Job Description
Director, Quality Assurance
Optum is seeking a highly skilled and experienced Director of Quality Assurance to join our team in Ireland. As a key member of our leadership team, you will be responsible for upholding regulatory, compliance, and quality standards for the manufacturing, distribution, storage, and supply of pharmaceutical products.
Key Responsibilities:
- Develop and implement quality assurance strategies, policies, and procedures to ensure compliance with regulatory requirements and industry standards.
- Support OPS Ireland leadership's quality system, including OPS Ireland's development, implementation, and maintenance of quality systems to ensure adherence to regulatory requirements, industry standards, and best practices in pharmaceutical manufacturing.
- Support OPS Ireland's quality assurance procedures, processes, and documentation that ensure the consistent production of safe, effective, and high-quality pharmaceutical products.
- Support the execution of internal and external audits to assess compliance with regulatory requirements, identify areas for improvement, and implement corrective and preventive actions (CAPAs) as needed.
- Collaborate with cross-functional teams to support alignment on quality objectives, initiatives, and priorities.
- Implement quality metrics, key performance indicators (KPIs), 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, ensuring successful outcomes and compliance with requirements.
- Support the preparation for audits, including developing SOPs, facilitating FTZ (Foreign Trade Zone) conversations, 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 e.g., FDA 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 (e.g., risk assessment, root cause analysis, FMEA) and quality management software systems.
Preferred Qualifications:
- Experience in overseeing global trade operations, including import/export compliance and logistics management.
- Excellent problem-solving skills, with the ability to lead root cause analysis investigations and implement corrective and preventive actions (CAPAs) effectively.
- Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects concurrently in a fast-paced environment.
About Optum:
Optum is a leading healthcare company that is committed to helping people live healthier lives and making the health system work better for everyone. We believe that everyone deserves the opportunity to live their healthiest life, regardless of their background or circumstances. Our mission is to make a positive impact on the lives of our customers, patients, and employees.
Equal Employment Opportunity:
Optum is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, civil status, family status, sexual orientation, disability, religion, age, race, and membership of the Traveller community, or any other characteristic protected by law.