Quality Officer

Sanofi; Reading; On-site; GBP 35,000 - 45,000; Full time

Job summary

A global biopharmaceutical company in Reading seeks a Quality Specialist to ensure regulatory compliance and support quality initiatives. The role requires a life science degree, 2 years in a quality environment, and strong communication skills. Enjoy a comprehensive rewards package while contributing to improving patient care across the NHS.

Benefits

Health and wellbeing benefits

Generous parental leave

Opportunities for career growth

Qualifications

• Familiarity with the pharmaceutical research and development process.
• Administratively well-organised and able to manage multiple priorities.
• Ability to work transversally in a matrix organization.

Responsibilities

• Develop understanding of the quality environment in UK and Ireland.
• Support management of Quality Document Systems.
• Prepare for Health Authority Inspections and Global Quality Audits.

Skills

Life science degree or equivalent

2 years' experience in a Quality environment

Strong written and oral communication skills

Familiarity with quality systems

Ability to adapt to changing priorities

Education

Life science degree

Tools

Commonly used software packages

Job description

About the job

Our Team: "At Sanofi, Quality is Everyone's Responsibility"

Our Quality team leads through collaboration, uniting Regulatory, Pharmacovigilance, Medical, and Supply Chain expertise to ensure excellence. We foster an environment of transparency and psychological safety where every voice matters and innovative ideas flourish. At the heart of every decision lies our unwavering commitment: putting patients first. Together, we don't just maintain quality standards – we elevate them.

Main responsibilities:

• Develop, and maintain, a comprehensive understanding of the quality environment, including data requirements, in the UK, Ireland and Europe, as required.
• Develop an understanding of the commercial environment in the UK and Ireland.
• Support the management of the Quality Document Systems to ensure compliant processes are in place to meet the requirements of the business.
• Supports the day-to-day operations of the Quality Events System to ensure that Quality Events are documented, processed, monitored, and completed with a focus on compliance. Quality Department Inbox is monitored for issues to be escalated.
• Supports the Self-assessment and External Audit process across the Business Units and support functions.
• Implement changes to local SOPs under their responsibility in-line with Global Document Updates. Ensure all Controlled Documents under their responsibility are compliant and maintained in a timely manner. Use SOPs where applicable. Highlight issues with SOP compliance.
• Support the preparation and running of Health Authority Inspections and Sanofi Global Quality Audits.
• Support the development of new initiatives within the department, MCO and company. Contribute to Team and Department Meetings and promote the work of the department within the Sanofi organisation. As necessary, perform tasks to ensure effective operation of the department and company.
• Support activities to ensure regulatory compliance, identifying and highlighting to line management issues where necessary.
• Support the activities of the Global Quality Team and assist the Country Quality Head in any other activities to ensure regulatory compliance.
• Maintenance of the facilitation of data entry to Local and Global Compliance database systems and ensure information is kept current for reports and trending.
• Support the GxP Training Programmes delivered by the Quality Department. Ensuring the mandatory training packages are updated when required.
• Support the Quality Third Party Management across all business units.
• Track and record the country PQR list and ensure PQR’s are completed within the allocated timelines under the assigned responsibility and in accordance with MAH requirements. Provide Country PQR data to global quality PQR group.

About you

Skills and Knowledge:

• Life science degree or equivalent and preferably 2 years’ experience in a Quality environment. Additional experience in the pharmaceutical industry or a related field would be an advantage.
• Awareness of the ABPI code of practice (UK) and/or IPHA Code (Ireland).
• Familiarity with quality systems within the pharmaceutical industry.
• Familiar with the pharmaceutical research and development process.
• Administratively well-organised, able to prioritise, have attention to detail, possess strong written and oral communication skills with the ability to clearly communicate in English (oral, written) and be able to manage multiple priorities.
• Training in quality requirements should continue, both externally through courses and meetings, and internally, to maintain an understanding of current quality requirements and issues.
• Ability to work transversally in a matrix organization & to foster a process simplification approach while meeting compliance requirements.
• Familiarity with commonly used software packages.
• Ability to adapt easy & quickly to changing situations and priorities.
• Ability to work transversally in a matrix organization.
• Ability to adapt to a combination of remote and office-based working as appropriate to deliver performance in the most efficient way.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
• Join us in shaping the future of respiratory care and making a difference in the lives of patients across the NHS.
• If you have a disability and require adjustments for the interview process, please email us at [e-mail]. We are dedicated to ensuring an inclusive and supportive experience for all applicants.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. We are proud to be a Disability Confident Employer, committed to offering interviews to candidates who request consideration under the Scheme and meet the minimum requirements for this role.