Head of Technology QA and Compliance
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POST DATE 8/30/2016
END DATE 11/8/2016
JOB DESCRIPTIONJob Description
Under the direction of the Head of R&D QA and Compliance, this position is responsible for providing the strategic direction and compliance leadership to Computerized Systems Validation (CSV) and associated Clinical Trial Processes in the R&D organization. Primary responsibilities for this role are to develop and successfully implement auditing, inspection and compliance strategies for CSV applicable regulations and guidance s. Primary duties include but are not limited to liaising with various Shire IT stakeholders, internal R&D functions and external groups including Contract Research Organizations(CROs) who support and provide computerized services such as DM, Stats, ePRO etc., regulatory bodies and ensuring a high level of quality and consistency across systems used in R&D, the programs and studies. Contributes to the development of the master audit plan as a means to ensure compliance with appropriate policies and procedures, participates in due diligence activities as applicable and appropriate, serves in an advisory/consultative role in CSV compliance related manners, assists program teams in implementing CSV related corrective and preventive actions, enables program team to be inspection ready and support a culture of sustainable compliance.
30%: CREATION AND EXECUTION OF CSV PLAN
Leads the development and execution of the audit activities associated to CSV and applicable regulatory requirements audits . Collaboratively works with key stakeholders from Shire IT and other IT stakeholder groups, R&D and other Program Compliance colleagues to ensure a robust audit strategy. Ensures the appropriate corrective and preventive actions related to CSV activities are completed in a timely manner. Identifies potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation. As appropriate escalates issues of critical noncompliance and/or lack of urgency in remediation to senior management. Audit includes but is not limited to CSV, for cause or routine. In coordination and collaboration with IT, manages and maintains the R&D CSV Master Validation plans and reports.
30%: COMPLIANCE SUPPORT
Serves in an advisory/consultative role in CSV compliance related manners and supports systems used by R&D and Program team in implementing CSV corrective and preventive actions. Working closely with the QA & Compliance Quality Operations team and Program Compliance, supports Program teams to be inspection ready with a culture of sustainable compliance through identification and conduct of audits as well as providing guidance to CSV compliance. Works with the R&D QA & Compliance Quality Operations and the Internal Audit and Risk Management functions to perform root cause analysis of compliance issues related to CSV and process audits and provide the appropriate metrics for tracking, trending for the overall reporting requirements to functional and senior management. Participates in Due Diligence activities as appropriate. Develops an overarching strategy related to proactive and sustainable compliance for CSV Compliance for systems used in R&D.
Leads a team consistent with Shire s People Manager expectations:
Managing Performance: Ensure every employee knows what is expected of them, what it takes to be successful, and how they are progressing. Hold everyone accountable to achieve results while demonstrating Shire values.
Developing People: Help employees continually grow through challenging opportunities so they can realize their potential.
Fostering a Brave Culture: Show employees what Brave looks like by being a role model. Create the environment in which people are able to be Brave and a culture where any risks are always in compliance with applicable laws and regulations.
10%: R&D QA & COMPLIANCE LEADERSHIP
Serves as a member of the R&D Clinical and Medical QA & C Leadership Team to influence the operations and future strategy of the R&D Clinical and Medical QA & Compliance function
10%: REGULATORY AGENCY SUPPORT
Develops and manages the strategies for the preparation, hosting and responses to regulatory agency inspections as appropriate including participation in hosting and management of inspections as required.
EDUCATION & EXPERIENCE REQUIREMENTS:
Bachelor s degree in a life science or equivalent required; Masters Degree in management or scientific discipline a plus.
At least 10 years of pharmaceutical experience.
Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, GCP auditing and at least 7 years of direct management experience.
OTHER JOB REQUIREMENTS:
Domestic and international travel required. Must travel globally to sites where clinical and pharmavogilance colleagues operate. Must have a global mindset.
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.