Products Portfolio Quality Manager
For our Quality team External Network we are currently recruiting a Product Portfolio Quality Manager. In this dynamic role you will be responsible for the Quality Governance over the portfolio of products and CMO's assigned. This role will be based in Rueil-Malmaison.
- 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 report
- Lead specific projects when required
- Scientific Degree with a professional qualification and QP status desirable
- Minimum of 10 years related pharmaceutical industry experience including experience in a cross functional leadership role with proven record of delivery
- Experience in CMOs management
- Thorough working knowledge of regulatory requirements impacting the pharmaceutical and medical device industrie
- Extensive knowledge of GMP, GD
- Experience in auditing in GMP/GDP/ISO environments
- Experience with 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.
Excellent renumeration package