Senior Systems Quality and Compliance Specialist
Organon
full-time
Posted on:
Location Type: Office
Location: Lisbon • 🇵🇹 Portugal
Visit company websiteJob Level
Senior
Tech Stack
SDLC
About the role
- Provide quality oversight for GxP computerized systems throughout the SDLC.
- Ensure compliance with applicable regulatory requirements, internal policies, and procedures.
- Support validation activities, including planning, execution, and documentation.
- Develop and maintain validation documentation, SOPs, training materials, and quality alerts.
- Collaborate with cross-functional teams to identify and implement quality improvement strategies.
- Review audit and inspection findings and support remediation efforts.
- Engage with internal and external stakeholders to ensure alignment on quality expectations.
- Manage relationships with third-party vendors and development partners.
- Support IT project delivery with a focus on quality governance and compliance.
- Participate in global projects and work effectively in multicultural environments.
Requirements
- Bachelor’s degree in Science, Pharmacy, Computer Science, or Business Administration.
- Minimum of 5 years of experience in Quality Assurance or Compliance in the pharmaceutical or biotech industry.
- Strong understanding of computerized system validation principles and global regulatory requirements.
- Experience with validated solution delivery, regulated application support, or vendor oversight.
- Familiarity with quality systems implementation in pharmaceutical, laboratory, or manufacturing environments.
- Excellent communication, facilitation, and stakeholder engagement skills.
- Ability to work independently and manage multiple priorities in a dynamic environment.
Benefits
- Flexible Work Arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GxP computerized systemsSDLCvalidation documentationSOPsquality improvement strategiesaudit findings reviewremediation supportvalidated solution deliveryquality systems implementationcomputerized system validation
Soft skills
communicationfacilitationstakeholder engagementindependent workpriority managementcollaborationcross-functional teamworkmulticultural environment adaptability