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Director of Quality Systems
4 months ago
JOB TITLE: Director Quality Systems
DATE PREPARED: March 4, 2024
JOB SUMMARY:
This position will drive the design and implementation of fit-for-purpose, phase appropriate Quality Systems. The Director of Quality Systems will establish the framework and provide strategic oversight of key aspects of the Quality Management System such as Document Management, Knowledge Management, Issue Management, Deviation and CAPA Management, Risk Management, Continuous Improvement, Inspection Management, and Change Management in addition to providing quality systems consultancy and advice. The Director of Quality Systems partners with Information Technology and Business Process Owners to ensure appropriate controls, validation plans and maintenance are in place for software tools deployed that require Quality oversight.
PRINCIPAL DUTIES:
Evolving the long-term strategic vision and framework for the Quality System / Quality Management System, including:
Managing the framework for all elements of a pharmaceutical Quality System
Managing a fit for purpose QMS, that is aligned with appropriate GxP regulations, is phase appropriate and risk based in nature
Ensure the QMS complies with overarching Quality Manual
Ensure training strategies are phase appropriate and GxP appropriate
Ensure concepts such as Change Management, Deviations and CAPAs are implemented in a GxP appropriate fashion
Manage the implementation and maintenance of GxP technology systems that will support the Quality System / QMS.
Develop and implement a data analytics program that provides insight into key drivers of performance and quality.
Work with stakeholders to determine the right KPIs/KQIs and methods for gathering, analyzing and presenting data in company governance level meetings.
Support an internal audit program to evaluate key processes and provide feedback for continuous improvement.
Provide QMS compliance consultancy across GxPs
Participate in the development and management of the Quality department budget and resource planning
Contribute to the development of the quality and compliance focused culture.
REQUIRED QUALIFICATIONS/EXPERIENCE (BASIC QUALIFICATIONS):
14+ years Pharmaceutical company experience combined between roles in Quality Assurance, Compliance, Quality Management Systems and/or in an operations related role(s)
Proficiency in VEEVA systems
Previous experience with inspection management preferred
Experience in Quality Systems e.g. Deviation, CAPA and Change management processes
Experience of working in global cross functional teams, demonstrated ability in mentoring/ coaching/ directing staff to be quality advocates, influencers, leaders
Provided vision and leadership within teams, internally cross-company and externally with stakeholders
Strong leadership role with knowledge of international and national laws, regulations and guidelines related to the conduct of Research & Development. Demonstrated self-confident, proactive and decisive decisions.
Past role demonstrated the following characteristics:
High ethical standards as well as acknowledged personal credibility, the ability to gain trust at the senior executive level
Visible and credible advocate for compliance and quality concepts with excellent communication skills across all levels of the business
Analytical and logical, is able to design and implement innovative, significant and complex business improvements
Ability to think strategically and to quickly analyze complex circumstances and problems,
and to drive appropriate decisions, actions and resolutions
Sound customer focus, strong organization, communication (written and oral), influencing and negotiation skills
Demonstrated proficiency in English and standard MS Office applications
About AVEO
AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO currently markets FOTIVDA (tivozanib) in the U.S. for the treatment of adult patients with relapsed or refractory renal cell carcinoma (RCC) following two or more prior systemic therapies. AVEO continues to develop FOTIVDA in immuno-oncology combinations in RCC and other indications, and has several other investigational programs in clinical development. AVEO is committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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