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| Head of Quality Management / Pharmaceutical Development Sites |
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The Head of Quality Management / Pharmaceutical Development Sites will lead and manage all quality related aspects of CMC (NCE) Development and Biotech Products Development activities, including the analytical and formulation development, stability testing, manufacture, packaging, randomization, labelling, release and distribution of investigational medicinal products, and development of devices. The main tasks are:
- 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 QA managers of the development sites in the management of project and study related activities, complaints, deviations and audits and their follow-up;
- To define global quality systems for all development specific processes together with the relevant local quality units;
- To liaise with the Head of QM Biotech Drug Substance Sites regarding NBE Process Development.
MAIN TASKS & RESPONSIBILITIES
Managing Quality for Pharmaceutical Development and Medical Devices for relevant TechOps and RD/NCD sites
Assure the optimal GMP Quality Organization in area of responsibilities:
Ensure that GMP requirements and Merck Serono Standards are implemented and respected all over the Pharmaceutical Development sites
Ensure that Regulatory Compliance is in place and efficient
Define Merck Serono quality standards in terms of development specific GMP related matters together with the locally responsible QA managers
Establish quality standards and guidelines in the area of technical expertise
Realize GMP audits of the CMC (NCE) Development, Biotech Product Development and Clinical Trial Supply sites and follow-up the action plans
Ensure site inspection readiness prior to inspections by health authorities
Advisory capacity and supervision of training and education in QA and GMP matters to the QA staff in area of responsibility
Critical trouble shooting and corrective action follow-up
Support outsourcing & in-licensing activities
Organize and lead quality improvement projects and teams
Evaluation of development specific GMP related regulations and evaluation of the impact on Merck Serono CMC Development, Biotech Product Development and Clinical Trial Supply activities
Assess the quality risk in the area of responsibility and advise management of potential consequences
Regular visits to the sites
Ensure consistency of quality systems in borderline topics to GCP together with global clinical quality assurance
Support local development sites in supervision and control of CMO/CRO.
Provide overview of CMO/CRO that are used by the different sites and their qualification
Support Medical Device Development in terms of quality related matters and processes
Strategy:
Contribute to develop and implement a Quality Strategy for Tech Ops MS
Performance Management:
Contribute to define and follow-up Standard Quality KPI (Complaints, Rejects, Recalls, Audits and Health Authorities results, etc.)
Regular reporting to Vice President of Quality Management
People Management:
Lead and motivate the Quality Management team in the achievement of their objectives
Encourage 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
Direct reports:
Set operational objectives
Recruit personnel and develop retention / succession plans for key positions
Indirect reports (Functional managers at site):
Set operational objectives in collaboration with respective CMG Head / Site Manager
Decide with CMG Head / Site Manager on recruitment of Quality Unit Manager or QA / QC positions on Tech Ops MS sites
Decide with CMG Head / Site Manager on retention and succession plans for key positions |
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Doctorate
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10 years + |
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French : Speak Fluently
German : Speak Fluently
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 sciences (Pharmacy, Chemistry, Biotechnology)
Fluent in English and in German or French (written and verbal communication) - additional languages preferred
Minimum of 10 yrs work experience in quality assurance and / or quality control and /or pharmaceutical development in the pharmaceutical industry
International working experience preferred
Experience in GMP audit
Demonstrated ability to work in and lead international, multi-cultural teams
Strong Knowledge of Business Regulations (EU, FDA and others), especially in the field of pharmaceutical development and clinical trial supply
Excellent interpersonal and communication skills
Strong business mindset with demonstrated ability of analytical thinking
Good project management skills
Candidate must be prepared for business travel requirements to the sites
Teamwork
Relationship Management: Customer & Supplier Focus
Leading People
Developing People
Strategic Orientation
Result Orientation |
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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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