Job Description
Director of Quality Assurance role in Ireland or Letterkenny, with a focus on pharmaceutical quality assurance and regulatory compliance.
We are a leading healthcare company with a strong ecosystem of investment and innovation, constantly growing to support the healthcare needs of the future. Our business in Ireland is built on a dynamic and diverse team of over 2,000 talented individuals.
As a key member of our team, you will be responsible for upholding regulatory, compliance, and quality standards for the manufacturing, distribution, storage, and supply of pharmaceutical products. This role plays a critical part in ensuring compliance, quality, and operational excellence within our organization.
Key Responsibilities:
- Develop and implement quality assurance strategies, policies, and procedures to ensure compliance with regulatory requirements and industry standards.
- Support the development, implementation, and maintenance of quality systems to ensure adherence to regulatory requirements, industry standards, and best practices in pharmaceutical manufacturing.
- Support the execution of internal and external audits to assess compliance with regulatory requirements, identify areas for improvement, and implement corrective and preventive actions.
- Collaborate with cross-functional teams to support alignment on quality objectives, initiatives, and priorities.
- Implement quality metrics, key performance indicators, and dashboards to monitor the QMS's performance and drive continuous improvement.
- Support timely investigation and resolution of deviations, non-conformities, and customer complaints related to product quality, safety, or efficacy.
- Serve as a subject matter expert on quality assurance matters during regulatory inspections, customer audits, and internal reviews.
- Support the preparation for audits, including developing SOPs and ensuring readiness for regulatory inspections.
- Provide mentorship, training, and professional development opportunities for quality assurance and global trade team members.
Requirements:
- Relevant and current work experience in pharmaceutical industry Quality Assurance required, with a strong understanding of cGMP regulations, quality systems, and pharmaceutical manufacturing processes.
- In-depth knowledge of regulatory requirements and guidelines governing pharmaceutical quality assurance, including FDA regulations and ICH guidelines.
- Proven track record of building and managing high-performing teams of professionals.
- Strong leadership and communication skills, with the ability to effectively collaborate, influence, and educate stakeholders at all levels of the organization.
- Experience leading regulatory inspections and customer audits, with a track record of successful outcomes.
- Demonstrated ability to analyze data, identify trends, and implement proactive measures to mitigate risks and improve quality performance.
- Proficiency in quality management tools and methodologies, and quality management software systems.
About Us:
We are a leading healthcare company with a strong commitment to delivering high-quality healthcare and pharma solutions. Our mission is to help people live healthier lives and make the health system work better for everyone.
We believe in creating a healthier atmosphere by embracing diversity and promoting equal opportunities for all. We are an Equal Employment Opportunity employer and welcome applications from talented individuals who share our values.