2 days ago

CD Operational Excellence Officer

Actelion Pharmaceuticals Ltd

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CD Operational Excellence Officer

CD Operational Excellence Officer-(1700006V)

Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for a CD Operational Excellence Officer.


As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.


Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.


Job Responsibilities

* Ensure Operational Excellence by continuously developing the Quality System (QS) for Global Clinical Development (GCD) together with SOP Authors and Function Heads (FHs)
* Identify gaps in Clinical Development Operations (CDO) and/or cross-functional processes, and suggest strategies for improvement
* Maintain oversight of the QS for GCD, and regularly report on its status and performance to the FHs
* Prior to the publication of new or revised cross-functional SOPs in Quatro, ensure their review for consistency, alignment with other SOPs, and operational excellence, applying agreed standards
* Involve relevant Roles in the management of cross-functional SOPs as per the agreed standards, and support SOP Authors in implementing received comments
* Review and edit process-related SOPs prior to Editorial Review by the Head GCD
* Ensure proper cancellation of SOPs in Quatro as per the agreed standards
* Create or revise SOPs in agreement with relevant SOP Authors and FHs
* Track, trend, and follow-up on raised non-compliance affecting GCD as per the agreed standards
* In alignment with Clinical Trial Team (CTT) Members and Global Quality Management (GQM) Members analyze findings from audits, inspections, and non-compliances, and propose, develop, implement, and drive Root Cause Analysis (RCA) and Corrective Actions and Preventive Actions (CAPAs)
* Provide GCP consulting to CTT Members or projects interfacing with GQM Members
* Proactively contribute to the gathering and consolidation of information requested by Health Authorities (HAs), in close collaboration with GQM
* Support inspection readiness of GCD and contribute to the coordination of internal or external inspections
* Provide support as needed during HA inspections
* Review new or revised regulations / guidance documents (as received from GQM Members), and propose revisions to existing SOPs or create new ones as appropriate, in close collaboration with concerned FHs
* Consult GQM Members or other Subject Matter Experts (SMEs), as needed
* Other duties, activities, and projects, as assigned


Candidate Requirements

* University degree (or equivalent) in life sciences (biology, pharmacy, medicine, or related disciplines)
* 10 or more years' experience in Clinical Research and Drug Development and must include cross- functional disciplines
* Prior experience in the management of SOPs and Quality Assurance (QA)
* Understanding of roles and responsibilities of all relevant Functions involved in clinical studies
* Knowledge of International Conference on Harmonization - Good Clinical Practice guidelines(ICH-GCP) / and other relevant clinical study regulations
* Excellent verbal and written communication skills
* Excellent English, other languages advantageous
* Excellent computer systems and software skills
* Strong experience in working in global cross-functional (matrix) and multicultural teams


Behavioral Skills


* Extensive facilitation, presentation, and consultation skills
* Experience in driving business process improvement projects
* Demonstrated analytical skills
* Proven track record of effective persuading and influencing skills
* Problem solver, displays a "can-do" attitude and forward thinking in initiating change
* Strong attention to detail, knows how to establish priorities and meeting timelines
* Ability to manage people and to provide clear direction and coordinating actions
* Team player and ability to work across all levels of an organization in a global matrix environment


If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we look forward to your application. Please include your CV and a cover letter.


Primary Location

:CH-BL-Allschwil

Job

:Quality

Schedule

:Full-time

Job Type

:Standard

Job Posting

:Aug 23, 2017