Quality Expert

Quality Expert - contractor role

Work location: J&J Beerse, Belgium - remote

Organisation/Department:

As the Quality Expert you drive, Implement and Support projects in Transportation and Temperature Control as the Quality Expert on Compliance and Regulatory requirements, which have a significant supply chain, distribution, transportation and Temperature Control component

Duties & responsibilities:

• Must be familiar with current and emerging regulations and to understand the impact to quality and distribution practices
• Responsible for designing approach, reviewing and approving requirements for transport qualification, adherence to temperature control and monitoring requirements during transportation activities
• Supports validation/qualification of temperature controlled systems (cold chain and controlled ambient) and temperature control related projects (eg. shipping route verifications)
• Ensures appropriate documentation in compliance with regulations and standards of project activities
• Central point of contact for Transportation and Temperature Control Quality requirements as it relates to assigned projects.
• Responsible for transportation and temperature control change control documentation from initiation through implementation and closure.
• Remains current on assigned quality system training and seeks out training and knowledge in adjacent areas.
• Provides detailed or summary communication to QA and cross-functional management on status of key initiatives, projects and issues.
• Documents rationales which are technically accurate and regulatory compliance focused. Holds business partners accountable for delivering documentation of similar quality.
• Escalates and/or troubleshoots quality/compliance issues, using experience, resourcefulness, and creativity to provide solutions to a wide range of root causes.
• Fosters working relationships with internal business partners to understand regional and sector requirements and business challenges.
• Independently represents Quality Assurance function on multiple, simultaneous, high-impact/high-value projects as the “Voice of Quality”, including active team engagement, proactively ensuring that quality and compliance inputs are integrated into project objectives, and acts as a QA “go-to” resource for global transportation and temperature control business partners.
• Independently leads and prioritizes complex and diverse workload, ensuring that actions are on-time, accurate, and meet their intended objective

Experience & Education:

• Distribution / Transportation / Temperature Control requirements of Medical Devices and/or Pharmaceutical products
• Understanding the linkages in quality and regulatory compliance within Supply Chain activities
• Qualification and Validation experience, Compliance experience, QMS experience.
• Decisive, organized, and able to manage and prioritize a complex and diverse workload
• Strong communication skills, able to inspire trust and quickly build credibility
• Strong collaboration and influence skills to partner effectively across functions and operating units
• Accountability, with a strong desire to commit, be held accountable for delivering results
• Ability to fit in well culturally in a complex organization
• High tolerance for ambiguity in a complex environment
• Able to have big picture approach while paying attention to details
• Able to lead projects from a quality and compliance point of view within a complex business and supply chain environment
• Proficient in English
• be able to work hours to support Global meetings (in EMEA: until 6PM CET)

Offer:

You can fill this position through Randstad Professionals as a consultant (with an employee or freelancer contract)

In return for your performance and flexibility, we offer you a salary package with some interesting extras, such as

• Gross salary according to your experience
• Lunch vouchers of €7 per day worked
• Net remuneration of €80 per month
• Hospitalisation insurance
• 1 extra day's holiday per month worked
• End of year bonus
• Pension Plan
• ECO vouchers worth €250 (on an annual basis, pro rata)
• Training opportunities