Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!
The QA Manager/RP will be responsible to:
- Provide leadership of compliant and efficient quality processes to support GxP activities at the Country Organisation meeting internal and external stakeholder requirements.
- Streamline and improve quality processes, facilitate quality management and lead the development of a right first time, quality culture.
- Perform duties of the Responsible Person (RP) and to oversee activities to ensure that the guidelines on Good Distribution Practice (GDP) are complied with
- Perform the duties of a Responsible Person for Import (RPi) ensuring a system to confirm that the required QP certification is in place for all products imported into GB
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 systems
- Investigate, manage and actively resolve quality investigations as needed e.g. deviations, complaints, CAPA at the country organisation (where necessary in conjunction with nominated third parties) to minimise impact on product availability and sales
- Gain expert knowledge of IT platforms/applications supporting quality systems and be able to act in multiple roles within that system as applicable
- 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
- 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 UK Health Authority (MHRA).
- 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
- Perform the role of the RPI ensuring a system is in place to confirm that the required (from a country on the list) QP certification is in place for all products imported into UK.
What you’ll bring to the role:
Essential Requirements:
- Proven Experience in the pharmaceutical industry, GxP knowledge preferably in a matrix organisation.
- Detailed knowledge of GMDP requirements relating to manufacturing, packaging, licensing, release and post-market responsibilities.
- Good working knowledge of problem solving and evaluation techniques.
- Development of quality systems and/or processes
- 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
- Demonstrated technical and GDP knowledge and experience to fulfil duties of RPi
You’ll receive:
Competitive salary, Annual bonus, Pension 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, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, 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 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 supported!
Join us!
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)
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