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Shire QA Specialist in Lexington, Massachusetts
Position is part of the Supply Chain Quality COE and NA Region team which is responsible for Supply Chain in North America (US and Canada) and is the Center of Excellence for Quality Oversight for Global Artwork & Labeling, Quality Systems, and Supply Chain (Shipping Qualification, cold chain, SAP, etc). Responsibilities for this position include:
The overall responsibility of this role is to support and execute the qualification of transportation of Shire products globally in accordance to Shire’s global standards.
The role is also responsible for supporting the replenishment activities within North America and shipments to other markets from North America for the purposes of Replenishment.
This role is responsible for the successful and timely completion of goals and objectives associated with Global expansion and launch strategy, real estate and supply chain strategy, integration of new business into Shire, and operations management as related to Shipping Qualification.
Responsible for establishment and continuous improvement of distribution and supply chain quality processes, driving for compliance and efficiency while allowing local flexibility.
Support additional initiatives and responsibilities for Center of Excellence including expertise in handling of temperature excursions, deviations, change control etc as required.
Ensure coordination with all regional functions (e.g. commercial, RA and Supply Chain), as well as Quality function heads to ensure seamless interaction, timeliness, and compliance of distribution of commercial products and regional expansions.
Ensure region metrics and trend reporting is performed that provides visibility to the on-going status of the responsibilities of this function.
Participant of Regional Leadership Teams as applicable.
Education and Experience Requirements
The ideal candidate will have the following education and experience:
Degree in technical discipline such as biochemistry, chemistry, engineering or equivalent pharmaceutical experience (20 years or more)
At least 5 – 10 years of experience in the biotechnology and/or pharmaceutical industry, preferably both.
Experience and/or knowledge with small and large molecule production processes, aseptic processing, as well as tableting and controlled substances is desired
Over sight of external partners (Contract Labs, CMO’s, or Distributors, etc.)
Experience and/or knowledge of Packaging and labelling
Experience and/or knowledge of Distribution
Strong operations background to ensure value added and effective quality operations.
Experience driving out inefficiencies and improving turnaround times
Understands regulations pertaining to licensing, import/export, scheduled/controlled drugs, and transportation requirements, in North America.
Working in a multinational organization effectively navigating differing regional expectations and regulations
Other Job Requirements
Domestic and International Travel will be required to facilitate robust partnerships and execution. Depending on growth of organization and the primary work location, travel is estimated to be approximately 10%.
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.
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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.