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Shire QA-API Lead (Associate Director level) in Exton, Pennsylvania
The primary responsibility for this role is to provide Quality oversight of Active Pharmaceutical Ingredient (API) contract manufacturing organizations (CMOs), to provide strategic quality input to Shire project teams regarding API, and to support regulatory inspections. The qualified candidate will be able to perform independently across various Global Supply Chain functions to ensure supplier quality of API manufacturing and supplier sites.
On-going : Performs independently across various GSC functions to ensure supplier quality of API manufacturing and supplier sites. This includes maintaining strong operational insights and ability to influence complex organizations as needed to ensure quality operations and resolution of issues that could potentially impact product.
20%: Establish a close working relationship with Shire API suppliers thru supplier improvement programs, regulatory inspection support, GMP
10%: Identify, assess and resolve quality related issues that impact cGMP compliance, regulatory filings, or other risks to shire products.Track and evaluate any non-conformances that occur during the manufacture of cGMP material. Identify and prevent or resolve issues that could impact the continuity of supply of existing API products.Make decisions on the acceptability of product for release to market.
10%: Critically assess method and process validation protocols and reports for API.
10%: Provide appropriate leadership, management and development to direct reports, colleagues, and CMO personnel as applicable.
10%: Support and contributed to new business opportunities such as new product introduction, product launches, and product integration into Shire systems.
10%: Design action plans for remediation activities for product and/or quality systems. Communicate activities to CMO and Shire leadership as needed.
10%: Perform batch record, deviation, validation, change control, customer complaint processing and review as related to API manufacturing
10%: Maintain an up-to-date knowledge of the regulatory environment as it pertains to position responsibilities.
5%: Participate and conduct contractor audits to assure compliance to GMPs, regulatory filings (DMF, NDA, MAA, etc.)FDA, ,EMEA, ICH and other applicable regulatory guidelines
5%: Negotiate Quality Technical Agreements as needed
Education and Experience Requirements
B.S. in a scientific discipline
Minimum 10+ years of QA experience
Minimum 5 years of QA experience with some management responsibilities of personnel and in product release, validation, auditing investigation assessment.
Experienced in computer software
Strong analytical background required (some years spent in a lab environment), including method validation and OOS root cause analysis.
Experience in API manufacturing a must
Willingness to travel required
Other Job Requirements
Good global and cross-boundary communication skills both verbal and written
Strong risk assessment skills
Flexible and willing to travel with US and internationally
Able to build authentic relationships internally, with third party suppliers and with regulatory agencies
Ability to inspire and motivate others both within the department, cross functionally and at contract sites.
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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 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.