QA Site Compliance Lead
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POST DATE 9/10/2016
END DATE 10/20/2016
JOB DESCRIPTIONJob Description
This position is responsible for Lexington Site inspection readiness. The scope of this role includes inspection readiness at Lexington Site and satellite locations, for inspections and audits performed by Health Authorities and business partners.
This position will be responsible for hosting the inspections and identification, training and involvement of supporting roles depending on the scope of the inspection.
This position will be responsible for working with and influencing the Heads and Leads of Quality groups reporting to the QMR and with other site compliance leads within the Biologics Operating Unit. This leadership role is responsible for ensuring consistency of approach to inspections and for ensuring inspection readiness in Lex Site and associated satellite locations.
This leader will partner closely with other Technical Operations leaders especially groups reporting to the QMR, Business Process Owners, Validation, External Supply, Technical Support, OE, Regulatory and Supply Chain to ensure compliant and efficient quality systems to support inspection readiness.
Strong collaboration and the ability to effectively work in a matrixed environment are critical to success.
This position is responsible for Lex Site inspection readiness within Technical Operations according to Shire, GMP standards. This role sets direction and strategy to maintain inspection readiness at Lex Site and satellite locations.
The leader will set goals for the function that helps drive strategy execution to enhance and maintain Shires Quality operations globally in compliance with Shire global standards.
The leader is responsible for finding solutions to effectively navigate and correct misalignment between different stakeholders both within and outside the operating unit with a focus on overall inspection health of the Site.
Responsible for identifying primary roles (host/co-host) and support roles (backroom, gatekeeper, scribe, etc.) according to the inspection scope.
Responsible for inspection readiness activities including reporting and escalating inspection risks along with development and execution of mitigation actions focused on risk mitigation. This includes identification of interim controls and influencing stakeholders to drive timely action where mitigation is required.
Maintains and demonstrates inspection readiness and partners with OE to drive improvement to the inspection programs in alignment with Center Function.
Responsible for maintaining site licenses, renewals and paper inspections including holding department owners accountable for timely completion of requests in support of paper inspections.
Responsible for the Site Master File including working with responsible groups to complete updates in accordance with procedural requirements.
Responsible to manage and/or support APQR activities in partnership with Center Function.
Responsible for inspection responses within defined regulatory timelines and generation of the associated CAPA plans.
Responsible for managing and reporting on-site inspection readiness Quality metrics, aligned to TOLT metrics, and leading the effort to drive improvement.
Proactively identifies and drives remediation of risks within sphere of influence including but not limited to high-risk and regulatory CAPAs.
Responsible to facilitate hosting and responding to internal audits conducted within Lex Site and associated satellite locations.
Note: Percentage of time allocated to each area of responsibility will vary depending on the Site inspection and internal audit schedules year to year. In general, support will be divided as follows:
60% - Inspection and Audit Readiness and Associated Activities
25% - Paper Inspections and Site Master Files
15% - Annual Reports
Preparation and Approval of Inspection responses. These require additional approval by Head of
Biologics Operating Unit or delegate (Site QMR).
EDUCATION & EXPERIENCE REQUIREMENTS:
Minimum Bachelor s degree in pharmacy, chemistry, biology or a related discipline.
Minimum 7 years of experience working in a Quality role in the pharmaceutical or biotechnology industry.
Experience in the biotechnology and/or pharmaceutical industry, preferably both.
Thorough understanding of quality systems, cGMPs, GDPs.
Proven people manager and leader capable of developing people and teams
Track record of effective Quality leadership.
Experience leading, training and/or implementing root cause analysis and effective investigation practices.
Experience in interacting with health authorities including hosting/direct involvement with agency inspections.
High level of professional competence. Preferably demonstrated by objective certification (.e.g.Certified Quality Auditor).
OTHER JOB REQUIREMENTS:
Domestic and International Travel may be required. Depending on growth of organization and the primary
work location, travel is estimated to be
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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