Stability and Qos Leader
3 months ago
Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.
Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.
**Research & Development**:
**About the role**:
- Want a role with real-world impact? As a
- **Stability and QOS Leader **at Reckitt, you’ll have the freedom to support the development of products that touch millions of lives. Worldwide.**Stability and QOS Leader**
**Kingston upon Hull, East Yorkshire**
**Competitive Salary & excellent benefits package - Hybrid working, 25 Days Annual Leave, 10% Pension Contribution, Bonus, Private Healthcare**
- As the Stability Leader, this role is accountable for the management of all aspects of the stability facility and stability processes across the site, and as the Quality Overall Summary (QOS) Leader, it also holds responsibility for ensuring that Module 3 of the Electronic Common Technical Document (eCTD) / ASEAN Common Technical Document (ACTD) are approved within specified deadlines.**Your responsibilities**:
Key aspects of the role are to:
- Be accountable for the management of the Health R&D stability facility.- Be recognised internally as the Local and Global Reckitt Stability Subject Matter Expert (SME) for all of Health R&D, providing local and global consultation in this role and running stability forums both locally and globally.
- Ownership of end-to-end stability processes and procedures.
- Maintain adherence to Regulatory, cGMP compliance and Health and Safety guidelines within the stability and QOS function.
- Manage third party contracts related to the stability facility.
- Actively enhance KPI outcomes through targeted, ongoing improvement initiatives.
- Maintain audit readiness within the stability facility, fronting audits as required in the SME role.
- Develop, maintain and deliver stability training to cross functional teams.
- Maintain business continuity within Health R&D for stability storage and QOS approval.
- Escalate and manage risks and issues as appropriate.
- Line management of the Stability Engineer and QOS & Compliance Officers.
- Ensuring that all members of the team are suitably trained to perform their roles.
**The experience we're looking for**:
- Proven experience in the pharmaceutical industry, with a particular focus on managing and conducting stability studies.
- Knowledge and understanding of regulatory requirements for stability including ICH as well as experience of fronting regulatory inspections
- Existing credentials to support Global Reckitt Stability Expert status.
- Good understanding of cGMP and Health and safety legislation.
- Line management experience.
- Quality Overall Summary (QOS) author or the ability to train to become a QOS author.
- Agile and capable to deal with a wide range of stakeholders and requirements.
- Effective influencing and communication with a broad understanding of related functions and business units on site.
- Results oriented, proactive, resilient and self-motivated.
- Excellent communication skills both written and verbal.
- Evidence of successful KPI management.
- Good motivational and interpersonal skills
**The skills for success**:
Clear communication, excellent stakeholder management, results orientated, inspirational, entrepreneurial, self motivated
**What we offer**:
With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.
We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.
**Equality**:
At Reckitt, we recognise that in real life, great people don’t always ‘tick all the boxes’. That’s why we hire for potential as well as experience. Even if you don’t meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. Come and join a team whose purpose is to protect, heal and nurture in the relentless pursuit of a cleaner and healthier world.
All qualified applicants to Reckitt will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family
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