Quality Assurance Specialist
3 days ago
About the Role
Lifelancer is seeking a highly skilled Quality Compliance Manager to join our team. As a key member of our organization, you will play a vital role in ensuring the highest standards of quality and compliance across all aspects of our business.
Key Responsibilities
- Provide quality support for the development and implementation of a risk-based quality assurance strategy for all stages of products in non-clinical development, with a focus on maintaining the integrity of Amgen's research data.
- Support GLP compliance oversight through cross-functional collaboration with functional areas and stakeholder groups within Research in alignment with standard practices.
- Plan, conduct, and report out on risk-based R&D audits, review, negotiate, and approve responses to R&D audit findings, and provide oversight for compliance activities until finding closure.
- Manage deliverables and provide data and recommendations regarding the state of quality for processes, technology, laboratory, and external vendor performance.
- Support the establishment of regional expertise to ensure quality and compliance to local regulations as well as support research-specific data integrity, including technologies for data collection and measurement.
- Support Research for all quality management activities, including Deviations/CAPAs, Inspection Readiness and Management, compliance-related questions, and critical issues.
- Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods).
Requirements
- Experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.
- Experience with Quality Oversight of Nonclinical Trials, including auditing GLP phases, data, and final reports, as well as partnership with third-party vendors, suppliers, and partners.
- Oversight of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Trackwise.
- Detailed understanding of R&D activities and Global Regulations.
- Knowledge of the Regulatory Submission and Inspection Management procedures.
- Excellent verbal and written communication skills, including significant business writing abilities and active listening.
- Ability to transform business and stakeholder feedback into clear, efficient processes using straightforward language and format.
- Strong analytical, critical-thinking, and decision-making abilities.
- Degree educated.
About You
We are looking for an experienced professional with a passion for quality and compliance. If you have a strong background in Quality Management, Quality Assurance, or related fields, and are eager to take on new challenges, we encourage you to apply.
What We Offer
- Vast opportunities to learn and move up and across our global organization.
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
- A Generous Total Rewards Plan comprising health, finance, and wealth, work-life balance, and career benefits.
Location
Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next-generation workspace.
Estimated Salary
$80,000 - $110,000 per annum, depending on experience.
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