An exceptional opportunity has arisen for an Executive Director/ Quality Site Head (QSH) to lead and deliver on all aspects of Quality in this dynamic Biopharmaceutical site to include Biologics, Gene Therapies, among others (Drug Substance (DS), Drug Product (DP), Pkg., etc.).
The successful candidate will be a highly motivated, technically knowledgeable leader with proven abilities to lead the Quality Organisation to ensure the site reliably complies with current cGMP’s, has harmonized quality systems, quality assurance, quality control and compliance processes across Site which manufactures commercial and clinical products.
Reporting to the SVP, Chief Quality Officer, with responsibility for the mentoring and development of an exceptional team within the Quality Unit including Quality Control, Quality Assurance, Quality Validation, Quality Compliance and Site Quality System. This position sits on the Global Quality Leadership Team and the Cork Site Leadership Team.
You will drive excellence in Quality and productivity; effectively implement new quality technologies. You will also create an environment where people are engaged, grow, and thrive displaying a strong quality culture.
This position requires a broad range of knowledge and experience with biologic processes, drug development, analytical testing methods, lot disposition decisions, tech transfers, and understanding of the international regulatory landscape.
You will have proven experience developing a high performing team and providing leadership and guidance to the organisation, by providing strategic direction, setting clear expectations, goals and metrics, as a leader you will be accountable for all activities related to commercial production generated at the Cork Site.
Key Responsibilities
* Leads Quality and Compliance across the site, driving adherence to applicable cGMP regulations and company policies and procedures
* Accountable for Quality and Compliance decisions across the site, including product disposition decisions as per cGMP’s.
* Sets Quality and Compliance goals and objectives for sites; establishes metrics to continuously monitor site Quality performance; ensures goals and objectives are effectively met.
* Lead the Site Quality Review Team (SQRT) process to ensure site regulatory compliance and to identify opportunities for continuous improvement of products, processes, and the quality system itself.
* Provide technical direction and leadership to direct the quality review of product documentation, including deviations, investigations CAPAs (Corrective and Preventive Actions) and HA (Health Authorities) observations and represent Quality in site governance meetings
* Shape and influence Quality perspective and actions based on regulatory inspections and third-party audits.
* Oversee compliance audits and regulatory inspections by health authorities (e.g., FDA (Food and Drug Administration), European Medicines Evaluation Agency, HPRA (Health Products Regulatory Authority), PMDA (Pharmaceuticals and Medical Devices Agency), etc.), where apply ensuring internal site inspection readiness
* Provide expert interpretation and application of regulatory guidelines to ensure manufacturing operations, facilities, and documentation adhere to regulatory requirements, company procedures, and are consistent with industry standards.
* Sponsor Quality and Compliance harmonization, integration, and continuous improvement initiatives across the site.
* Partner and align with Quality Site Heads to drive Global Quality Strategic initiatives in alignment with strategic objectives.
* Interface with Senior Management to set policy on product quality and assure adherence to company and governmental standards.
Leadership Responsibilities:
* Embody compliance, quality, and continuous improvement mindset.
* Execute for Results: Maintain high standards of performance consistently collaborating with all stakeholders and following through on commitments.
* Convey a sense of urgency and drive issues to closure. Make timely decisions when a quick response is required and ensure evaluation of several options when needed.
* Work closely & collaboratively with Site Operations, Global Quality Functions, Regulatory, Tech. Dev. Clinical Operations, MSAT (Manufacturing Science and Technology) and Finance to achieve business goals.
* Possess excellent negotiating skills and enterprise mindset to achieve win-win outcomes in demanding situations (not related to quality decision).
* Build, develop and lead an engaged workforce and drive a high-performance culture that is innovative, agile, open to change, and constantly learning in a high growth and evolving industry
* Manage the selection, hiring and training of personnel on company and department policies, systems, and processes.
* Lead site Quality AOP, Forecast and Long-Range financial budgeting process and ensure adherence to budget
* Sponsor project teams and champion the effective deployment of new technologies, and systems to improve quality, optimize productivity, reduce cycle times, and deliver pipeline.
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