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:
1. 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.
2. Ensure QMS procedures align with industry standards and regulations and other relevant local regulatory frameworks.
3. Maintain global quality policies, procedures, and standards, ensuring alignment across all regions and business functions.
Risk Management & Corrective Actions:
1. Lead risk assessments for quality and regulatory compliance across all product categories and guide teams in mitigating identified risks.
2. Oversee the development, implementation, and management of Corrective and Preventive Actions to address quality issues, deviations, and non-conformities across product lines.
3. Manage the root cause analysis process and ensure the execution of corrective actions to improve product quality and regulatory compliance.
Quality Control & Auditing:
1. Oversee internal and external audits, ensuring readiness for regulatory inspections and third-party assessments.
2. Lead or participate in audit teams to assess and improve product development, manufacturing, and distribution processes.
Product Lifecycle Management:
1. Ensure quality assurance and compliance throughout the product lifecycle, from concept to post-market surveillance.
2. Oversee change control processes to ensure proper lifecycle management and traceability of changes made to product formulations, designs, manufacturing processes, and packaging.
3. Ensure post-market surveillance activities (e.g., complaint handling, adverse event reporting) are performed in compliance with global regulations.
Documentation & Reporting:
1. Lead quality management reviews.
2. 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:
1. Develop and deliver QMS training programs to global teams, ensuring employees understand the requirements and responsibilities for maintaining high standards of quality and compliance.
2. Promote a culture of quality throughout the organization, fostering continuous improvement and ensuring all departments maintain a quality-first mindset.
Medicinal Products:
1. Maintain our Wholesale Licenses (WDA) by complying with GDP requirements of the role:
* RP/Rpi release of medicines into UK and/or IE.
* Ensuring that a quality management system is implemented and maintained.
* Focusing on the management of authorised activities and the accuracy and quality of records.
* Ensuring that initial and continuous training programs are implemented and maintained.
* Coordinating and promptly performing any recall operations for medicinal products.
* Ensuring that relevant customer complaints are dealt with effectively.
* Ensuring that suppliers and customers are approved.
* Approving any subcontracted activities which may impact on GDP.
* Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
* Keeping appropriate records of any delegated duties.
* Deciding on the final disposition of returned, rejected, recalled, or falsified products.
* Approving any returns to saleable stock.
* Ensuring that any additional requirements imposed on certain products by national law are adhered to.
Qualifications
1. Degree in Life Sciences, Engineering, Pharmacy, Quality Management, or a related field.
Specific Knowledge, Skills and Experience
1. 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.
2. Proven experience in maintaining global QMS systems and ensuring compliance with multiple regulatory frameworks.
3. Hands-on experience with inspections, audits, and submissions.
4. Eligibility to act as RP/RPi.
5. Hands-on experience managing PV/PMS.
6. Strong understanding of global regulatory requirements across multiple industries, including pharmaceuticals, medical devices, cosmetics, and dietary supplements.
7. Excellent communication, leadership, and interpersonal skills with the ability to influence cross-functional teams and drive a culture of quality.
8. Strong problem-solving and decision-making abilities with a focus on risk management, CAPA, and continuous improvement.
9. Proficient in quality management software, document control systems, and auditing tools.
10. Project management experience desirable, with the ability to manage multiple initiatives and meet deadlines.
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