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/program leadership 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