This opportunity is available in Villa Guardia, Italy.
Responsible for leading the Quality Assurance (QA) team on the Villa Guardia (VG) site which oversees all VG related operations and development functions. Responsible in this context for direction/supervision of the QA aspects of biological APIs, commercial, IMP products, and development projects for all aspects of GMP. A member of the VG Quality team, based in VG with team members based in the VG site.
- Actively participate in the VG Quality Team with particular focus on enabling the QA team to efficiently achieve their business goals while being compliant with the required quality standards.
- Manage from the quality perspective relationships with customers and suppliers of raw materials, APIs, packaging components, drug products and service providers
- Develop & maintain appropriate Quality or Technical agreements with all GMP contractors.
- Prepare and/or review or approve quality metrics including Annual Product Quality Review.
- Act as a key Quality SME during regulatory inspection or customer audits.
- Participate in Recall/Mock Recall Committee meetings as appropriate.
- Manage a team of QA professionals in the following functions:
- QA GMP/GDP Compliance
- QA GMP Validation
- Work effectively with other colleagues in the VG Quality team, and particularly with the QC leader
- Support the GMP contractors’ qualification program including initial and ongoing qualification to ensure quality oversight.
- Carry out other Quality related duties as requested by the Site Head of Quality, including audits, provision of QA support to key company pre-and post-approval development activities (e.g. tech transfers, life cycle maintenance activities, integration activities, technical diligence activities).
- Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines.
- Work directly with other key Company departments to ensure compliance and productive working relationships.
- Work directly with other members of the Quality department, as required, to provide support in the management of other GxP activities.
- Integrate, contribute, and/or lead cross-functional project teams as required. Support project schedules as required.
- Foster a positive employee relations environment and a culture of continuous improvement and teamwork through the use of good and consistent management principles.
- Live the Jazz Pharmaceuticals values.
- Bachelor’s degree in chemistry, biology, pharmacy or a related discipline. An advanced degree in biopharmaceutical science desirable.
- Qualified to act as QP for the VG site.
- Significant experience (10+years) working in pharmaceutical industry
- Experience should be in the QA and/or manufacturing areas, including a minimum of 5 years in a leadership position within the pharmaceutical industry.
- Experienced with and good understanding of global regulatory agency requirements, associated guidance documents related to API manufacture, Pharmaceutical Quality Systems, GMP, GDP and IMP requirements.
- Experience participating in quality audits, including drug substance manufacturing and analytical testing sites.
- Experience in the following desirable:
- Finished product manufacturing, particularly sterile product manufacture and biotechnological processes
- Analytical method development or executing analytical methods
- Process validation and IT compliance
Required knowledge and Abilities:
- Ability to work independently with minimal direction
- Assertive, proven manager with a strong results orientation and sense of urgency.
- Ability to develop and manage a high performance team focused on accountability and meeting/exceeding expectations.
- Ability to lead, influence, and work effectively within a multi-functional environment and multi-disciplinary teams
- Highly organised, with strong work ethic, exceptional time management and prioritization skills.
- Critical thinking and evaluation of process problems.
- Excellent interpersonal and communication skills.
- Ability to travel globally if needed.
Key Competencies Required:
- Leading the QA Team: Develops/communicates a compelling vision and sense of purpose for the team; works collaboratively to formulate long-range and mid-term strategies; demonstrates courage in advancing new, innovative ideas; champions change initiatives to enhance organizational performance.
- Collaboration: Works with others and builds effective relationships to accomplish common goals and objectives. Shares information, ideas and solutions with others. Recognises when compromise is necessary while working towards consensus with a focus on outcomes which reflect the collective need.
- Influence and Impact: Develops effective influence strategies based on an understanding of the motivations and needs of others; effectively represents one’s own perspective and communicates in a manner that generates support and commitment for proposals/recommendations to enhance the organization’s performance.
- Integrity: Displays honesty, truthfulness, trustworthy, principled actions and leadership, business ethics and compliance. Demonstrates consistency between words and actions. Honest in communication and feedback. Honours commitments to others. Handles confidential and sensitive information appropriately.
- Pursuit of Excellence: Continually improves and adds value. Is committed to high quality and standards. Is proactive in addressing issues that might cause problems or processes needing improvement.
- Innovation: Approaches problems with curiosity and open-mindedness. Takes educated risks. Is willing to explore new ideas and methods. Is willing to embrace and lead change. Is passionate about quality.
Jazz Pharmaceuticals is an Equal Opportunity Employer.