Associate Director driving quality optimization for biopharmaceutical initiatives and regulatory compliance with project teams. Leading complex quality processes while collaborating with internal and external stakeholders.
Responsibilities
Provides consultation on particularly complex aspects of ‘GXP’ to project teams and sponsors
Drives the implementation of changes required to meet evolving regulatory requirements/industry developments
Leads or contributes expertise to process-related initiatives
Provides support to audits, inspections and Quality Issues, as assigned
Contributes expertise to designated initiatives
Provides expertise to project teams for issue management
Provides expertise for departments or geographies, as assigned
Contributes to regulatory inspections and sponsor audits, as assigned
Contributes to or leads designated initiatives (may be complex)
Directs others to resolve problems and/or conducts analyses (may be complex)
Decision Making - Makes decisions that impact the organization/department/business
Influence - Builds and extends relationships with new and existing internal and external customers
Provides expertise to identify, prevent, and solve problems (may be complex)
Drives solutions impacting the company
Stays abreast of new regulatory and policy developments
Accountable for the performance and direction of initiative teams were assigned as leader
Responsible for resourcing and budget negotiation for initiatives were assigned as leader
Directs and controls the activities of initiative teams were assigned as leader
May contribute to strategic planning from a quality or process perspective
May lead a team
Represents Corporate Quality and Syneos Health, as assigned
Performs other quality-related activities as directed by CQ management
Completes other Corporate Quality tasks, as assigned
Requirements
Minimum 4 Year / Bachelors Degree BA/BS degree in science or health care or equivalent education and experience
Requires detailed knowledge of GxP/regulatory/technical/process
Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), email and voicemail
Above average attention to detail and accuracy
Strong organizational, interpersonal and team-oriented skills
Ability to act independently and pro-actively
Significant project management and customer management skills
Ability to perform several tasks simultaneously to meet deadlines
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