Quality Assurance Manager - Pharmaceutical Industry
Location: Edinburgh, United Kingdom
FPSG is working with a leading pharmaceutical company committed to delivering high-quality, life-saving medications to patients worldwide. We are currently seeking a dedicated and experienced Quality Assurance Manager to join our team in Oxford. This is an exciting opportunity to play a pivotal role in ensuring the safety, efficacy, and compliance of our pharmaceutical products.
Position Overview: As the Quality Assurance Manager, you will be responsible for overseeing all aspects of the quality management system to maintain regulatory compliance and uphold product quality standards. You will lead a team of QA professionals, implement quality processes, and drive continuous improvement initiatives across the organization.
Key Responsibilities:
- Develop and maintain the company's Quality Management System (QMS) in accordance with regulatory requirements (e.g., GMP, GDP, GLP).
- Lead and manage the QA team, providing guidance, training, and support to ensure effective execution of QA activities.
- Conduct internal audits, supplier audits, and risk assessments to identify areas of non-compliance and implement corrective and preventive actions (CAPAs).
- Review and approve documentation related to product manufacturing, testing, and release, including batch records, protocols, and reports.
- Collaborate with cross-functional teams to ensure timely resolution of quality issues and deviations.
- Lead regulatory inspections and customer audits, preparing the site and guiding staff through the audit process.
- Implement quality metrics and Key Performance Indicators (KPIs) to monitor and improve quality performance.
- Stay updated on current regulations, industry trends, and best practices in quality assurance and provide training to staff as needed.
Qualifications:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or related field. Advanced degree (MSc or PhD) is a plus.
- Minimum of 5 years of experience in quality assurance within the pharmaceutical industry, with at least 2 years in a managerial or leadership role.
- In-depth knowledge of GMP, GDP, GLP, and other relevant regulations and guidelines.
- Experience leading and managing QA teams, with a strong understanding of quality systems and processes.
- Proven track record of successful regulatory inspections and audits from regulatory authorities and customers.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
- Strong problem-solving skills, attention to detail, and ability to make sound decisions in a fast-paced environment.
- Certification in Quality Management (e.g., Certified Quality Auditor, Certified Quality Manager) is desirable.
We are Disability Confident and neurodiverse aware. If you have a disability, please tell us if there are any reasonable adjustments we can make to assist you in your application or with your recruitment process
