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| Head of Quality Management CMGs & Distribution International |
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The Head of Quality Management CMGs & Distribution International will lead and manage all quality and compliance related aspects for the Merck Serono International CMGs with regard to GMP & GDP in alignment with the strategy defined with the Head of Quality Management CMGs & Distribution
Main areas of responsibility:
- to ensure that the defined quality systems and standards are implemented and followed
so that the high quality standards of the Merck Serono business and Merck are achieved;
- to support the locally responsible Quality Unit in the management of change requests, complaints, deviations , audits and their follow-up , inspections, submissions and improvement plans
- to create and lead a functioning network of Quality Management practitioners within CMGs to strengthen the organisational alignment and to ensure long-term product quality competitiveness distribution compliance and continuous improvement
- to collaborate with other Merck Serono functions (Global Regulatory Affairs, Drug Safety, R&D QA,…) and Merck Corporate Quality Assurance to ensure a sustainable high level of quality and compliance at CMGs level.
Managing GMP & GDP Quality requirements for International CMGs:
- Assure the optimal Quality organization in area of responsibilities
- Ensure that GMP/GDP requirements, Merck Serono and Merck Standards are implemented and respected all over the CMGs
- Ensure that regulatory compliance is in place and efficient
- Establish Quality standards and guidelines in the area of technical expertise
- Ensure and support implementation plans for e-QA systems and associated training
- Perform GMP /GDP audits of the CMGs and distribution activities and follow-up the action plans
- Ensure site inspection readiness for GMP & GDP prior to inspections by health authorities
- Advisory capacity and supervision of training and education in QA and GMP/GDP matters to the QA staff in area of responsibility
- Manage trouble shooting for critical deviations / issues and follow up corrective actions
- Support CMGs for qualification of storage and distribution routes
- Support outsourcing and in-licensing activities including audits
- Organize and lead quality improvement projects and teams
- Evaluate GMP/GDP related regulations and evaluate the impacts on CMGs activities and business
- Ensure effective use of Merck Quality Alert system.
- Participate in the decision-making process of recalls and ensure that adequate process is implemented at CMGs level. Coordinate medicinal product discontinuation/recall/withdrawal
- Arbitrate Quality decision to guarantee independence of Quality Unit Managers
- Regular visits to the CMGs to review quality management status and needs
Performance Management:
- Contribute to define and follow-up Standard Quality KPIs (complaints, rejects, recalls, audits, CAPA and Health Authorities results, etc.)
- Regular reporting to the head of TechOps Quality Management CMGs & Distribution
Interface Management:
- Coordinate with Merck CQA and other Merck Serono functional QA regarding Quality standards to be implemented at CMGs level
- Represent TechOps Merck Serono in professional associations
Strategy:
- Contribute to develop and Implement a Quality Strategy for Merck Serono regarding CMGs & Distribution.
People Management:
- Lead and motivate the Quality Management CMGs team in the achievement of their objectives
-Encoura ge Quality Management practitioners and project team members in the resolution of issues and problems
- Act as opinion leader in the promotion of the Quality Management ideals, concepts and practices throughout the organization.
- Provide coaching and skill development and foster best talent management |
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Bachelors Degree
Doctorate (Pharmacy, Chemistry, Engineering, Biotechnology)
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10 years + |
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French : Speak Well
German : Speak Well
English : Speak / Write Fluently
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open-ended |
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unspecified |
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International |
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Geneva |
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Doctorate or academic degree in natural or applied sciences (Pharmacy, Chemistry, Engineering, Biotechnology)
Fluent in English and in German or French (written and verbal communication)
Strong Knowledge of Business Regulations (EU, FDA and others)
GMP / GDP auditor
Excellent interpersonal and communication skills
Strong business mindset with demonstrated ability of conceptual and strategic thinking
Good project management skills
Candidate must be prepared for extensive business travel requirements to the sites
Minimum of 5 to 10 yrs work experience in quality assurance and / or quality control and/or production/ distribution in the pharmaceutical industry
International working experience preferred
Demonstrated ability to work in and lead international, multi-cultural teams |
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Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA.
Merck Serono’s global headquarters are located in Geneva, Switzerland. |
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