Dir. Process Gov., Compliance & Risk (m/f/d)
- Holzkirchen (near Munich), Germany
- Closing date
- Mar 21, 2023
- Other, Legal/Regulatory Affairs, Manufacturing/QA/QC
- Position Type
- Full Time
- Organization Type
2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, its growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impact!This is one such role!
Director Process Governance Compliance & Risk is accountable for establishing, maintaining and optimizing the process governance, assessing pharmacovigilance system regulatory risks and driving global pharmacovigilance process enhancements to support key technology and business transformation efforts in close collaboration with Head Patient Safety Operations & Compliance. This includes responsibility for quality management, oversight and enforcement of processes and compliance reporting described in the pharmacovigilance system to meet Health Authority expectations
• Responsible to design and drive the governance of processes owned by Sandoz and strategic suppliers and assure conformity with Sandoz group policies and worldwide regulatory requirements.
• Chair compliance and risk committee (RCC) and process management committee (PMC)
• Assess the risk for the company regarding worldwide pharmacovigilance and device vigilance systems by overseeing the management and implementation of corrective and preventive actions (CAPAs).
• Develop and maintain efficient and uniform processes and global operating procedures (GOPs)/standard operating procedures (SOPs) to assure that worldwide regulatory requirements for marketed and development pharmaceutical products are met in consultation with relevant GOP/SOP governing body where applicable.
• Collaborate with other Sandoz global line functions, and countries to develop synergies, to drive performance and quality, to identify process improvement areas as well as development of respective process changes. and ensure compliance with the Health Authority expectations.
• Ensure implementation of GOPs/SOPs at global, regional, and local levels to support consistency in policies and processes in collaboration with Quality Assurance (QA). This includes assuring proper training and communication.
• Partner with Sandoz Group functions (including Clinical, Regulatory Affairs, Marketing, Communication) and QA, to ensure integrated high-quality processes, that meet regulatory requirements. This includes representing Sandoz patient safety on steering and/or compliance committees where relevant.
• Implement the foundational aspects of the Sandoz patient safety quality manual to have a sustainable quality management system in place.
• Oversee Pharmacovigilance System Master File (PSMF) metrics ensuring that Sandoz group is compliant with worldwide regulations and company policies & procedures are followed.
• Set strategy and drive initiatives within Sandoz patient safety and with Global line functions from all Sandoz Divisions to standardize PSMF metrics.
• Monitor quality of safety information and compliance for all relevant processes through tracking of key performance indicators
• Drive training excellence and training compliance and ensure process-related change management and communications strategies are in place.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
• Life Sciences/ Pharmacy/ Medical Sciences or equivalent degree
• Fluent English (oral and written). Knowledge of other languages are desirable.
• ≥ Ten years of experience in drug development, including clinical safety, pharmacovigilance, and closely related areas of development.
• ≥ Seven years of global people management and development experience required.
• Sound knowledge of global safety and pharmacovigilance regulations worldwide
• Demonstrated success in resource planning and management.
• Proven ability to work and handle multiple tasks independently and effectively
• Ability to lead and deliver cross divisional initiatives.
• Excellent negotiation, conflict resolution, decision making, problem solving, communication (written and verbal) and presentation skills.
• Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure.
• Excellent planning, organizational and computer skills
At Novartis, we are reimagining medicine.
Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible.
Novartis has one of the industry’s most competitive pipelines. Many of these projects, which include new molecular entities as well as additional indications and different formulations for marketed products, are for medicines that could significantly advance treatment standards for patients worldwide.
We have entered an exciting era in health and biomedical innovation. Powered by our incredible colleagues, supported by our flexible-hybrid working model, new AI powered learning, personal growth and career platform and a refreshed commitment to diversity, equity & inclusion, we are well-poised to help lead this transformative moment for our industry and for ourselves. Join Us!
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