Shire Internal & Supplier Audit Support Specialist in Lexington, Massachusetts

Under the direction of the Head of Internal & Supplier Audits, this position is responsible for supporting the overall Internal Suppler & Audit (ISA) strategy and ensure adherence to R&D QA & Compliance (QA&C) Operational objectives. Primary responsibilities of this position are to:

  • Management and oversight of external auditors

  • Primary Administrator and/or User for ISA Systems: Supplier Database and SharePoint

  • Provide support for QA & Compliance Regulatory Agency Inspections

  • Provide coordination and support in execution of overall ISA strategy and R&D QA&C Operational objectives

  • Proactively identify potential areas of non-compliance and risk to R&D Business Partners and Shire.

R espons i b i l i t i es

20-30 % of Time

Audit Coordination

  • Provide support in the planning, execution and close out of assigned ISA audits and related communications

  • Support the development and coordination of audit plans and assignments

  • Escalation of potential issues with suppliers to appropriate personnel

  • Support ISA facilitated meetings

  • Participate in QA&C project initiatives (System Development and COE driven)

20-40%

External Auditor Oversight

  • Develop and manage relationships with external auditor partners

  • Manage the active and approved auditor pool and provide recommendations based on ISA requests

  • Manage master service agreements and associated addendums with external auditor partners

  • Develop consultants statements of works for ISA audits; collaboration with external business partners on amendments

  • -Support QA&C as needed in the identification, preparation and management of external auditors

15-40%

ISA/QA&C Supplier Database & SharePoint Management

  • Maintain and manage ISA/QA&C database and SharePoint site

  • Collaborate with internal business partners to implement required database and SharePoint updates

  • Assist and/or provide training on ISA/QA&C database and SharePoint as necessary

  • Serve as designated ISA/QA&C database and SharePoint super-user

5-15%

Regulatory Agency Support

  • Support, as needed, the preparation, conduct follow-up/responding, and lessons learned to GXP inspections

E duca ti on and E xpe r i e nce R equ i r e men t s

  • Bachelor’s degree in a relevant discipline or equivalent experience

  • Exposure working in pharmaceutical industry a plus

  • Ideal candidate will have experience in product development, regulatory compliance, supplier management, database and system administration, and/or GxP auditing.

Ot h e r Job R equ i r e men t s

  • Domestic and international travel may be required per business need.

  • Must have a global mindset.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

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.