QA Manager, External Biologics - Disposition

Employer
Location
Lexington, MA, USA
Salary
Competitive
Posted
Dec 05, 2017
Closes
Jan 05, 2018
Ref
2072304370
Contract Type
Full Time
Job Type
Lab Manager
**Primary Role**

Works in the External Biological QA team of Shire United States (US) Quality Assurance. This unit includes oversight of external drug product manufacturing at contract manufacturers, laboratory operations, internal warehouse operations, packing and labeling operations, batch release and logistics performed on behalf of Shire. This unit also provides QA support for Quality Control (drug substance, drug product testing and stability).

This individual will support all disposition activities related to external commercially manufactured medical device, drug substance, drug product and finished drug. The individual is responsible for achieving the functional area goals and objectives as they relate to individual and Shire goals.

Responsible for adhering to domestic and international GMP regulations, cGMP's, company policies, DNA leadership capabilities and BRAVE values. The position require approximately up to 15% travel.

**Responsibilities**

This position is responsible for review and release of all records associated with external manufacturing including drug substance, fill/ finish bulk product and finished drug product. Supports cold chain and evaluation of cold chain as related to movement of drug substance, drug product, and finished drug product to the end user.

The individual may be responsible for, but is not limited to:

+ Prepare and execute biologic drug product and finisheddrugproduct batch disposition in accordance with prioritiesandregulatorycommitments

+ Review of all quality systems: SOPs, specifications,executedbatch records, deviations, CAPAs and change controlsasrelated to disposition and coldchain

+ Review and approval of product specification and CertificateofAnalysis

+ Prepare drug product annual review reportsections

+ Understanding of GMP's; primary decision maker on issuesofmajor complexity and knows to raise issues ofadvancedcomplexityResponsible for continuous improvement on an ongoing basistomitigate current gaps

**Education & Experience Requirements**

+ Bachelor's degree in chemistry, biology or a relateddiscipline.

+ 8 years Quality Assurance experience supporting the manufacture and release ofcommercialdrugs, biologics or devices manufactured at CMOs

+ Knowledge of batch recordreview

+ Experience with authoring Drug Product Annual Product QualityReports

+ Good understanding of quality systems andcGMPs

+ TrackWise, LIMS and SAPexperience

+ Interpersonal skills and professional skills to interact withcustomers

+ Must beflexible

+ Must be able to prioritize and multitask in a stressfulenvironment

+ Fluency in English isrequired.

**Other Requirements**

Periodic domestic travel is required for business meetings with regional Quality team, corporate peers/collaborators, vendors/contractors, and to stay current with professional development opportunities

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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law - Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

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.