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Quality Management Director - Pharma
SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
Our client is a professional Biotechnology and Pharmaceutical organization, based in Basel-Stadt Switzerland.
Our client is a Global Pharmaceutical companies with their European HQ in Switzerland
- Responsible to develop and implement a strategic audit plan for internal audits in Clinical Development.
- Ensure that activities are conducted and reports written according to applicable regulations
- Plan and conduct audits of databases, vendors (clinical, bioanalytical) to assure compliance with local regulations, ICH and policies and procedures.
- Assess impact of audit findings on subject safety, data integrity, and business operations.
- Obtain audit responses from functional areas and/or vendors, and evaluate proposed corrections, corrective actions, and/or preventive actions for compliance with applicable regulations, guidelines, and policies.
- Escalate inadequate audit response to QA management.
- Lead investigations into scientific misconduct and/or serious breach of GCP.
- Analyze investigation findings to identify root/probable cause.
- Propose, document, and track appropriate corrective actions.
- Assure reporting of potential or confirmed violations, as appropriate, to regulatory agencies.
- Participates in systems monitoring and process improvement initiatives that enhance regulatory compliance and Clinical QA operating efficiency
- Manage audit teams, including outside contractor auditors, to assure compliance with objectives of this position.
- As assigned, review and approve audit reports submitted by contract auditors for content, format, regulatory risks, and compliance with SOPs.
- Promote consistent audit report writing standards.
- Report metrics associated with Internal audits to QA management, clinical development clinical development staff, and contract research organization staff.
- Evaluate if corrective and/or preventative actions are required, and monitor implementation
- Identify potential systemic compliance risks, through audit activities and data analysis, and elevate to immediate manager for immediate and long-term resolution
- Provide GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of research for timely product applications.
- Independently analyze and interpret regulatory requirements as they apply to functional responsibilities.
- Develop and conduct GCP compliance presentations at internal and external meetings, facilities or investigator sites as needed.
- Provide GCP compliance technical support during regulatory inspections of facilities to mitigate regulatory action.
- Contribute to the development, introduction and continuous improvement of QA systems and processes.
- Demonstrate and maintains proficiency in the knowledge and application of industry standards
- Bachelor’s degree required.
- Minimum 9 years of pharmaceutical clinical research and development experience
- Minimum of 6 years of clinical quality assurance experience required
- Experience working within a complex organization and demonstrated ability to work across functions and regions, at all levels
- Good working knowledge of the interpretation and application of international clinical trials regulations and guidance, and ICH Good Clinical Practice guidelines (in particular EMA and FDA regulations).
- Understands the overall audit process including design, conduct and reporting.
- Demonstrates good working knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject safety and data integrity.
- Experience in auditing internal processes in Clinical Development and auditing vendors, such as CROs and clinical laboratories.
- Inspection Knowledge: Experience in regulatory agency inspection conduct and management is desirable.
- Understands the phases, processes and techniques used to execute a clinical development program.
- Demonstrates proficiency in negotiation and conflict resolution.
Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.
Computer skills: Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.
Must be proficient in use of the Quality Assurance Audit Database
Experience in computerized system validation is desirable.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.