Primary Responsibilities and Accountabilities:
- Partner and compliance expert to the Global process owner (GPO) for the development and implementation of a comprehensive strategy for global, x-functional regulated GCP/GVP processes in terms of
- Global Process implementation strategy
- Global Process effectiveness and continuous improvement
- Acts as a conduit for their GPO between global PD functions as well as gRED, pRED, GPS. Supports alignment and consistency between functional and X-functional business processes and systems with the overall global regulated process/SOP in close collaboration with key business stakeholders (e.g. BPOs, FQRs)
- Proactively identifies needs for process standardization, regulatory compliance direction and areas for improvement
- Provide expertise in analysis based on data driven decision making and metrics review to assess, prioritize and select improvement activities, linking with the CMOO metrics team
- Raise awareness and understanding of the process requirements to the senior management of the function (LTs, FE heads) and cross functionally when applicable, and provide clarity on role & responsibilities between PDQ, the CMO office and other business partners.
- Support the associated Global process owner (GPO) by working with other stakeholders such as the PDQ CAPA team, the associated Functional Quality responsible, other PDQS and PDQ functions and the CMO Office to identify systemic process related issues/risks, training or process improvement needs from deviation trends, findings in audits & inspectionreports to drive corrective and preventative actions
- Leverage process excellence methodologies to drive continuous process improvement
- Act as a change agent by partnering with key stakeholders to drive quality culture and embed a continuous improvement mindset
- Actively contribute to best practices and continuous improvement within the process excellence community and related functions
- Accountable for establishing, maintaining and fostering strong relationships with key business partner and ensure that PDQ is providing efficient, effective, value added support to the function and cross functional when applicable.
- Representing PDQ on process related taskforces/working groups in collaboration with the GPO.
- Mentors and coaches junior staff in PDQS.
- Contributes to the PDQ Quality Services Team to set strategies and achieve the long-term goals & objectives for PDQ as a whole.
- Is knowledgeable of all services and activities provided by PDQ in order to provide partners with a comprehensive overview and effectively communicate how PDQ can meet their quality needs.
Who You Are
- MSc or equivalent in an appropriate scientific discipline.
- 10 years of experience in various aspects of the international pharmaceutical clinical development process (Phase I-IV).
- Extensive knowledge and significant hands-on experience of clinical development and pharmacovigilance processes, roles and responsibilities
- Expertise in the principles and practices of Quality Risk Management and/or GCP/GVP inspections or audits.
- Demonstrated knowledge of GCP, GVP and regulatory requirements, as well as analytical, organizational and planning skills. Knowledgeable in stakeholder management and influencing change
- Knowledge of all services and activities provided by PDQ, Change Management expertise.
Experience, Skills, Knowledge:
- Excellent knowledge of GCP, PV processes and regulatory requirements.
- Demonstrated Business process management expertise
- Systemic problem solver, implementing sustainable solutions to solve root cause of problems in a complex environment or potential conflict.
- Ability to analyze and simplify complex systems or processes into pragmatic solutions
- Superior communication skills to work effectively and credibly with senior leaders from across the Roche organization.
- Ability to build and maintain excellent relationships with key business partners.
- Demonstrated ability to influence and lead both with and without authority.
- Project management of projects with cross functional involvement and complex timelines preferably in a Quality environment.
- Ability to work effectively in an international multicultural matrix organization.
- Creates an environment that encourages and rewards teamwork and collaboration, both internally and externally
- Demonstrates ability to bring/inject global and multifunctional perspective and understands the impact of actions on the business.
- Fluency in written and spoken English.
Job ID: 2723625558