Want to make a global impact? We offer that.
Want to be part of a Great Place to Work in Ireland? We offer that too.
Welcome to AbbVie!
At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives around the world. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that's felt within healthcare and beyond.
We are now recruiting a high calibre Senior Manager & Qualified Person (QP) to join our diverse Eyecare Quality team in Westport, Co. Mayo. In this role you will be responsible for the integration and support of quality regulations: Ophthalmic drug, device and combination products Products for our Eyecare Business driving the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems. You will also develop and implement sound quality principles while minimizing disruptions to business, based on robust quality risk assessments.
Are you intrigued? Do you want to learn more?
A snapshot of your key responsibilities as Senior Manager & Qualified Person (QP), Eyecare Quality would be:
• Perform the disposition of drug, combination, and device products. Ensure batch disposition process is compliance with company practices and regulatory requirements.
• Support and endorse the non-conformance, change management and complaints programs at site
• Provide quality direction and guidance for projects related to processes, equipment, product and compliance
• Represent quality unit at business unit, project, and compliance meetings
• Provide input and approval of quality management system, procedures, validation, release and compliance documents
• Responsible for the management and oversight of a team, as applicable, including hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues.
• Ensuring adequate resources and appropriate training to effectively support and meet changing business and compliance needs.
• Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.
• Lead and oversee support activities related to product actions
• Assure key metrics are being monitored and met to ensure compliance and to drive continuous improvement including review of procedures and process to identify areas of opportunity.
• Partner with stakeholders across the enterprise to gain a better understanding of processes to determine best steps forward
• Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.
• Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
• Represent FQA in regional, global and cross functional teams, projects and programs, as appropriate.
To succeed in this role, you will have the following Education and Experience:
• Bachelor’s Degree in Chemistry, Pharmacy, Biology or other technical/scientific area required
• Qualification in Pharmaceutical Manufacturing Technology or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
• Eligible to act as Qualified Person to perform release of medicinal and investigational product
• 2-4 years’ experience in quality assurance, operations, regulatory or relevant experience. Some supervisory/management experience preferred
• Knowledge of aseptic processing, sterilization and packaging processes is desirable but not essential
• Knowledge and familiarity with product, process, and both internal and external customer requirements and regulations
• Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting pharmaceutical products, combination products and devices
• Strong influencing, motivational, interpersonal and relationship building skills at all levels.
• Excellent written and oral communication skills. Proficiency in English.
• Ability to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded.
• Strong decision making skills.
• Negotiation skills, effective collaboration and ability to anticipate needs and requirements.
So, does this all sound like the right role for you? Then join AbbVie!
As an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.
Travel: Yes, 5 % of the Time
Job Type: Experienced