QA Validation Manager Biopharma
My client is looking for a someone interested in a long term collaboration that can come in and feel like home with Managing a team of Validation Specialists and thinks of a job where priorities shift fast if urgent problems come as a good challenge and not something to shy away from.
From the Board members to the hands-on specialists, everybody has a high passion for their trade... and the financial results are proof of that. But more about that over a phone call if you're interested and apply to the role.
As further proof of the support they give one another, if you'll need to relocate, they are willing to fully support you with that.
Essential Duties and Responsibilities include, but are not limited to, the following:
* You will manage, develop and build a team of subject matter experts in various validation areas.
* Management of resources, planning and assigning work to Validations Specialists and/or contingent workers.
* Managing multiple and complex validation programs, coordinating with other departments or outside contractors/vendors to complete validation tasks.
* Lead technical and quality investigations.
* Collaborates with functional departments to resolve issues.
* Manage cross-functional projects with many stakeholders.
* Review and/or approve master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
* Coaching and mentoring of less experienced Specialists.
* If required, internal and external (regulatory) audits.
* Some travel may be required.
Experience and Required Skills: Education and Experience:
* BS/BA in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field preferred; may substitute relevant experience for education.
* Previous team/people management experience essential.
* Previous cleaning validation and steam in place experience an advantage.
* Understanding of Biopharmaceutical Drug Substance manufacturing process an advantage.
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