You will have global responsibility for Quality and Compliance of GxP/distribution activities performed by Roche affiliates and third parties contracted Pharma Global Technical Operations (PT), including quality oversight, inspection readiness, and strategic product quality management relating to commercial drug products as well as investigational medicinal products.
You should be able to empower, coach and inspire people and foster an environment where people feel included, contribute their value autonomously and challenge the status quo.
You will report directly to the Head of End-to-End External Quality Operations and be part of the External Quality Enabling Team which plays a key role in shaping and implementing GxP Partner and Distribution Management strategies that are aligned with the External Quality strategy and overall company vision.
Purpose:
Within this role, you will act as a strategic partner to key internal and external partners in support of a wide range of organizational priorities and business needs.
You will lead an empowered team of approximately 45 Chapter Members with a wide range of expertise to ensure \\xe2\\x80\\x9cRight to Operate\\xe2\\x80\\x9d at partners by implementing a customer-orientated lean end-to-end mindset.
Career Opportunities
Ensure GxP compliance in accordance with current applicable regulations (global as well as local), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.
Responsible for creating, maintaining and constantly improving the quality framework and business processes to enable product access, on time in full product supply and distribution of Roche products
Accountable for establishing and conducting Quality Governance within External Quality, e.g. Management Review of Quality (MRoQ), etc.
Develop & maintain/execute a roadmap to drive efficiency and effectiveness through continuous improvement and the establishment of harmonized/standardized systems, processes and tools.
Represent Roche/External Quality at strategic business reviews to drive consistent performance and higher customer satisfaction, both internally and externally.
Organization and Resources: Directly responsible for staffing, talent management, budgeting and resource allocation
Budgeting and Financial Performance: Accountable for overall budget and financial performance of the Distribution Chapter and jointly responsible for performance of the Area as a whole.
Demonstrate strong creative leadership skills according to the Visionary, Architect, Catalyst, Coach (VACC) model, collaboration and coaching skills with proven ability to build robust and empowered teams.
Qualifications and Experience
B.A. or B.S. degree in life sciences, Pharmacy or a related scientific discipline.
Profound experience in the Pharma/Biopharmaceutical industry with experience with working in Quality, Compliance, Regulatory and/or Validation and experience in leading teams in a matrix environment.
A fundamental solid understanding of quality assurance concepts including Good Manufacturing Practices (cGMP) and Good Distribution Practices (cGDP), GCP knowledge is a plus
Technical manufacturing understanding and experience in multiple technical platforms and product life cycles
Ability to establish and articulate a vision, set goals, develop and execute strategies, and track and measure results
Strong creative leadership skills according to the Visionary, Architect, Catalyst, Coach (VACC) model, collaboration and coaching skills with proven ability to build robust and empowered teams and solid communication skills and ability to influence at all levels
Travel up to 25% (domestic and international)
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\\xe2\\x80\\x99ve become one of the world\\xe2\\x80\\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. .
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.\\n \\n \\n \\n \\n \\n