Quality Assurance Content Manager
Job Title: Quality Assurance Content Manager
Job Family: Content Manager (seniority: Medior)
Location: Woerden, the Netherlands
Reports to: Head of Quality Assurance
The Role
As a Quality Assurance Content Manager (Medior Level), you will report directly to the Head of Quality Assurance. In this role, you will be responsible for managing and maintaining quality records and processes within our DMS/QMS systems, while supporting and safeguarding a broad range of quality assurance activities.
Your responsibilities will include maintaining and improving quality systems related to GDP compliance, client project management, vendor and product qualification, quality control, data and computerized system governance, continuous improvement initiatives, and monitoring regulatory and standard updates.
i+solutions is a GDP, MQAS and ISO 9001:2015 certified organization and ISO 27001-ready company, committed to delivering healthcare products worldwide based on unmet medical needs.
As Quality Assurance Content Manager, you will contribute directly to improving access to medicines by helping ensure the continuous supply of safe, high-quality healthcare products to people who need them most.
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
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.
- Quality Documentation & Compliance: maintain, update and control QMS system and documents in line with the relevant guidelines.
- 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
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.
Apply now!
Please apply with your CV and cover letter telling us why you think you would be a great fit for this position: