Shire Research Compliance Leader in Lexington, Massachusetts
Responsible for supporting Head of Research Compliance to oversee the compliance function in support of all Research programs / projects in R&D.
Principal responsibilities include:
Provides professional expertise, guidance and strong leadership in Good Laboratory Practices (GLP) and other applicable regulatory requirements (e.g. CAP, CLIA) to proactively identify compliance issues/risks in all Nonclinical, analytical and Bioanalytical studies within the organization and its external partners (as applicable).
Liaise with various internal groups and external groups including Contract Research Organizations (CROs), regulatory bodies, expert consultants and vendors, to maintain a high level of quality and consistency across the programs / projects in Research.
Fosters relationships with R&D staff to encourage discussion and evaluation of best practices for continuous improvement of quality and compliance across programs.
Perform study/project specific and program/process audits in support of GLP activities (as applicable)
Update and maintain required Research QA & Compliance Audit program (internal and external)and related documentation
Manage the development, implementation and maintenance of the Quality Assurance programs and activities in a regulated environment to ensure compliance with federal/state and country regulations (as applicable)
Provide guidance to Research & Development Management in preparation for regulatory inspections
Serve as key company representative during agency inspection, interface and host inspections, develop positive working relationships and ensure that compliance objectives are met.
Develop and/or review all responses to regulatory agency inspections and corrective action commitments, ensure that timely responses are generated.
Ensure Quality Assurance oversight and involvement in Computer Validation Projects supporting Research activities
Continuous Improvement & Procedural Documentation
Ensure that appropriate training is provided to staff as well as GLP and OECD GLP (as applicable) training to all Research personnel
Conduct focused training as necessary
Establish and maintain a periodic review system to assure compliance with Procedural Documents and GLP regulations
Direct and administer programs for measuring compliance by establishing metrics on critical quality endpoints and provide periodic reports to management with recommendations for continuous quality improvements
R&D Quality Operations Leadership
Ensure that objectives of the Research QA & Compliance are defined and communicated to cross-functional groups
Participate in R&D QA & Compliance projects having impact across all of R&D
Education and Experience Requirements
Bachelor’s degree (or equivalent combination of education and experience) in a life science 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, GLP auditing and at least 7 years of direct management experience.
Other Job Requirements
10-20 % Domestic and international travel required. Must travel globally to locations where nonclinical and bioanalytical activities exist. Must have a global mindset.
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.
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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
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.