Quality Manager

We are currently recruiting for a Quality Manager to join our Quality and Regulatory Affairs team! This is a remote role and can be based in either the UK or Ireland.

This role will lead and maintain our Global Quality Management System (QMS) across a diverse product portfolio that includes medicines, medical devices, dietary supplements, cosmetics, and US over the counter (OTC) products. This role requires a strategic and hands-on leader who can ensure compliance with global regulatory requirements, drive quality improvements, and ensure the safety and efficacy of products in multiple markets.

Key Responsibilities

Global QMS Maintenance & Compliance:

·       Lead the design, implementation, and continuous improvement of the Global Quality Management System (QMS) to ensure compliance with regulatory requirements for medicines, medical devices, supplements, cosmetics, and US OTC products.

·       Ensure QMS procedures align with industry standards and regulations and other relevant local regulatory frameworks.

·       Maintain global quality policies, procedures, and standards, ensuring alignment across all regions and business functions.

Risk Management & Corrective Actions:

·       Lead risk assessments for quality and regulatory compliance across all product categories and guide teams in mitigating identified risks.

·       Oversee the development, implementation, and management of Corrective and Preventive Actions to address quality issues, deviations, and non-conformities across product lines.

·       Manage the root cause analysis process and ensure the execution of corrective actions to improve product quality and regulatory compliance.

Quality Control & Auditing:

·       Oversee internal and external audits, ensuring readiness for regulatory inspections and third-party assessments.

·       Lead or participate in audit teams to assess and improve product development, manufacturing, and distribution processes.

Product Lifecycle Management:

·       Ensure quality assurance and compliance throughout the product lifecycle, from concept to post-market surveillance.

·       Oversee change control processes to ensure proper lifecycle management and traceability of changes made to product formulations, designs, manufacturing processes, and packaging.

·       Ensure post-market surveillance activities (e.g., complaint handling, adverse event reporting) are performed in compliance with global regulations.

Documentation & Reporting:

·       Lead quality management reviews

·       Ensure that all quality documentation is accurate, complete, and compliant with global regulations, and manage the retention and archiving of these records.

Training & Quality Culture:

·       Develop and deliver QMS training programs to global teams, ensuring employees understand the requirements and responsibilities for maintaining high standards of quality and compliance.

·       Promote a culture of quality throughout the organization, fostering continuous improvement and ensuring all departments maintain a quality-first mindset.

Medicinal products:

·       Maintaining our Wholesale Licenses (WDA) by complying with GDP requirements of the role:

o   RP/Rpi release of medicines into UK and/or IE.

o   Ensuring that a quality management system is implemented and maintained.

o   Focusing on the management of authorised activities and the accuracy and quality of records.

o   Ensuring that initial and continuous training programs are implemented and maintained.

o   Coordinating and promptly performing any recall operations for medicinal products.

o   Ensuring that relevant customer complaints are dealt with effectively.

o   Ensuring that suppliers and customers are approved.

o   Approving any subcontracted activities which may impact on GDP.

o   Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.

o   Keeping appropriate records of any delegated duties.

o   Deciding on the final disposition of returned, rejected, recalled, or falsified products.

o   Approving any returns to saleable stock.

o   Ensuring that any additional requirements imposed on certain products by national law are adhered to

Qualifications

• Degree in Life Sciences, Engineering, Pharmacy, Quality Management, or a related field.

Specific Knowledge, Skills and Experience

• At least 10 years of experience in quality management, with a strong background in managing QMS for regulated products, including medicines, medical devices, dietary supplements, cosmetics, and OTC.
• Proven experience in maintaining global QMS systems and ensuring compliance with multiple regulatory frameworks
• Hands-on experience with inspections, audits, and submissions
• Eligibility to act as RP/RPi
• Hands-on experience managing PV/PMS

• Strong understanding of global regulatory requirements across multiple industries, including pharmaceuticals, medical devices, cosmetics, and dietary supplements.
• Excellent communication, leadership, and interpersonal skills with the ability to influence cross-functional teams and drive a culture of quality.
• Strong problem-solving and decision-making abilities with a focus on risk management, CAPA, and continuous improvement.
• Proficient in quality management software, document control systems, and auditing tools.
• Project management experience desirable, with the ability to manage multiple initiatives and meet deadlines.