Product Portfolio Manager
This role can be based in Harefield, Rueil or Amsterdam.
This role is responsible for providing quality governance over the portfolio of product and CMO's assigned.
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
- Ensure Norgine Quality standards applied to sub-contracted or licensed-in products through management of Partners
- Works alongside the operation coordinator to ensure product supply, quality and regulatory compliance
- 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 report
- Lead specific projects when required.
- Scientific Degree with a professional qualification
- Minimum of 7 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 industries
- Extensive knowledge of GMP, GDP
- 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.