Operational QA Manager - based/Basel, 6 Months contract

Basel, Switzerland

Reference	LP-2018
Contract type	Contract

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.
Here at inVentiv Health Clinical at the moment we are looking to appoint an experienced "Operational QA Manager". Responsible for support Development Project Teams and provide quality and compliance guidance for development and implementation of preventive actions. This person will be seconded to our client in Basel-Switzerland, with a 6 months contract (possible extension if positive performance & need), on a Full time basis 100%. Start Date ASAP.



Main Responsibilities:

* Provide leadership and guidance during the development and execution of corrective and preventive actions (CAPA).
* Coordinate and review CAPAs to audits to ensure adequate root cause anal­ysis and systemic solutions.
* Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical observations are not resolved in due course.
* Identify ways to continuously improve quality and compliance with regula­tions and company standards, policies and procedures through partnership with Franchise personnel, Development Line Functions and Development QA groups.
* Represent Franchise QA in interactions with internal and external contacts and Health Authorities, as appropriate.
* Ensure inspection readiness by preparing clinical teams for FDA/EU/key HA pre-approval and sponsor-monitor inspections; provide inspection manage­ment support and follow-up post inspection.
* Ensure that Franchise compliance commitments are fulfilled on time.
* Provide interpretation of GCP regulations and company standards, guide­lines, policies and procedures to Franchise personnel.
* Drive the implementation of the annual Franchise Quality Plan; identify rele­vant areas to be addressed in future Quality Plans.
* Closely cooperate with the Franchise Continuous Improvement/Op Excel­lence groups; participate and provide Quality and Compliance input for pro­cess improvement teams.
* Closely cooperate with the Development QA Quality Systems Excellence, Au­diting and Compliance Excellence groups to ensure consistency of quality and compliance activities and effective communication.



Profile:

* Bachelor's Degree required (Life Sciences, Pharmacy or Medicines); PhD or equivalent desirable.
* Minimum 10 years experience in clinical development and the pharmaceutical indus­try preferably with at least 3 years in Quality Assurance/ Compliance roles.
* Good knowledge of inter­national GCP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regu­lations, other key HA guidance's, and current industry practice.
* Capable of working independently as well as part of a cross-functional team demonstrat­ing the ability to influence and create align­ment across multiple functional areas.
* Fluent in English (oral and written).



To apply for this position you must hold a Swiss passport or a valid visa to work there, and be willing to work office-based 100% for our client. Possible to set up consultant agreements as well, but this only for Contractors running their own GMBH or AG



Please apply via E-mail:

Contact:
Lara Pianca, BSc
Recruiter
Obere Wiltisgasse 52, Küsnacht, 8700 SWITZERLAND
P: +41 (0) 44 918 75 24

Expires on

6/14/13 12:48 PM

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