Head of Quality Synthetic API Facility

at  AstraZeneca

As the Head of Quality for the API Facility at College Park, Dublin, you will lead a team responsible for the quality assurance oversight and control testing of Active Pharmaceutical Ingredients.
Whilst working with the API Leadership team in developing and deploying the operations strategy, you will also oversee the day-to-day operations of the quality team and related laboratory activities, ensuring compliance with regulatory requirements and company policies while driving continuous improvement initiatives.

Accountabilities

• Develop area-specific quality plans, managing delivery within a defined Quality Assurance framework for the site on the long-term (18 – 24 months).
• Act as an escalation point for complex issues within the site, managing issues through to resolution.
• Determine the talent, materials, equipment, and services required for long-term delivery targets; and ensure adequate resourcing / development of capabilities and capacities.
• Assess immediate and long-term risks to quality processes and workflows and propose and/or implement pre-emptive actions through engagement with cross functional teams and site leadership team.
• Drive transformation projects for implementation of technology overhaul, digital change strategies within the API facility and relevant QC laboratories.
• Direct future-focused skills development interventions through cross functional / regional and external partnerships to equip and adapt workforce to evolving technologies.
• Explore, identify, evaluation and leverage opportunities for technology / best practice adoption with the site.
• Manage overall relationships with the regulatory bodies, dealing with and resolving any issues raised.
• Identify risks and opportunities using appropriate risk management techniques balanced with compliance with quality principles and regulatory requirements.
• Deliver and monitor budgets including capital for own site area.
• Build, lead, and motivate quality team within site to achieve the stretch goals.
• Develop professional and leadership capabilities of quality professionals and managers through coaching, delegation and development plans.

Education, Qualifications, Skills and Experience

• Bachelor’s degree in relevant Science field and substantial relevant experience in pharmaceutical quality, manufacturing, or regulatory roles
• Experience in leading and managing a sizeable quality function and delivering improvements.
• Strong leader able to set direction and instil commitment to a quality culture.
• Proven track record of attracting and developing talent, building capability and driving performance in direct and matrixed leadership roles
• Experience working with regulatory / SOP / GxP requirements and driving compliance.
• Experience in project, change & budget management.
• Track record of delivering results by developing strategy based on business needs and driving performance, collaborating, and building trust across boundaries and building strong networks.
• Strategic thinking, influencing and communication skills, able to explain complex ideas in clear and compelling ways to multiple stakeholder groups.
• Knowledge of Lean leadership approaches and ability to simplify complexity.
• Post-graduate qualifications in Analytical Chemistry or Business Management
• Experience in leading transformational change programs across Quality Control networks.
• Experience in owning or leading Quality Assurance and Control site activities.
• Extensive experience in preparation, hosting, and response to regulatory inspections
• Experience with Business Process Management
• Change Management, Change Agent roles.
• Strong program and project management experience
• Laboratory business acumen and ability to generate robust business cases and impact analysis.
• Robust external network and industry current practice knowledge

Please refer the Job description for details