Website Asset Recruitment
Director Quality Assurance
To provide leadership and direction to drive manufacturing operations and suppliers towards higher quality products and processes in accordance with corporate strategy, cGMP, and regulatory compliance. This includes developing strategic business plans and the tactical actions and resources necessary to execute them. The Director will be responsible for managing operational budgets including leading continuous improvement initiatives in quality. This role is responsible for the day to day management of Quality Control, Microbiology, and Quality Assurance for the site.
Key Role Requirements
• Provides leadership in developing and directing quality assurance and improvement initiatives for all company and supplier products and ensures ongoing compliance with local, national, and international standards and legislation.
• Promotes and advocates quality achievement and performance improvement across the organization by integrating quality control tools into processes (e.g. Continuous Improvement) and supporting new product development.
• Perform gap/risk analysis between applicable and current regulatory standards; establish and implement a quality plan to bring the company into regulatory compliance.
• Accomplishes financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analysing variances; initiating corrective actions.
• Monitors QA systems and advises executive team on system performance; publishes statistics regarding performance against set goals and makes recommendations.
• Leads the preparation for Health Authority inspections and audits and provides support to their execution and follow-up. Ensures that corrective and preventive actions (CAPAs) are tracked and implemented as committed and ensures timely remediation of any issues related to CAPAs.
• Acts as the primary contact with regulatory agencies for all communication for the site.
• Leads by example and proactively communicates and collaborates with internal staff, colleagues, the union and external stakeholders to drive results.
• Achieves results through direct reports by communicating job expectations & company vision; establishing individual goals in line with corporate/departmental objectives, coaching, reviewing performance results; holding accountable; providing training and skill development opportunities for growth and improved performance.
• Responsible for ensuring that all product quality complaints are being adequately investigated, trended, & reported and collaborates with department to ensure full customer satisfaction.
• Responsible for final product release to customer.
• Acts as a liaison with customer auditors and ensures corrective actions are completed according to customer specifications.
• Participates as required in the investigations regarding batch discrepancies, non-conformances and out-of-specification events to evaluate impact on product quality and ensure corrective action and non-recurrence. Approves/rejects as required.
• Ten years’ relevant experience in a regulated Pharmaceutical industry including Quality Assurance, Quality Control, with 5 years in a leadership role
• Practical experience acting as Qualified Person releasing product into the Irish and European Markets
• BSc degree in science or related field
• Knowledge of Analytical Chemistry, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing and packaging processes
• Must possess apparent leadership qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally.
• MS degree or MBA as asset