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Sr. Manager QC: Stability, NPI & New Technology

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Job Description


Goal of the function/Primary objective of the Job

  • Support the broader organization/business with knowledge of the product stability of JSC Large Molecule products
  • Support the broader organization/business by providing governance via the Large Molecule stability committee to the stability programs in the different development phases of the product
  • Responsible for managing the NPI activities of the One Lab associates engaged in transferring primary and secondary analytical method and technology transfers to ensure compliance with quality standards
  • Responsible for the release of Raw Materials; Drug Substance and Drug Product form internal and external stakeholders
  • Responsible and support the department for Continuous improvement using Business Excellence tools
  • Responsible for internal and external scouting of the new technologies to ensure the future business requirements and capabilities are captured in the organization

Reporting Lines

  • Supervisor: Director QC
  • Direct reports: Managers (1), supervisor (2), Sr. Analyst (1) 

Tasks and Responsibilities 

Technical and job specific

    • Maintain oversight on the implementation of new guidelines, regulations, global standards and SOPs related to stability management and execution
    • Review and authorize stability protocols and reports
    • Maintain oversight of the quality performance of the OneLab department
    • Participate in Management review meetings 

Managerial

    • Manage the Stability, NPI & New Technology group
    • Follow up activities, projects, etc. in the group in order to meet the primary goals and objectives stated in section 2 above “Goal of the function/Primary objective of the Job”
    • Maintain an optimum organizational structure to support the key objectives
    • Ensure that the group has sufficient resources to manage its responsibilities
    • Manager the budget of the group with regards to planning and allocations
    • Continuously support direct reports from technical and managerial point of view by organizing recurrent group and face to face meetings
      • Continuously follow up the performance of the group:
      • Define KPI’s and scorecards
    • Maintain contacts with customers and stakeholders
    • Identify developmental needs of direct reports and define appropriate actions 

Compliance

Employee safety and health

  • Ensure that procedures and guidelines linked to safety and health are met 

Environmental care

  • Ensure that the group complies with the environmental procedures and guideliness 

Quality

  • Ensure overall compliance to regulatory cGMP requirements, global standards, procedures, etc.
  • Ensure that data are generated and maintained according to current regulatory requirements 

Financial Management

  • Manage group within budget

Job interaction areas 

Internal: Functional departments within Stability and Large Molecule hub of One JSC Lab

  • Stability Lab in Titusville and Raritan US and ADPC India
  • Large Molecule lab in Leiden, Manati, Schaffhausen, Cork and Malvern

                              Functional departments within JBV

  • Site Leadership Team
  • QA/QC Management Team

                              CMC regulatory compliance group

                              QA external manufacturing

                              PDMS
                              PQM
                              Finance department
 

External: Contractors, CMO’s

Key result areas of the Job 

Social-/Personal

  • Good and open relation with people across departments and within the department
  • Customer orientated
  • Relation of trust with direct reports
  • Be considered as authority in the job area

 Methodical-/Technical   

  • Shelf life of products on the market supported by scientific data
  • Compliance with cGMP requirements
  • Successful audits (compliance, safety, health & environment, etc.)
  • No major safety, health and environment events
  • Budget under control
  • Continuously growing organization (experience and technical skills of employees)

 Compliance to applicable procedures      

Accurate and timely reporting of stability data

    • Adequate management of OOS/OOT results
    • Expertise in stability behavior of portfolio products


Qualifications

Profile needed for this function

Education / Qualification

  • Master degree in chemistry & biotechnology or equivalent by experience with 8-10 years’ experience in the pharmaceutical industry. 

Professional experience

  • Experience in Quality Control, Method development, validation, etc.
  • Profound knowledge of pharmaceutical regulations/cGMP principles (FDA, EU, JPN, etc.)
  • General knowledge of pharmaceutical development & manufacturing
  • Organizational planning and problem solving experience
  • Strong leadership & development qualities
  • Experience with principles of Process Excellence, Lean manufacturing, etc.
  • Good presentation skills
  • Excellent knowledge of English
  • Managing and leading a medium size group 

Personal and interpersonal skills

  • Conflict handling
  • Decision taking
  • Analytical thinking
  • Strong Quality Awareness
  • Flexible
  • Stress resistant
  • Organizational and people management skills
  • Dealing with intercultural differences
  • Empathic
  • Deal with multiple tasks at same time
  • Negotiator
  • Motivator
  • Work independently

 

Personal attitude            

  • Team player
  • Communicative
  • Open minded
  • Listener
  • Open for change and improvement
  • Accurate and analytical mindset

 

Other attributes

  • Willingness to travel

Primary Location
Netherlands-South Holland-Leiden-
Organization
Janssen Biologics (7266)
Job Function
Quality
Requisition ID
1905791211W