Quality Manager and Responsible Person (Ireland)

Job Description

This role is based in Ireland.

Your Key Responsibilities

Your responsibilities include, but not limited to:

• Leading local execution of quality systems including compliance to GxP requirements (requiring knowledge of regulations), global standards/SOP’s and local work practices, Responsibility for monitoring compliance of the quality activities/systems owned locally – including metrics, quality review and self-inspection. Liaise with global quality system owner and where appropriate participate in expert networks or work with Centres of Excellence.
• Perform routine risk/impact evaluations associated with product based decisions or the quality system and participate in escalation situations
• Ensure local compliance with global standards/SOP’s and maintain relevant local SOP’s. Communicate requirements and/or changes and act as content expert for audits and inspections using knowledge of associated system.
• Ensure efficient information flow and effective communication of all relevant quality matters within the country organisation, from the country to the Global QA organization and vice-versa including but not limited to issue escalation
• Develop and recommend changes for productivity and quality improvements. Lead in implementation of quality initiatives & continuous improvements including project planning, milestone delivery and communication within the team and cross functionally.
• Perform tasks related to quality compliance/governance depending on individual experience. This could involve product launch evaluations, product divestments, quality oversight, MAH responsibilities, regulatory updates, development of documents such as site master file or business continuity plan, metrics review, quarterly leadership presentations or acting as a single point of contact for e-compliance, data integrity, document management
• Work with the country organisation business franchises/brands to provide direction and support for all quality / GMP matters. Provide GxP education and training to others in the team and across the CO. Act as a role model for Sandoz Values and Leadership Behaviours, taking positive action to strengthen quality culture and awareness
• To personally fulfil the duties of the Responsible person defined by Irish Health Authority (HPRA). The responsibilities, knowledge, experience and duties of the responsible person as defined by the HPRA
• Ensure all GDP operational activities are maintained and continuously improved in accordance with all internal guidance and external regulations
• Maintain an awareness and understanding of the required legislations and Sandoz Quality System, implementing legislation and Sandoz Quality Standards and Quality Directive within GDP activities and supply chain processes.
• Oversee activities in the event of a product Recall and mock recall
• Understand the role of the professional bodies and organisations that regulate those supplying medicinal products to the public e.g. GPhC and role of home office in relation to handling of controlled drugs
• Ensure all GDP operational activities are implemented, maintained and continuously improved in accordance with all internal guidance, external regulations (MRA) and in line with best practice. Keep up to date with changes/ updates in legislation via Health Authority websites and/or newsletters, and any directive regulations or guidelines.
  
  

Essential Requirements

What you’ll bring to the role:

• Life science degree level or equivalent experience in the pharmaceutical industry, GxP knowledge
• >3 years Experience in the pharmaceutical industry operating as a Responsible Person
• Detailed knowledge of GMDP requirements relating to manufacturing, packaging, licensing, release and post-market responsibilities.
• Knowledge of process improvement techniques.
• Good working knowledge of problem solving and evaluation techniques.
• Development of quality systems and/or processes
• Coaching/training/facilitation
• Good level of skills in the use of computer based systems and applications
• Relevant knowledge and experience related to the distribution of medicinal products
• Knowledge of products traded under the license and access to pharmaceutical knowledge and advice when it is required
• Relevant knowledge and experience related to the distribution of medicinal products
  
  

You’ll Receive

Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!

The future is ours to shape!

Commitment To Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)

#Sandoz