The opportunity
The Director Commercial Quality US is responsible for the Commercial Quality activities in the United States, covering the responsibilities of the US Quality Systems of product distribution, warehousing, importation, team budget and associated resources, compliance activities including complaints and recall management, regulatory event reporting, drug shortage reporting, Health Authority, US FDA interactions and expectations, continuous improvement initiatives, strategic business plans impacting quality and compliance such as new product launch quality oversight and quality regulatory compliance of commercial engagements (internal and external).
The Director Commercial Quality US is the Quality Business Partner to the Commercial US Teams and is the coordinator for critical quality incidents impact drug supply continuity
Develops and sustains strategic programs establishing and reinforcing robust, compliant quality systems in CQ US and has an active membership and participation in US Commercial activities.
Ensures operational implementation of Quality Management System in compliance with GMP&GDP and Teva Corporate standards.
Ensures quality and compliance oversight of key performance metrics and management oversight quality councils and reviews and develops remediation plans on trends and signal risk
Promotes a Quality Culture within Commercial Quality units in the US
Defines a strategic plan and roadmap to ensure deployment and or consolidation of Commercial Quality Management System elements within the US Commercial units by including other GxP supporting functions such as Supply Chain, Regulatory Affairs, Medical, Pharmacovigilance
Represents US Commercial Quality in project deployments
Ensures that Local Commercial Quality Units have adequate GMP and GDP training as applicable
Initiates continuous improvement of processes and standards based on FDA Regulations and Expectations.
Ensures inspection readiness, continuously identify opportunistic areas for improvement
Ensures the coordination of critical incidents, Quality Alignment Meetings with Global Quality units and Quality Operations, development of communications to Health Authorities
Leadership and Management
Manages the Commercial Quality Teams in US that provide Quality and Compliance oversight of commercial operations.
Builds and maintains a high performing team, identify and develop talents.
Performs annual processes such as budgeting, performance reviews, mid-year reviews, year end reviews, performance management, etc.
Provides leadership, mentoring and professional guidance.
Defines annual objectives for the Region in alignment with Commercial Quality, US business priorities and growth strategies.
Your experience and qualifications
Master´s Degree in Pharmaceutical Sciences, Business, Healthcare or an equivalent combination of education and experience to the functional role
A minimum of 10 years of Quality/Compliance Leadership related experience in the Pharmaceutical (or related) industries in GxP environment preferred
Functional knowledge on Pharmaceutical Quality Assurance, US FDA and Regulatory Compliance
Demonstrate strong managerial skills, ability to lead managerial to high performance
Able to deliver results in complex, matrix, and multi-cultural environments
Able to motivate and lead teams through changes, to create collaborative atmosphere
Results driven; high execution skills
Ability to determine stakeholder’s needs and expectations and to act on them
Ability to adhere to determined timelines and manage complex processes.
Gathers and assesses relevant information, using abstract ideas to interpret it effectively
Communicates effectively, with authority and experience.
Open minded, out of the box thinking, creative thinking to create the most efficient solutions.
Demonstrates advanced judgment in determining whether Teva's practices are fully compliant and meet standards for quality excellence.
Enterprise thinker and strategic mindset
Adaptability, stress tolerant, organized, executes with the ability to be agile and flexible
Team Player with strong interpersonal skills and actively collaborates and cooperate with others
Establishes and maintains strong professional relationships based on integrity and trust at different levels within the organization.
