Director, Investigations (Quality Control)

We are currently looking to fill an Associate Director/Director Investigations (Quality Control) position. This position is responsible for providing direction and oversight to the review, approval and management of investigations and corrective and preventive actions.In this role, a typical day might include the following:Leads a team with direct oversight of review and approval for GMP DocumentsMay review, verify and approve system recordsCollaborates cross functionally to provide succinct support to teams to strive to quality outcomesMay approve and review Policy/SOP revisionsProvides direction for cross-functional teams. Serves as an escalation point as well as determination when additional escalation is requiredIdentify leading practices and recommend improvements to continuously improve compliance profileServes as a subject matter authority (SME) to present topics to management and during inspectionsSupervises relevant quality system metrics including deviations and corrective actions. Uses metrics to identify and pursue initiativesDrafts and implements long-term planning for the process and staffPerforms personnel management functions (i.e. annual employee evaluations, coaching, mentoring, performance feedback, etc.)Makes decisions and develops and implements policies.Ensures that policies and procedures are effectively administered and align with regulatory requirements and current good manufacturing practices (cGMPs)Participates on internal committees/teams, as requiredThis role might be for you if you:Have experience leading a large team of quality minded individualsContinuously seek to improve processes for improved performanceHave detailed knowledge of cGMPsExcel in a quality driven organizationHave an understanding of biologics manufacturing operationsTo be considered for this role you must hold a Bachelor’s degree in Life Sciences or related field and the following amount of relevant cGMP manufacturing experience for each level:Associate Director – 10+ yearsDirector – 12+ yearsLevel to be determined based on qualifications relevant to the role. May substitute proven experience for education requirement.Salary Range (annually)$142,700.00 - $277,100.00

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