layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

Senior Manager/Associate Director, Quality Assurance, GCP at Xenon Pharmaceuticals | LAYIQ

Bachelor’s degree in a scientific or health field with at least 8 years of GxP QA experience, 6+ years GCP QA, supporting both development and commercial programs in the pharmaceutical or biotechnology industry.
A minimum of 3 years in a quality lead role in a pharma or biotech environment. Job level commensurate with years of experience.
Extensive knowledge of GCP regulations, guidelines, current industry trends, standards, and methodologies.
Sound knowledge of GLP regulations, guidelines, current industry trends, standards, and methodologies.
Experience interacting with regulatory inspectorates (e.g., FDA, Health Canada, EMA, MHRA) is desirable.
Strong understanding of all phases of the drug development process and the interdependencies with other functional areas, but experience in early phase (pre-phase 3) is required.
Experience in conducting audits, adapting issues into effective CAPAs, and evaluating trends to mitigate risks.
Ability to effectively prioritize and manage multiple complex projects in parallel and successfully achieve critical milestones and expected deliverables within established timelines and budgets.
Must be able to demonstrate strategic thinking, excellent organizational skills and be able to drive project teams forward while having willingness to do the work to achieve goals.
Demonstrated ability to interact professionally and communicate clearly, concisely, and consistently both verbally and in writing with internal and external stakeholders.
Proven ability to work independently and collaboratively as part of a multidisciplinary team.
Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

Senior Manager/Associate Director, Quality Assurance, GCP

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