Products Portfolio Quality Manager - FTC 12-Months
Norgine, United Kingdom
Job Description
ABOUT THE JOB
Want a 3D Career? Join Norgine.
At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.
We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.
Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.
In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.
Because at Norgine, we transform lives with innovative healthcare solutions.
We have an exciting 12-month fixed-term contract for a Products Portfolio Quality Manager to join Norgine. The person holding this position will report to Senior Products Portfolio Quality Manager and be a member of the External Network Quality team.
The core responsibility of the of the Products Portfolio Quality Manager is to be responsible for the monitoring of GMP compliance in all Norgine external contractors and suppliers.
If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.
KEY RESPONSIBILITIES amp; ACCOUNTABILITIES
- To provide Quality Governance over the portfolio of product and CMO’s assigned
- Ensure Norgine Quality standards applied to sub-contracted or licensed-in products through management of Partners.
- Ensure monitoring and review of partners quality performance
- Maintain CMO compliance through review of activity and output from audits.
- Identify and agree on improvement actions together with the partners
- Create, negotiate and maintain Quality Agreements with partners.
- Review, evaluate, and contribute to investigation into OOS or major deviations communicated by the partners and follow-up on corrective actions associated.
- Assess any change control related to the products portfolio managed
- Ensure change control request made by the partners are evaluated internally and follow-up on implementation plan when change owner
- Review and evaluate answers to complaints received from our partners and follow-up on actions agreed.
- Review and approve the product quality review provided by the partners
- Prepare the product quality review when Norgine is responsible
- Review and analyse the trend associated to stability results communicated by our partners
- Review and approve protocol and validation reports
- Support EN projects when required.
- Provide quality support to the EN organisation
SKILLS amp; KNOWLEDGE
- Scientific Degree with a professional qualification
- Minimum of 5 years related pharmaceutical industry experience including experience in a cross functional role with proven record of delivery
- Experience in CMOs management
- Thorough working knowledge of regulatory requirements impacting the pharmaceutical and medical device industries
- Extensive knowledge of GMP, GDP
- Experience in auditing in GMP/GDP/ISO environments
- Experience with supporting Regulatory and ISO inspections
- Excellent influencing skills and ability to establish effective working relationships with personnel at Norgine.
- Excellent verbal and written communication skills ability to present effectively to groups
This role can be based from any of the Norgine sites in the UK, France, or Amsterdam.
Benefits vary between locations.
Sound good? Find out more about the career you’ll have with Norgine, then apply here.