Program Manager - Clinical Quality Assurance

Job Description
The Program Manager - Clinical Quality Assurance is primarily responsible for leading the management of GCP quality activities in support of studies and
Projects across one or more clinical programs to drive proactive quality management, and ensure
Compliance with corporate policies and functional procedures and applicable global regulations.
As the primary GCP quality interface cross-functionally in R&
D for the product, this individual will
Influence and provide oversight of activities that include execution of the Comprehensive Quality Strategy
Game plan, informal surveillance, assessments as appropriate, design and execution of a “fit for purpose”
Audit program with the goal of submission-ready quality data, first pass approvals by health authorities for
Market authorizations, and bringing our compounds to our patients. This is an independent contributor
Role that will influence across matrix organizations.
Responsibilities:
Develop and manage project timelines and deliverables for the RDQA Comprehensive Quality Strategy plan, including a lead role in Risk and Issue Management
Assess the success and effectiveness of the quality system and assure inspection readiness by designing an audit program of internal and external compliance audits and applicable assessments
Interpret, explain and apply applicable current governmental regulations, guidelines, policies and procedures to study protocols and associated activities
Prioritize activities to ensure objectives of studies/programs are met
Interact with Development Operations organization and supporting functions to ensure quality compliance across all aspects of clinical development;
Identify and mitigate potential clinical quality risks and escalate to management;
Leverage knowledge of clinical development to maintain program oversight and influence proactive quality management through quality related activities;
Provide project/programleadership in quality as a team member across clinical development functions
Anticipate, influence, and determine present and future business needs in support of quality for a drug development program
Lead the effort to articulate and present an integrated cross-functional and comprehensive quality strategy plan
Identify and implement balanced fit-for-purpose quality management;
Develop and recommend strategies and tactics for success
Identify and remove barriers that could impact program objectives, priorities, timelines, and quality. Communicate risks and mitigations to management
Serve as the primary program quality liaison during health authority inspections