Under the direction of the Head, Program QA & Compliance, this position is responsible for leading and supporting the QA and Compliance activities of assigned programs managed by the Clinical Development and Global Medical Affairs organizations. The Program Compliance Lead has the depth of understanding, experience in GCP and compliance, leadership, communication skills and business acumen to conduct responsibilities unsupervised.
Key areas of accountability for this role are to provide professional expertise and strong leadership in Good Clinical practice (GCP), Good Pharmacoepidemiology Practice (GPP), and applicable regulations and guidance; proactively identify and escalate (as required) compliance status and issues/risks in assigned programs; assist the Head, Program QA & Compliance to offer direction and coordination to other team members; and promote QA & Compliance vision, mission and goals and communicate them in the spirit of a shared partnership, while motivating others through personal leadership, accountability and credibility.
Primary responsibilities include, but are not limited to: liaise with various internal R&D functions and external stakeholders, ensuring a high level of quality and consistency across the program of studies; lead the development and execution of audit and compliance plans and activities for assigned programs; assist program teams in implementing corrective and preventive actions, as required; enable program teams to be inspection ready and support a culture of sustainable compliance; actively engage with teams and activities for assigned programs; and assume complex assignments on issues or studies where there is no precedent.
50%: Compliance Support
Execute the overarching strategy related to proactive and sustainable compliance for the assigned programs. Active advisor/consultant in compliance related matters for assigned programs/projects. Active participant as QA&C representative in study team meetings, as appropriate. Support program and project teams in implementing corrective and preventive actions. Support project teams to be inspection ready within a culture of sustainable compliance. Provide/present, as required, the appropriate metrics for tracking, trending for the overall reporting requirements to functional and senior management.
Act as a trusted advisor, often on complex issues that lack precedence or are not clearly defined. Develop and/or review SOPs, Policies, Charters, etc. as needed. Mentor and assist QA&C representatives and/or other programs on compliance issues, as needed. Provide regulatory interpretation of impact/application to operation procedures of new/current regulations, guidelines, trends, etc.
25%: Create and Execute Program Compliance and Audit Plan
Develop the audit strategy for assigned programs. Lead the execution of the audit activities associated to GCP, GPP, and applicable regulatory requirements. Assume the SOP defined 'Program Lead' roles and responsibilities. Collaborate with key stakeholders from program teams, Audit Coordinators and/or other Program Compliance colleagues to ensure audit plan execution. Ensure the corrective and preventive actions are appropriate and completed in a timely manner. Oversee the timely development and distribution of audit reports and follow up actions. Assist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation. As appropriate, escalate issues of critical noncompliance and/or lack of urgency in remediation to senior management Mentor and provide support regarding audit process.
15%: Regulatory Agency Inspection Support
Leads and manages the execution of strategies for the preparation, hosting and responses to regulatory agency inspections for GCP/Sponsor Monitor inspections and investigator site audit inspections for assigned programs. Host or cohost regulatory inspections, as needed
Provide management and oversight to auditors contracted to provide auditing services for assigned programs. Coordinate with Quality Operations audit support staff, as required.
Participate in due diligence activities, as requested.
Participate in process improvement initiatives, as requested.
Work closely with supervisor to manage current issues and anticipate upcoming auditing needs outside of assigned programs.
As needed, may act as a supervisor for temporary contractors.
As appropriate and needed, act as stand-in for Head, Program QA & Compliance.
Education & Experience Requirements:
• Bachelor's degree required with a life science focus preferred; Masters Degree in management or scientific discipline a plus.
• A minimum of 10 years of relevant pharmaceutical experience.
• Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, GCP QA and/or GCP Compliance with 3 years of management experience.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.