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Clinical Vendor Compliance Lead

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POST DATE 9/13/2016
END DATE 11/22/2016

Shire Pharmaceutical Lexington, MA

Lexington, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Job Description
Under the direction of the Head, Clinical Vendor QA & Compliance, this position is responsible for leadership of the QA and Compliance activities related to clinical vendors managed by the Clinical Development and Global Medical Affairs organizations. This person in this position 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 and quality issues/risks for assigned clinical vendors; assist the Head, Clinical Vendor QA & Compliance to offer direction and coordination to other team members; 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 collaboration with various internal R&D functions and external stakeholders, including contract auditors and vendor representatives, ensuring a high level of quality and consistency; lead the development and execution of audit and compliance plans and activities for assigned vendors; assist teams in implementing corrective and preventive actions related to clinical vendors, as required; assist teams to be inspection ready and support a culture of sustainable compliance; actively engage with internal and external teams for assigned vendors; assume complex assignments on issues where there is no precedent; and support a culture of sustainable compliance and inspection readiness.

40% -- CLINICAL VENDOR AUDIT MANAGEMENT: Develop audit strategy for assigned clinical vendors that support Clinical Development and Global Medical Affairs 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. Collaboratively work with key stakeholders from Program QA & Compliance, Program/Project teams, Audit Coordinators, and clinical vendor management groups to execute audit plan. Liaise with and provide oversight to auditors contracted to provide auditing services for assigned vendors. Coordinate with Quality Operations audit support staff, as required. Oversee the timely development and distribution of clinical vendor audit reports and follow up actions. Ensure the corrective and preventive actions are appropriate and completed in a timely manner. Identify potential systemic gaps and coordinate with the appropriate stakeholders 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 on audit process to QAC colleagues and other stakeholders. Work with supervisor to manage current issues and anticipate upcoming auditing needs outside of assigned programs.

25%-- CLINICAL VENDOR QUALITY MANAGEMENT: Lead clinical vendor quality governance teams and actively participate as the QA&C representative on operational governance teams as assigned. Liaise directly with vendor QA colleagues to address quality and compliance issues. Work with vendors and other internal R&D functions to perform root cause analysis of compliance issues for clinical vendors and support implementation of corrective and preventive actions as needed. Provide trending of vendor quality metrics to governance teams, functional and senior management.

20%--COMPLIANCE SUPPORT:Execute the overarching strategy related to proactive and sustainable compliance for clinical vendors. Advise/consult in compliance matters related to clinical vendors. Act as a trusted advisor, often on complex issues that lack precedence or are not clearly defined. Develop and/or review SOPs, Policies, Charters, process improvement initiatives, etc. as needed. Mentor and assist QA&C and/or other representatives from other functions on compliance issues, as needed. Provide regulatory interpretation of impact of new/current regulations, guidelines, trends, to internal R&D functions to ensure adequate sponsor oversight of clinical vendors. Participate in process improvement and due diligence activities, as requested.

10%-- MANAGEMENT: Provide management and oversight to auditors contracted to provide auditing services for assigned clinical vendors. Coordinate with Quality Operations audit support staff, as required. May supervise temporary QA & C contractors. As appropriate and needed, act as stand-in for Head, Clinical Vendor QA & Compliance.

5%-- REGULATORY AGENCY INSPECTION SUPPORT: Supports regulatory agency inspections activities related to clinical vendors for GCP/Sponsor Monitor inspections, and investigator site audit inspections, as needed.

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, LSDs, GI/ Internal Medicine / Endocrine & HAE; 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.

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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Reasonable Accommodations
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.