Quality Manager and RP/RPi

Healthcare Businesswomen’s Association; Greater London; On-site; GBP 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a QA Manager/RP to lead quality processes and ensure compliance with GxP activities. This role involves streamlining quality management, overseeing product import certifications, and fostering a culture of quality within the organization. Join a forward-thinking team dedicated to improving healthcare through sustainable practices and innovative solutions. If you have a passion for quality assurance and a desire to make a difference in the pharmaceutical industry, this opportunity is for you.

Benefits

Competitive Salary

Annual Bonus

Pension Scheme

Health Insurance

24 Days Annual Leave

Flexible Working Arrangements

Employee Recognition Scheme

Learning and Development Opportunities

Qualifications

• Proven experience in the pharmaceutical industry with GxP knowledge.
• Experience in developing quality systems and processes.

Responsibilities

• Leading local execution of quality systems and monitoring compliance.
• Investigating and resolving quality investigations to minimize impact.

Skills

GxP Knowledge

Problem-Solving Skills

Quality Systems Development

Technological Expertise

Regulatory Knowledge

Tools

Computer-Based Systems

Job description

Job Description Summary

Join us, the future is ours to shape!

Job Description

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 for:

• Providing leadership of compliant and efficient quality processes to support GxP activities at the Country Organisation, meeting internal and external stakeholder requirements.
• Streamlining and improving quality processes, facilitating quality management, and leading the development of a right-first-time, quality culture.
• Performing duties of the Responsible Person (RP) and overseeing activities to ensure compliance with guidelines on Good Distribution Practice (GDP).
• Performing the duties of a Responsible Person for Import (RPi) to ensure a system confirms that the required QP certification is in place for all products imported 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 local quality activities/systems, including metrics, quality review, and self-inspection, liaising with global quality system owners, and participating in expert networks or working with Centres of Excellence.
• Performing routine risk/impact evaluations related to product decisions or quality systems and participating in escalation situations.
• Ensuring local compliance with global standards/SOPs and maintaining relevant local SOPs.
• Communicating requirements or changes and acting as a content expert for audits and inspections.
• Investigating, managing, and actively resolving quality investigations such as deviations, complaints, and CAPA to minimize impact on product availability and sales.
• Gaining expert knowledge of IT platforms supporting quality systems and acting in multiple roles within those systems as applicable.
• Ensuring effective communication of quality matters within the country organization and with the Global QA organization, including issue escalation.
• Performing tasks related to quality compliance/governance, such as product launch evaluations, product divestments, quality oversight, regulatory updates, document development, metrics review, and acting as a single point of contact for e-compliance and data integrity.
• Working with the country organization’s business franchises/brands to provide direction and support for all quality/GMP matters, providing GxP education and training, and acting as a role model for Sandoz Values and Leadership Behaviours.
• Fulfilling the duties of the Responsible Person as defined by UK Health Authority (MHRA).
• Ensuring GDP operational activities are implemented, maintained, and continuously improved in accordance with internal guidance, external regulations, and best practices, staying updated with legislative changes.
• Performing the role of RPi to ensure QP certification for all imported products into the UK.

What you’ll bring to the role:

Essential Requirements:

• 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.
• Good problem-solving and evaluation skills.
• Experience in developing quality systems and/or processes.
• Proficiency with computer-based systems and applications.
• Relevant knowledge and experience in the distribution of medicinal products.
• Knowledge of products traded under the license and access to pharmaceutical advice when required.
• Demonstrated technical and GDP knowledge to fulfill RPi duties.

Benefits:

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. We aim to do more with investments in development, production, acquisitions, and partnerships to shape the future and help more patients access affordable, high-quality medicines sustainably.

Our culture is open, collaborative, driven by talented colleagues, offering agile and flexible careers that value diversity and support personal growth.

Join us!

Commitment to Diversity & Inclusion:

We are dedicated to building an inclusive work environment with diverse teams that reflect the patients and communities we serve.

Join our Sandoz Network:

If this role isn’t suitable but you wish to stay connected and learn about opportunities, join the Sandoz Talentpool.

#Sandoz

Skills Desired

Change Control, Continued Learning, Dealing With Ambiguity, Guideline, Product Release, Qa (Quality Assurance), Quality Management, Regulation, Risk Management, Self-Awareness, Technological Expertise