Director of Quality Systems - Page Mechanical Group : Job Details

JOB TITLE: Director Quality SystemsDATE PREPARED: March 4, 2024JOB 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 SystemManaging a fit for purpose QMS, that is aligned with appropriate GxP regulations, is phase appropriate and risk based in natureEnsure the QMS complies with overarching Quality ManualEnsure training strategies are phase appropriate and GxP appropriateEnsure concepts such as Change Management, Deviations and CAPAs are implemented in a GxP appropriate fashionManage 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 GxPsParticipate in the development and management of the Quality department budget and resource planningContribute 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 systemsPrevious experience with inspection management preferredExperience in Quality Systems e.g. Deviation, CAPA and Change management processesExperience of working in global cross functional teams, demonstrated ability in mentoring/ coaching/ directing staff to be quality advocates, influencers, leadersProvided vision and leadership within teams, internally cross-company and externally with stakeholdersStrong 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 levelVisible and credible advocate for compliance and quality concepts with excellent communication skills across all levels of the businessAnalytical and logical, is able to design and implement innovative, significant and complex business improvementsAbility to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions, actions and resolutionsSound customer focus, strong organization, communication (written and oral), influencing and negotiation skillsDemonstrated proficiency in English and standard MS Office applicationsAbout AVEOAVEO 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.#J-18808-Ljbffr