Shire Sr. Quality Representative Global QCTS – Technical Oversight in Lexington, Massachusetts
Newly combined with Baxalta, Shire is now the leading global biotechnology company focused on serving people affected by rare diseases and highly specialized conditions. These diseases are often misunderstood, undiagnosed and life-threatening. Our 22,000 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.
At Shire, we are dedicated to expanding, building and sustaining leadership across our key therapeutic areas through our extensive portfolio of products, innovative pipeline and collaborative approach to working with diverse partners around the globe. We strive to earn and keep the trust of our patients, their families and physicians. Working together, the possibilities for our patients, healthcare partners and employees are unprecedented, with significant growth potential for our shareholders.
As team member of Global Quality Control technical support – technical oversight you would be responsible for:
Support and lead oversight of analytical method lifecycle during clinical and commercial stages from initial delivery through routine use, replacement and obsolescence
Design method validation strategy together with method experts
Review and approve method validation protocols
Support and oversee method transfer strategy and comparability testing
Approve method transfer plans and protocols
ensure analytical method validations are compliant to applicable internal and external guidelines and procedures
Review and approve investigations of method related laboratory exceptions. Define appropriate corrective actions together with investigation team.
act as SME and technical advisor in the field of method validation and calibration of reference standards
Act as a link between Global QC departments (method introduction, analytical lifecycle management)
Oversee centralized ownership of analytical methods through centralized control and distribution of harmonized procedures
Serve as technical SME for responsible programs during agency inspections
Conduct work in compliance with cGMPs, safety and regulatory requirements
Reviewing and supporting submissions as required
BA/BS in relevant scientific discipline with a minimum of 5 years relevant industry experience
Requires knowledge and proficiency in the design, execution, and validation of analytical techniques used in the laboratory such as HPLC, SDS-PAGE, Capillary Electrophoresis, Potency and Bioassays.
Ability to troubleshoot method performance and propose corrections is essential.
Background in analytics or natural sciences (university degree or similar)
Quality Control and method validation experience
Fluent in English and German
Excellent communication skills in a cross-cultural and cross-department environment
Excellent communication, interpersonal and organizational skills
Ability to work well both independently and in a team environment.
Ability to prioritize work and multitask
Project management experience would be a plus
Self-driven, highly motivated, cooperative and proactive
Organizational and problem solving skills
six sigma experience would be a plus
Project management experience would be a plus
Knowledge concerning cGMP (mainly QC related)
Willing to travel
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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, gender identity, 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.