quality manager

Major accountabilities :

Operational

• 
  provide timely and efficient GMP/GDP IMP Release function related to the development of the pipeline projects (included all relevant activities for IMP release: label approval, batch record documentation, etc…).
• To support compliance with all relevant and appropriate regulations and guidelines
• To participate in the management of QA through active participation in QA forums and other meetings.
• To support in-licensing activities by providing Quality Assurance expertise for the evaluation of new project opportunities
• To support the systems and processes in place for the appropriate documentation activities and to maintain them in a manner compliant with regulatory and corporate requirements.
• To provide GMP/GDP expertise in the form of Training for members customer departments
• Ensure the CMC review and release related QA activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).
• Proactively support the activities of CMC and Clinical supply QA for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).
• Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
• Keep current on CMC guidance and apply as appropriate to development processes (ensure that the accurate and compliant processes are in place).
• To provide support in the evaluation of Temperature excursions for IMP.
• Management of Quality Complaint of IMP
• Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)
• Ensure adequate QA support for the qualification, validation and maintenance of the equipment,classified rooms, HVAC, computerized systems used in development manufacturing areas or laboratories, as well as related cleaning validations.
• Contribute the preparation of audits (internal/external, regulatory inspections)
• Implement and maintain adequate Quality & Compliance Indicators and communicate results to appropriate levels of the organization
• Ensure and maintain the adequate accreditation for the packaging facilities (CSO)
• Lead internal audits / Self-Inspections
• Activation of Master Data codes within SAP

Process

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  Ensure that all review and release, manufacturing and packaging operations are appropriately compliant with applicable regulations (EMEA, FDA, DEA, MHRA, etc. where relevant). Support the Head of CTS
• Quality Operations in ensuring an acceptable outcome of all audits and inspections, especially those by government agencies, as they pertain to Process Support and Package Development practices (whererelevant), equipment, and facilities.
• Actively participate in identifying, developing and implementing local quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems and developing solutions.
• Ensure Clinical supply QA processes directly support Technical Operations and development partner goals and objectives.
• Review and QA approval of deviations, change controls and complaints.

• Bachelor/Master degrre
• Experience in pharmaceutical regulated environment
• Must be knowledgeable in QA
• A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
• Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese)
• Function effectively with minimal supervision
• Good teamwork and project management skills. Must have strong, organization and analytical skills.
• Must be fluent in English, other languages are a bonus
• Facilitator, influencer and planner
• Fact based decision maker: understand complex issues and have the ability to contribute to informed decision making when working on “grey” issues
• Able to make/ influence quality/compliance decisions in a CMC development environment.
• Experience of participation in failure investigations
• Familiarity with risk analysis techniques

Consultancy

We offer an attractive salary with extra-legal advantages :

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc

A rate as freelance is also possible