job description

We are currently looking for a QMS Leader to join a leading pharmaceutical company based in the South West to South Central of the UK. This exciting opportunity involves overseeing the Management System, ensuring compliance with regulatory standards, and providing strategic leadership within the Quality department. Based at our client's site, the role offers a chance to influence quality processes, maintain regulatory filings, and lead a dedicated team to deliver excellence in GMP practices.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the QMS Leader will be varied however the key duties and responsibilities are as follows:

• Lead the management and continuous improvement of the Quality Management System (QMS), ensuring full compliance with cGMP, regulatory, and company standards.
• Maintain and oversee all regulatory filings, including FDA and MHRA submissions, and serve as the primary contact for QMS and regulatory issues with suppliers and clients.
• Manage regulatory affairs activities such as preparing and maintaining DMFs and responding to inquiries from regulators and customers.
• Ensure site compliance with legal requirements, including Licences and GMP standards, and develop systems to monitor quality standards meeting both regulatory and customer expectations.
• As the Leader, you will develop strategic plans for resource allocation, validation, and equipment to support business growth.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the QMS Leader we are looking to identify the following on your profile and past history:

• A Degree or higher level in pharmaceutical sciences, chemistry, or physical sciences with extensive experience in the pharmaceutical industry, particularly in QMS and regulatory compliance across a GMP setting.
• Proven leadership skills, with experience managing teams and engaging stakeholders. We are looking for somebody who has help to set a positive and robust quality culture and able to confidently work with teams to ensure talent and skill is optimised.
• Experience of effective risk management, change management, and technical writing. As the Leader you will demonstrate excellent interpersonal communication skills, a proactive approach, and the ability to motivate teams.

WHAT’S IN IT FOR YOU?

• The opportunity to lead and shape quality standards within a global pharmaceutical organisation.
• A chance to develop your career in a role that combines strategic influence with operational management.
• Competitive benefits package and a supportive team environment committed to excellence.

Key Words:

• pharmaceutical
• QMS
• regulatory compliance
• GMP
• leadership
• regulatory filings
• risk management
• continuous improvement
• stakeholder management
• strategic planning