42 days ago on roche.com

Senior Quality Manager Chemicals - Direct Material Specification Lifecycle Management

Roche AG

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Senior Quality Manager Chemicals - Direct Material Specification Lifecycle Management

Senior Quality Manager Chemicals – Direct Material Specification Lifecycle Management

Switzerland, Basel-Town, Basel

As the Senior Quality Manager Chemicals - Direct Material Specification Lifecycle Management you are part of the Direct Material Specification Lifecycle Team.

This team plays a decisive role in the deployment and realization of the quality strategy of Direct Material (DM) specification lifecycle management for Pharma Global Technical Operations. The team is responsible for the development, implementation and life cycle management of DM specifications, the management of processes for Direct Material lifecycle management of specifications, and implementation and realization of the quality strategy for globally managed Transmissible Spongiform Encephalopathy (TSE) / Bovine Spongiform Encephalopathy (BSE) and Genetically Modified Organisms (GMO) services for Pharma Technical Operations (PT).

As the Senior Quality Manager of chemical materials you ensure that the risks for the “right to operate” and “quality supply” of products to our patients are minimized. You are responsible for ensuring that all global specifications including starting materials, intermediates, excipients, process aids, standard chemicals and purchased API’s comply with global regulations, industry standards and Roche’s high standards of quality of materials across sites globally.

In collaboration with all other PT functions, regions and sites, you are responsible for the development of global specifications including risk assessments by means of proactive risk management tools and approaches. In addition, you will be responsible for the end to end execution and planning process of specifications from development to retire across Roche sites (local and global sites) and External Quality Operations CMO.

Your tasks and responsibilities will include:

  • Development, maintenance, timely delivery and change control of direct material specifications within scope of this position
  • Approval and implementation of supplier specifications across PT sites that use these materials and accountability for the implementation of direct material internal release specifications
  • Execute supplier manufacturing specification capability assessments and lead continuous improvement activities of suppliers to improve quality of materials
  • Participate in global Supplier Quality activities and in the material transfer teams during material transfers to manufacturing sites and to CMOs according to plan
  • Execute, implement and train business processes for Direct Material lifecycle management of specifications

This position is located in Basel, Switzerland.

  • Who you are
    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

    You have a B.A. or B.S. degree (preferably in chemistry or chemical engineering) with at least 5 years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience. You bring working knowledge of GxP (GLP, GCP, GMP), FDA Guidelines and Points to Consider documents, applicable local and international regulations, and standards routinely used in the industry (Q7, ANSI, ISO, Federal Standards, IPEC, etc.). You bring detailed knowledge of drug product material manufacturing processes, laboratory test methods to include EP, USP, JP and ChP requirements and industry standards.

    In addition you bring the following qualifications:

    • Project management experience and the ability to coordinate projects, the ability to make sound decisions about scheduling, coordinating, and managing priorities as well as a sound level of flexibility in problem solving to meet business objectives
    • Strong interpersonal skills which include a professional demeanour when interacting with stakeholders at all levels within Roche worldwide operations, suppliers, contract manufacturers, regulatory agency representatives
    • High flexibility and strong problem solving skills to meet business objectives
    • Basic knowledge of OE tools; i.e. statistical methods, FMEA, Six Sigma, Lean. Knowledge of Documentum, Condor, TrackWise, Change Control and SAP are considered a plus
    • Excellent verbal and written communication skills in German and English, ability to influence others and work as part of a team

    This position may require up to 10-15% national and international travel.

    Please apply until: 12 November 2017.

  • Who we are
    Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

    Roche is an equal opportunity employer.
  • Job facts
    • Location Switzerland, Basel-Town, Basel
    • Function Quality & Compliance
    • Subfunction Quality Assurance
    • Schedule Full-time
    • Job level Individual Contributor
    • Job type Regular Employee
    • Division Roche Pharmaceuticals
    • Posted since 2017/11/27
    • Job-ID 2953486052
  • Get in touch
    Marion Troian +41 61 688 54 31

    Work location: Basel, Switzerland