Overview
Quality Assurance Content Manager Jobs in Woerden, Utrecht, Netherlands at i+solutions
Title: Quality Assurance Content Manager
Company: i+solutions
Location: Woerden, Utrecht, Netherlands
QA Content Manager (Responsible Person)
Introduction:
We dream of a world where no medical need goes unmet. Suffering or dying because of a lack of medicines is inhumane. That’s why we do whatever it takes to create better access to medicine for people around the globe. Our job is done when every person on this planet has access to the right medication & medical supplies at the right place and time. And we know how.
Since 2005, i+solutions has set the industry standard for health procurement. We drive an innovative agenda to improve global health supply chains. We combine procurement, training, project management, quality assurance and technical expertise to make a difference from the first to the last mile, closing the gap between patients and medicine.
Big dreams ask for big solutions. That’s why we work with global donors, countries and partners to make a difference daily. These partnerships enable us to scale our solutions, drive industry innovation, and conquer new challenges. Together, we combine big hearts with big data to improve supply chains that secure accessibility and care.
The Role/Main Responsibilities
As Quality Assurance Content Manager at medior level, you will report to the Head of Quality Assurance. In addition to managing and maintaining quality records and processes (DMS/QMS), you will be responsible for maintenance and assurance in diverse quality systems in: GDP assurances, client project management, vendor and product qualifications, GDP compliance, QC, data and computerized system governance, continuous improvement projects and verify Regulation and Standard updates.
i+solutions is a GDP, MQAS and ISO9001: 2015 certified and ISO-27001 ready organization that delivers products worldwide based on unmet medical needs.
In this role the Quality Assurance Content Manager helps the access to medicine to all that are in need of them through ensuring a continuous supply of high quality medicine.
Responsibilities:
- Ensure QMS standards, processes, records and practices meet i+ and external stakeholder requirements (e.g., ISO 9001, 13485, GxP, ICHQ9 and MQAS)
- Collaborate with customers, authorities, external auditors, or other (internal) stakeholders to support, problem solve and demonstrate QMS effectiveness and compliance.
- Participate or Lead in cross-functional project teams to develop project standards, implement projects and for continuous improvement purposes
- Collaborate with operations and supply chain teams to maintain and continuously improve GDP-compliant processes.
- Quality Documentation & Compliance: maintain, update and control QMS system and documents in line with the relevant guidelines.
– Provide oversight and ensure quality records within the QMS (deviations, complaints, CAPAs, audit records, change controls, testing etc) are properly resolved, documented and maintained. Provide support, intervene and where needed.
– Oversee multiple QMS-systems or related processes; perform risk activities and lead problem solving and continuous improvement thereof, notwithstanding workflow updates in QMS/DMS.
– Analyze trends in quality data, act on negative trends and support the Quality Management Review therein where needed.
- GDP Compliance and Audits (ISO, MQAS and GDP):
– Support internal and external GDP or relevant GXP / ISO and MQAS audits and inspections as head of back office
-Serve as a co-host and/or subject matter expert on GxP topics
-Assist in CAPA and follow-ups related to documentation findings.
- Perform RP activities
- Training and Quality Culture:
– Develop, train and manage training materials related to GxP and Quality Management.
– Support awareness programs on GDP compliance and DMS.
- Regulatory & industry standard updates:
Monitor, plan and implement updates in GxP / MQAS regulations and international standards.
- Support the team with daily operations activities
- Lead the qualification of wholesalers, laboratory suppliers and products
- Perform Quality Agreements and contract review with clients and other stakeholders
Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Life Science or other relevant field or equivalent experience.
- 8+ years background in a QA role within Life Science environment, with QA and QC experience
- 8+ years of experience with GDP, preferable MQAS and GMP standards
- Qualified lead auditor in ISO and GxP norms
- Experience in inspectorate preparation and management activities
- Thorough knowledge of ISO standards 9001, and preferably knowledge of 14644 and 17137, ISO 13485, ISO-27001 and ISO 31000 experience is an advantage
- Eligible to work as an RP and/or QP in the Netherlands and EU
- Experienced in maintaining quality records and QMS /DMS -related processes. GAMP5 and data governance experience is highly preferred
- Working knowledge on establishing and maintaining an effective Quality Management System, including complex improvements
- Working knowledge on KPI management and supporting management reviews
- Regulatory Affairs knowledge is an advantage.
- Knowledge / experience with MS-Office (Word, Excel, Outlook)
- Fluency in English is required
- Fluency in Dutch at least at B2 level is required.
Personal and professional skills:
- Resolute
- Result and service oriented
- Helicopter-view
- Problem Solving
- Precise and accurate
- Quality Awareness
- Team Player
What we offer:
- Working in a great team and a pleasant atmosphere
- A drive for purpose and a multi-cultural environment
- Teaming with professionals who put passion into our mission
- Excellent opportunities for personal development
- Travel expenses compensation
Values and background check
i+solutions has a zero-tolerance policy against sexual exploitation and abuse. i+solutions may conduct background and reference checks on applicants who accept job employment offers. Please apply with your CV and cover letter telling us why you think you would be a great fit for this position.
