Quality Assurance Manager - Birmingham, AL | Biospace
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Quality Assurance Manager

BioCryst Pharmaceuticals, Inc.

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Location:
Birmingham, AL
Posted Date:
8/30/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Manager, QA, Quality Assurance,

Job Description


JOB SUMMARY:

The Quality Assurance Manager at BioCryst Pharmaceuticals, Inc. is responsible for managing and overseeing compliance with BioCryst’s Quality Systems in support of drug substance and drug product manufacturing and testing performed at Contract Manufacturing Organizations (CMOs).  Reporting to the Director of Quality Assurance, the QA Manager will be based at BioCryst’s Birmingham, AL site and will be responsible for ensuring compliance with BioCryst SOPs and Policies for all outsourced and internal GMP activities. The QA Manager will coordinate and execute the batch review and release process with internal reviewers to ensure compliance to cGMP.  Functions include QA oversight and support for deviations, investigations, document control, training, validation, internal audits, vendor management, stability program, API receipt and control.  


ESSENTIAL DUTIES AND RESPONSIBILITIES:

•   Performs all responsibilities in accordance with US and European Drug Substance and Drug Product GMP regulations and associated guidelines, appropriate to the phase of development
•   Reviews drug substance and drug product master and executed manufacturing batch records from CMOs, including related documents such as specifications, analytical and microbiological methods and stability study protocols; communicates manufacturing deficiencies and non-conformances to vendor and works to ensure resolutions. Provides Quality guidance in the resolution of deviations, investigations, and out-of-specification issues (Root Cause, CAPA, Risk Evaluations).Reviews process validation protocols and reports
•   Reviews analytical test results to ensure compliance with approved specifications.  
•   Ensures studies, qualifications, and validations are performed per the protocol.
•   Reviews internal developmental study protocols and reports
•   Assists in updating regulatory and quality documents (INDs, IMPDs, Annual Reports)
•   Assists in hosting audits and regulatory inspections
•   Coordinates and performs internal audits
•   Participates in internal and external project team meetings
•   Supports Document Control function for site
•   Oversees training activities and prepare training documentation
•   Writes and reviews SOPs and Quality Assurance procedures
•   Participates in qualification of CMOs and monitoring of CMO’s performance.
•   Presents/participates in GMP/GLP training sessions

Requirements


REQUIRED EDUCATION/EXPERIENCE/SKILLS:

•   Bachelor’s degree or higher in science, mathematics, or engineering with at least of 10 years’ experience in a Quality Assurance role in the pharmaceutical industry
•   Experience with managing pharmaceutical CMOs
•   Extensive knowledge of US and European Drug Substance and Drug Product GMP requirements and associated guidelines
•   Experience in the identification and resolution of GMP quality and compliance issues.
•   Experience in implementation and administration of quality systems for drug substance and drug product development, manufacturing, and quality control operations from early phase.
•   Experience in early phases of drug development, from non-clinical toxicology studies to registration and process validation.
•   Experience performing vendor audits/internal audits

Technical Skills:

•   Extensive knowledge of US and European Drug Substance and Drug Product GMP requirements and associated guidelines
•   Team player committed to quality; motivated self-starter; detail and results oriented; well organized, efficient worker with good communication skills
•   Strong written and oral communication skills; ability to manage multiple projects at one time
•   Great attention to detail; experience with QA review of batch records, analytical data, method development protocols, deviations, stability data.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local laws.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification.  They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.