Global Clinical Supply Chain cGMP Compliance Manager
vor 6 Monaten
The Position
Department : Business Operations Support (PTDS-R)
Location : Kaiseraugst (CH)
The Global Clinical Supply Chain (GCSC) organization’s objective is to cost-effectively ensure the right product is in the right place at the right time every time, such that no patient will go without treatment and no clinical trial will be delayed.
The global Business Operations Support (BOS) team, with members based in Kaiseraugst (CH), South San Francisco (US) and Mississauga (CA), is an enabling team and supports all clinical supply chain functions with Strategy, Business Excellence, Business Analytics and Learning & Engagement expertise. BOS’s key areas include annual strategy review, Business Project and Portfolio Management, Goals/OBP definition, Risk Management, Business Process Management, Master Data, Analytics & Reporting, Resources & PVC planning, Training, Communication and LEAN (LPS).
The newly created cGMP Compliance Manager role will extend BOS’ fields ofexpertise predominantly for Quality compliance and act as sparring partner for other compliance related areas. In this global role, you will serve as a central compliance center of excellence and closely work with all GCSC functions (Plan, Source, Make, Deliver, Enable). In addition, close collaboration with compliance experts in Pharma Technical Operations Development (PTD) and Quality (PTQ and PDQ) will be key to execute the role successfully.
Your responsibilities
As Global Clinical Supply Chain cGMP Compliance Manager, you will be responsible for the following:
● 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 a business member on the Compliance Quality Council.
● 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. Where applicable, start and/or lead communities across PTD(S) to maintain and improve the compliance within 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
Who you are
In this role, you will bring the following qualifications and experience
● 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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Kaiseraugst, Aargau, Schweiz Roche VollzeitCompliance Expertise for Global Clinical Supply ChainThe Global Clinical Supply Chain (GCSC) organization at Roche is seeking a highly experienced Compliance Manager to ensure the right product is in the right place at the right time every time. As cGMP Compliance Manager, you will be responsible for maintaining and improving compliance with Roche PQS, GxP...
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