Global Clinical Supply Chain Compliance Manager
Vor 6 Tagen
About the Role
We are seeking a highly skilled and experienced Global Clinical Supply Chain cGMP Compliance Manager to join our team at Roche. As a key member of our Business Operations Support (BOS) team, you will be responsible for maintaining and continuously improving the compliance of the Global Clinical Supply Chain organization with Roche PQS, GxP, and Health Authority requirements for IMP sourcing, manufacturing, and distribution.
Key Responsibilities
- Accountable for maintaining and continuously improving the compliance of the Global Clinical Supply Chain organization with Roche PQS, GxP, and Health Authority requirements for IMP sourcing, manufacturing, and distribution.
- Be an active member of the BOS Team and create a compliance vision and long-term roadmap for growth and development of all relevant PTDS areas.
- Architect an effective collaboration model within PTDS and relevant other functions, so that compliance-relevant governance, executional, and analysis processes are performed as required.
- Form an expertise center for all supply chain-relevant quality compliance topics and catalyze the understanding, adherence, and monitoring across PTDS.
- Provide team and 1:1 coaching to quality compliance experts in the various functions to strengthen knowledge and foster capability development.
- Anticipate relevant changes in our compliance requirements framework and assess the potential implications for PTDS and/or CMO's in terms of training requirements, process, and/or documentation changes, or system and data adjustments.
- Facilitate a yearly compliance goal-setting process, tracking, reporting, and making goals achievement & KPI progress transparent to the whole organization.
- Actively prepare and participate in quality in- or external audits and inspections and sponsor assigned quality compliance improvement projects and actively participate in cross-functional governance bodies.
- In the BOS team, act as deputy for Risk Management and Business Continuity Management.
Requirements
- Bachelor in Science, degree in Life Sciences or Business (Operations Management or Supply Chain Management), MBA or advanced degree.
- 7+ years experience in quality compliance topics, experience in supply chain compliance areas is an advantage.
- 5+ years experience in the Pharmaceutical industry including a solid understanding of supply chain management, clinical supply chain experience is an advantage.
- Fluency in English and German is a must.
- Approx. 10% international traveling might be required.
Competencies Required
- Effective leadership in matrix organizations Project manager role or Community Lead role), with shown ability of successfully leading cross-functional and cross-cultural teams.
- Problem-solving skills, with ability to anticipate problems, recommend solutions, and implement changes.
- Excellent change management and communication skills with the ability to positively influence colleagues, key decision makers, and customers.
- Demonstrated ability to establish and improve business processes.
- Self-starter mentality, with the ability to lead ad hoc teams, negotiate, and build consensus.
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