Job Description
Job Purpose
The Head of Quality for Europe in the Over the Counter (OTC) division will provide strategic and tactical vision to ensure OTC Europe is compliant with all relevant regulatory requirements within the geo-graphic footprint of our business.
Major Accountabilities
1. Strong leadership of the OU / Country QA Heads
2. Accountability for Quality of all products released for sale in the Region
3. Develop and maintain our QA processes throughout the Region
4. Member of the Region Leadership Team (RLT) partnering with Region Head to strategize Quality as a key business competency
5. Key Interaction with all OTC Quality Heads, Responsible pharmacists, Qualified Persons in OTC country organisations, Pharma plants, and 3rd Party manufacturing
Key Performance Indicators
Leadership
• Provide leadership to quality team to ensure Quality of all regional OTC marketed products.
• Educate the Operating Units and strengthen Quality awareness by developing and implementing strategic plans.
• Ensure appropriate Quality staffing is in place to oversee 3rd Party activities.
• Lead effective training initiatives, support training and team development.
• Utilize active thinking to generate creative solutions to complex technical problems.
• Demonstrate ability to understand the business implications of his/her Quality decisions.
• Collaborate with Novartis divisional and cross functional associates on quality and compliance programs to optimize and harmonize related practises to assure elements of quality and process robustness
Management of Quality
• Evaluate the level of cGMP compliance for products manufactured, packaged, tested and released through key performance indicators and Quality performance indicators.
• Interprets cGMPs and evaluates Novartis procedures relative to local HA and industry standards.
• Lead company internal (GQO) and external (HA) audits through close partnership and pre-audit preparation with all affiliates and/or Manufacturing sites to ensure successful outcome. Evaluate and manage on the appropriateness and completeness of corrective actions plans until closure.
• Implement Quality action plans to minimize risks.
• Lead all quality activities for 3rd Party contract operations.
• Support technical services, product/process improvements.
• Investigate Quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Novartis and external Health Authority (HA) inspections.
• Liaise as appropriate with OTC BU and/or Regional Management, R&D, Novartis Corporate Security, OTC Novartis Emergency Management (NEM).
• Take leadership in management and decisions related to product tampering, NEM, product counterfeiting or Quality problems affecting batches.
• Provide guidance to 3rd party operations, manufacturing site(s), and OTC country organisations to minimize the compliance risk for Novartis products.
• Lead / Manage required documentation to meet the regulations, appropriate follow-up and implementation of preventative actions.
• Provide leadership, direction and support on all Quality/GMP topics raised by OTC country organisations and third party manufacturing sites.
• Lead the establishment of Novartis Quality Systems by continually improving, and harmonizing Quality systems.
Job Dimensions
9 Direct Reports
Desired Skills & Experience
Masters Degree in Chemistry, Pharmacy, Biology, or related Science
Excellent English communication & negotiation skills (oral and verbal). Knowledge of French, Spanish, and / or German a plus
12+ year’s relevant experience in a regulated Pharmaceutical industry including Quality Assur-ance, Quality Control, and/or R&D or Drug Regulatory Affairs.
Strong professional experience in cGMPs, Quality Systems, analytical chemistry, manufacturing processes, packaging processes. ICH requirements and current industry practice.
Experience in managing 3rd party facilities.
Excellent knowledge of computer systems; i.e. Microsoft Word, Excel, PowerPoint, & Visio.
Experience in working in an international and multidisciplinary environment.
Champions Novartis Shared Values; especially - Quality and customer focus, leadership, ability to take decisions in balancing risks taken and to propose solutions, results driven, communication and presentation skills, flexibility to re-organise own use of time to face emergencies in the organisation, excellent negotiation skills to achieve win-win situations, and strong organizational skills
Ability to motivate and energises team for improvement through effective interpersonal and leadership skills.
Willingness to travel (domestic and international); sometimes at short notice: travel time 30-50 %.
Apply Now - Resume or CV with Job Post Title
Email: jobs@aarenconsultants.in
