Quality Manager
We are seeking a Quality Manager to lead and maintain our Global Quality Management System (QMS) across a diverse product portfolio. 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:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. Medicinal Products:
* Maintain Wholesale Licenses (WDA) by complying with GDP requirements, including Release of Medicines into UK and/or IE, managing authorised activities, accuracy and quality of records, initial and continuous training programs, recall operations, customer complaints, supplier and customer approval, subcontracted activities, self-inspections, delegated duties, and final disposition of returned, rejected, recalled, or falsified products.
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.