Schweiz, Basel-Stadt, Basel
Vereinigte Staaten, Kalifornien, South San Francisco
We Make Medicines.
Behind every product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at 11 locations around the world.
Are you passionate about Quality and looking for a meaningful role? Are you a leader who can build and share an inspiring vision, who can coach leaders and teams to be better, who is a catalyst for change and world class performance, and who knows how to create the architecture that enables their network to be the best in the industry?
This position offers a unique and exciting opportunity for a senior executive to enable, coach, lead and inspire people in the network across 8 sites with global reach in Asia, North and South America and Europe.
Reporting to the Head of Global Quality and Compliance, you will be a member of the PT Quality leadership team. By leading an agile organization with a mindset and culture that engages our employees to bring our medicines and services to more patients faster, you will be able to impact how as a company we ensure long term sustainability in manufacturing excellence. Your ability to inspire people to do their best work and be committed to continuing our cultural evolution, in addition to the ability to transparently share your own personal transformation, learnings and vision will enable a high performing organization where the value of manufacturing is optimized.
Your key duties and responsibilities will include:
- Build and lead a world-class drug product quality team to realize the company’s manufacturing strategy of a reliable, flexible, agile and integrated manufacturing network.
- Ensure cGMP compliance is maintained and continually enhanced globally across the Roche/Genentech Biologics & Small Molecules Drug Product sites.
- Responsible for the Quality of all Small Molecules & Biologics Drug Products.
- Accountable for product quality management activities at the network level to include product test and disposition, change management, investigation, and CAPA management, product field performance (complaint management) and product performance trending and reporting.
- Responsible for end-to-end Product Quality Risk management, as well as proactive management of Quality and Compliance related risks across Drug Product Manufacturing Unit (MU) sites. Ensure risks are managed to ensure our right to operate and quality supply to patients and properly identified and communicated.
- Ensuring proactive site cGMP inspection readiness programs that delivers successful Health Authority inspection results for facilities and laboratories in the Drug Product MU sites, ensures realization of Roche Quality and Compliance Requirements, continuous improvement and state of the art compliance status, as well as execution of corresponding strategic plans.
- Quality Business Partner to Head Manufacturing of Drug Product and member of the Drug Product leadership team working collaboratively with to ensure the Drug Product Manufacturing Unit goals are met and strategy and objectives are achieved.
- Responsible for ensuring GMP surveillance information and processes are deployed across network, which provide proactive GMP compliance and education.
- Development of Quality Culture and associated behaviors within the Drug Product network.
- Accountable for coaching and developing your team’s capability.
- Accountable for overall budget and financial performance of the Drug Product Quality network.
Who you are
- Servant and creative senior leader, motivated by our shared purpose, to generate value and impact beyond the sum of our individual contributions
- Ability to coach a team of high performing leaders, catalyzing their performance to be better than the individual contributions
- Minimum 15 years industry experience in biotech or Pharma industry with strong quality and compliance acumen, preferably with experience as Manufacturing Site Head/Quality Site Head manufacturing sites and the ability to lead large, complex global organizations; experience with Lean Production Systems and operational excellence
- Bachelor’s in Life Sciences, Business or Engineering, Master in Business or Life Science preferred
- Technical Experience in at least one of the following: Quality and/or Sterile Processing, Biotechnology production, Pharmaceutical dosage and packaging
- Able to build and lead diverse teams, develop talent and create a working culture that is transparent and values driven to accelerate the personal growth of employees
- Able to build trusted and relationships both internally and externally through authenticity, accountability, and respect for others
- Demonstrated global and cross-functional leadership through effective influencing, collaboration and cultural awareness both internally and externally
- Demonstrated innovative, forward-thinking, strategic agility to build a vision and plans for the quality organization
- Highly collaborative, able to engage, motivate and inspire cross-functional teams to deliver extraordinary results
- Skilled interpersonally with proven high-level influencing and negotiation skills
- Solution driven and courageous; empowering decision maker
- Engrained quality, safety and compliance mindset
- Strong financial business acumen
You are willing to travel domestically and internationally (20 - 35%).
If you still have questions, please check our FAQs and videos on careers.roche.ch/faq.