Reference Number: JO-2106-470733
Principal Quality Officer
Job Type: Contract
Cpl Life Sciences are actively recruiting for a Principal Quality Officerto provide expert support for the development and implementation of a Global Quality Management System (Processes, procedures) and Operations distribution model for commercial pharmaceutical distribution from Global manufacturing plants to the companys network locations. The position has the purpose of developing and maintain systems and Quality Operational decisions that support Transportation Quality Assurance compliance and product continuity of supply.
- Working within a cross functional team and individually, working to support the assessment of existing processes, design of new processes, writing and implementation of written procedures, embedding of new and advanced digital technologies within processes, vendor assurance and management activities, cross functional stakeholder collaboration, negotiation, training and education.
- The Principal Quality Officer will lead and support the management of Global IO TQA vendor management activities, logistics change controls, resolution of complex failure events and support continual process improvement.
- The Principal Quality Officer will have an advanced theoretical knowledge and practical implementation of the legislative and QMS requirements within the GDP Transportation and GMP Manufacturing space.
- The Principal Quality Officer will ensure competent authority enquiries, inspections, visits and internal Pfizer audits are appropriately supported and issues resolved in a timely and robust fashion.
- Ensure rapid escalation and communication to senior management of any serious deficiencies or risks associated with the QMS or related operational activities.
- Management of and continual improvement of assigned quality system elements to ensure full oversight, completion of associated responsibilities and tasks, provision and interrogation of metrics data and associated identified actions.
- Bachelors degree in a related scientific discipline with relevant experience (Preferably Biology / Chemistry/ Pharmacy/Life Sciences)
- Advanced practical experience in pharmaceutical transportation, digital technologies, vaccine manufacturing, and control measures
- Experience in Quality administered systems. Previous use of SAP and Trackwise QMS providing a significant advantage.
- Ability to apply technical knowledge and understanding to making appropriate and timely risk-based decisions.
- Able to demonstrate good planning and organization skills
- Attention to detail and accuracy able to follow verbal and written instruction (SOPs).
- Quality and process orientation and mindset
- Excellent system skills Word and Excel essential, experience with electronic documentation control systems advantageous.
- Excellent personal planning and organizational skills. Comfortable in working across EU and US time zone equally.
- Enthusiastic, positive individual driven to meet targets and standards
- High level of self- integrity and ethical conduct
Prior Experience Preferred:
Experience associated with operating within EU and US Transportation Supply Chains, Quality Standards and be considered equivalent to or have been trained and experienced as a Responsible or Qualified Person