Head of Quality Pharmaceutical

Head of Quality - GMP/pharmaceutical industry

Dublin, hybrid, permanent

A great new role for an experienced Quality Manager who enjoys managing people, is a certified RP and knows their way around the necessary compliances for the pharmaceutical and medical industry.

You will:

• Provide leadership to 3 Quality teams:

1. A quality team responsible for Quality Control of Distribution.
2. The Quality Assurance team (to meet the requirements for GDP & GMP
3. The Master Data team, for SAP ensuring adherence to all Quality guidelines.

• Be responsible for final disposition of returned products for whatever reason.
• Ensure Self-inspections conducted & recorded; CAPAs completed according to agreed timelines.
• Ensure all preparation for & actual external Audit program for Manufacturers, Suppliers & the external audit program of key 3rd Party Service providers are conducted successfully.
• Ensure that the Validation Master Plan including Temperature Validation (Mapping program) throughout for facilities & equipment is executed.
• Responsible for chair of Quality Mgt. Review & Quality KPIs & compliance with applicable EHS guidelines & regulations.

People Mgt. & Leadership:

• Provide leadership & direction to the Quality & Master Data teams team to ensure focus on Regulatory & Internal business commitments.
• Recruit, Train, Develop, motivate, & manage performance of the Quality & Master Data teams.
• Ensure succession plan for all key positions developed in line with the company's internal development programmes.

Business Needs & Leadership

• Determine & allocate resource needs in alignment with Operations, Commercial managers & where applicable, projects which require Quality input.
• Work closely with ops mgt. & commercial managers to support business objectives.
• Lead by living & promoting Core Values & Codes of Practice.
• Flexibility to work in an environment of multiple projects & varying workloads.

Key Exp. / Skills / Education

• a strong record of success in similar quality management role
• At least 5 years in a Quality Mgt. position in a pharma/GMP/ highly regulated manufacturing
• Formal Certification as Responsible Person essential
• Exp. Certified Auditor & proven exp. with the Competent Authority within an Inspection program.
• Good organisational & administrative skills
• Highly self-motivated; can influence others; able to work independently.
• Proactive, assertive with a sense of urgency to problem solving

Excellent Salary and Benefits package is available for the successful candidate.