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Audit Compliance Support Specialist

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POST DATE 9/7/2016
END DATE 11/8/2016

Shire Pharmaceutical Lexington, MA

Company
Shire Pharmaceutical
Job Classification
Full Time
Company Ref #
14443BR
Location
Lexington, MA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree
AJE Ref #
576110289

JOB DESCRIPTION

Job Description
PRIMARY ROLE:
Under the direction of the Head, QMS Systems and Logistics, this position is responsible for supporting the QA and Compliance activities managed by the QA&C Program Leads (PL).

This position is responsible for maintaining the department s Master Audit Plan (MAP) and managing the Contract Auditors who conduct the audits in the plan. Coordinating the maintenance of a centralized audit schedule to assist PLs in selecting auditors based upon experience, qualifications and availability. Ensuring that all auditors are fully trained on Shire procedures.

Fosters a culture of continuous improvement and identifies opportunities to further enhance quality and compliance using process and technology.

RESPONSIBILITIES:
60%: AUDIT LOGISTICS SUPPORT
* Support PLs in R&D QA&C in the planning and the execution of the
audit plan.
* Coordinate and support the development and updates of audit plans.
* Work with PLs to identify auditors, verify and ensure auditors training,
qualifications and contacts are current.
* Ensure the completion of SOWs and related documents.
* Update information in the appropriate audit trackers/systems in a timely
manner.
* Manage vendor list with coordination of vendor audits.
* Ensure all auditors are fully trained on Shire s procedures.
* Provide document preparation/tracking as needed to support regulatory
inspections.
* Assist QA&C Heads with program level management tracking and
reporting, as defined.

20%: COMPLIANCE/MANAGEMENT SUPPORT
* Provides operational and compliance support and direct support for
internal / external audits as appropriate.
* Provides program specific metrics for reporting to functional and senior
management.
* Manages the Master Audit Plan for QA&C, updating on a quarterly
basis.
* Manages the Contract Auditoring pool to support the audits in the
Master Audit Plan, including tracking Master Service Agreements,
training, and access to communication portals (i.e. SharePoint).
* Identifies, develops, and drive continuous improvement opportunities.

5-10%: DOCUMENTATION & TRAINING MATERIAL
Develops and manages system related training material for various users.

5-10%: SYSTEM DEVELOPMENT LIFECYCLE ACTIVITIES
Participates in the system development lifecycle by serving as a subject matter
expert, supporting validation efforts of new releases and performs user
acceptance testing.

EDUCATION & EXPERIENCE REQUIREMENTS:
Bachelor s degree in a life science required.
* Minimum 3 years in IT/Quality Assurance in a Pharmaceutical environment supporting GxP systems is
preferred.
* Knowledge of US, EU, ICH regulations, guidance s and requirements.
* Ideal candidate will have broad experience in basic clinical operations, compliance principles in GCP
and strong organizational skills.

ABOUT SHIRE:
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.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

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.