Senior Quality Expert / Compliance Lead

Highly Competitive
  1. Contract
  2. Good Clinical Practice (GCP)
  3. Switzerland
Basel, Switzerland
Posting date: 16 Oct 2019
QA.TM.25820_1571236935

A job vacancy for a Senior Quality Expert/Compliance Lead has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas. This will be a contract position based in the company's Swiss office.

Job Responsibilities:

  • Lead design and implementation of "Just-In-Time (JIT)" training concept for OMA in 3Q.
  • Operate and monitor execution of JIT training in 4Q+.
  • Advise Pharma Medical Affairs on JIT training implementation (TBC).
  • Support OMA Global GxP Director on training management and operations (incl assignments and training compliance monitoring).
  • Provide ad-hoc support to key projects (namely GEMS rollout, HCP Experience).

Skills and Requirements:

  • Scientific qualification (PhD, MSc or Bachelor's Degree) in in an appropriate scientific discipline or quality-related field.
  • An in-depth knowledge of the international pharmaceutical product development process.
  • A minimum of 2 years' experience with GxP requirements, quality management system including risk management and regulatory requirements from main Heath Authorities.
  • Expertise in the principles and practices of Quality Risk management and/or GxP audits.
  • Able to understand and work with enterprise and functional systems & data
  • Experienced in implementing and deploying projects/ changes in an organization
  • A broad understanding of Quality Management, GCP / GVP and Risk Management processes
  • A broad understanding of main Health Authorities standards (e.g. FDA, EMEA) and ICH regulations and guidelines.
  • Proven self-starter with experience in building capabilities based on defined business needs across geography and functions.
  • Pharma experience; FDA Knowledge is an Advantage
  • Should be familiar with Quality management, Risk management, and documentations in a compliant way.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Tim Masson at +44 2038540237 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-TM2

#Compliance/Quality

close