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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 oversee activities to ensure compliance with Good Distribution Practice (GDP) guidelines.
* Perform duties of a Responsible Person for Import (RPi), ensuring a system confirms QP certification for all imported products into GB.
Your Key Responsibilities:
Your responsibilities include, but are not limited to:
* Leading local execution of quality systems including compliance with GxP requirements.
* Monitoring compliance of quality activities/systems locally, including metrics, reviews, and inspections. Liaising with global quality system owners and participating in expert networks or Centres of Excellence where appropriate.
* Conducting routine risk/impact evaluations related to product decisions or quality systems and participating in escalation processes.
* Maintaining compliance with global standards and SOPs, and updating local SOPs accordingly.
* Acting as a content expert during audits and inspections, communicating requirements and changes effectively.
* Managing quality investigations such as deviations, complaints, CAPA to minimize impact on product availability and sales.
* Gaining expertise in IT platforms supporting quality systems and performing multiple roles within those systems.
* Ensuring effective communication of quality matters within the country and with global QA, including issue escalation.
* Performing additional tasks related to quality compliance, governance, product launches, divestments, regulatory updates, documentation, and data integrity as per individual experience.
* Collaborating with business units to support GxP matters, providing training, and fostering a quality culture aligned with Sandoz values and leadership behaviors.
* Fulfilling the duties of the Responsible Person as defined by UK authorities (MHRA).
* Ensuring GDP activities are compliant with internal and external regulations and continuously improving processes.
* Performing the role of RPi, ensuring QP certification for imported products into the UK.
What you’ll bring to the role:
* Proven experience in the pharmaceutical industry with GxP knowledge, preferably in a matrix organization.
* Detailed knowledge of GMDP requirements related to manufacturing, packaging, licensing, release, and post-market responsibilities.
* Skills in problem-solving, evaluation techniques, and developing quality systems or processes.
* Proficiency with computer-based systems and applications.
* Knowledge and experience related to the distribution of medicinal products and pharmaceutical advice.
* Technical and GDP expertise necessary for the duties of RPi.
You’ll receive:
Competitive salary, annual bonus, pension scheme, health insurance, 24 days annual leave, flexible working, employee recognition, and development opportunities.
Why Sandoz?
As a leader in the sector, Sandoz provided over 900 million treatments in 2024 across 100+ countries. We aim to expand access to high-quality, low-cost medicines through investments and innovation, powered by an inclusive, collaborative culture that values diversity and personal growth.
Commitment to Diversity & Inclusion:
We strive to build an inclusive environment with diverse teams that reflect the communities we serve.
Join our Sandoz Network: To stay connected and learn about future opportunities, join the Sandoz Talentpool at Sandoz Talentpool (novartis.com).
Seniority level
* Associate
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing
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