Manager, Quality Assurance
1. Ensure key system operational Quality activities are executed and managed appropriately:
· Execute and manage operational Commercial Quality activities necessary, including execution and management of departmental change controls, deviations/CAPAs temperature excursions, Oracle activities and departmental metrics.
· Provide operational support for Affiliate colleagues as deemed necessary and appropriate.
· Support implementation and maintenance of the Affiliates QMS.
· Support health authority inspection and audit readiness, cross-functional co-ordination and facilitate remediation activities.
· Coordinate departmental meetings and maintain minutes and action logs.
2. Execute operational activities required for Biogen International customers, distributors, and logistics partners
· In collaboration with the appropriate Regional Managers, make the necessary follow-ups internally and externally related to the revisions of the Distributor requirements prior to signatures.
· Perform annual customer qualification for Biogen International.
· Maintenance of wholesalers and logistics partners Quality Agreement templates and management of approved agreements.
· Tracking of distribution incidents
· Execution and management of change controls, deviations and CAPAs relating to Biogen International Partners.
3. Quality pipeline growth and continuous supply of product
· Ensure actions required for product launches are communicated, assigned, and completed appropriately and in line with launch readiness requirements.
· Ensure all quality activities relating to distribution are completed on target.
· Coordinate supply of standards to enable product testing in country.
· Execute appropriate change control activities to support supply with foreign presentation and make necessary hold releases
4. Support recall and manage distributed material product issues, including falsified medicinal product
· Assist recall coordinator to track action items and ensure activities and documentation are completed on target and in line with recall implementation as defined by recall committee.
· Execute associated TrackWise activities.
- 5-10 years in pharmaceutical, or similar, industry
- Knowledge of GMP and GDP regulations
- Previous experience in logistics/distribution areas an advantage
- Fluency in English
- Knowledge of distribution in pharma and biological medicines, medical devices, cold chain, and ambient products
- Thorough understanding of regulations on Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP)
- Knowledge of EU and Swiss regulations as they relate to GDP, PV, GLP and GMP requirements.
- Working knowledge in ISO Requirements / Certification Process, ASQ or other auditing certification.
- Knowledge on Supply Chain operations
- Knowledge of Distribution & Logistics and go-to-market regulations and requirements, as well as manufacturing needs and cold chain logistics
- Ability to drive decision making, and Change Management
- Leadership, ability to lead within the matrix
- Capacity to manage conflicts and solve problems
- Ability to communicate with impact in oral and written communication
- Interpersonal skills
- Agile to adapt and drive agility when priorities change
- Continuous improvement mindset
The role is responsible to manage and execute operational quality activities of the Commercial Quality team.
The role will also represent the team in various internal stakeholder and cross-functional forums including, but not limited to, Product launch readiness, Supply monitoring and maintenance and Asset quality sub-teams.
As needed, the role will act as backup for the key operational tasks required to be undertaken by the Commercial Quality team, specifically the Regional Managers and Central Warehouse teams.
The role is accountable for execution and management of the operational activities required to support the Commercial Quality team. Extensive interaction cross-functionally and divisionally is required (Regional Managers, Central Warehouse, Affiliates, Planning, External Quality, QPLs).