Product Portfolio Manager
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.