The Sr. Quality Assurance (QA) Specialist is responsible for ensuring compliance with BioCryst’s Quality Systems in support of small and large molecule drug substance and drug product manufacturing/packaging and testing performed at Contract Manufacturing Organizations (CMOs). The Sr. QA Specialist will be responsible for ensuring compliance with BioCryst SOPs and Policies for all outsourced and internal GMP activities. The Sr. QA Specialist will coordinate and execute the batch review process with internal reviewers to ensure compliance to cGMP. Functions include QA oversight and support for deviations, OOS/OOT investigations, change control, document control, training, validation, internal audits, vendor management, stability program, API receipt and control, cell bank manufacturing, bulk drug substance and drug product manufacturing, packaging and labeling of drug product, and testing of drug substance and drug product for clinical and commercial distribution.  This role has high visibility throughout the organization and therefore requires close coordination across multiple groups with-in BioCryst, e.g., Pharmaceutical Development, QA, QC, Clinical, Regulatory, Safety, Supply Chain and Finance. #LI-Remote

ESSENTIAL DUTIES & 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 for both small and large molecule development and commercialization.
• Participates in internal and external project team meetings as the Quality Lead.
• Reviews internal developmental study protocols and reports. Reviews process validation protocols and reports including analytical test results to ensure compliance with approved specifications. Ensures studies, qualifications, and validations are performed per the protocol.
• Reviews cGMP documentation, including, but not limited to analytical/stability data, deviations, OOS investigations, change controls, master batch records and executed records associated with cell banking, drug substance (API), drug product, packaging, and labeling.
• Disposition of master and working cell banks, bulk drug substance, drug product and packaged/labeled product for clinical and commercial distribution. Aseptic knowledge and experience preferred.
• Provides Quality guidance in the resolution of deviations, investigations, and out-of-specification events. Conducts, reviews and/or approves deviations/investigations.
• Participates in qualification of CMOs and monitoring of CMO’s performance. Assists with vendor audits as needed.
• Communicates, written and verbal, with CMOs, service providers, marketing authorization holders, and regulatory authorities.
• Writes and reviews SOPs and Quality Assurance procedures.
• Oversees training activities and prepares training documentation. Presents/participates in GMP/GLP training sessions.
• Assists in hosting audits and regulatory inspections, assists with preparation and performance of internal audits.

EXPERIENCE & QUALIFICATIONS:

• Minimum of bachelor’s degree required.
• Minimum of five (5) years of pharmaceutical experience in QA Operations, Manufacturing, QC and/or other relevant operational areas required. Knowledge of manufacturing processes is required. Small and large molecule experience preferred.
• Extensive knowledge of US and European Drug Substance and Drug Product GMP requirements and associated guidelines for small and large molecule manufacturing, testing, and distribution.
• Experience in early phases of drug development, from non-clinical toxicology studies to registration and process validation.
• Experience in implementation and administration of quality systems for drug substance and drug product development, manufacturing, and quality control operations from early phase to commercialization.
• Understanding of pharmaceutical CMO relationships and oversight. Experience performing vendor and internal audits preferred.
• Experience in the identification and resolution of GMP quality and compliance issues.
• Proficient with the use of electronic systems for Quality Management Systems.
• Extensive knowledge and experience with Quality Systems such as Deviations, Investigations, Change Control, CAPA, and Risk Management.
• Knowledge of Root Cause Analysis Techniques to support manufacturing and/or analytical investigations, CAPA, and Risk Evaluations.
• Knowledge of the Change Management process, including conduct of impact assessments for quality and compliance.
• Excellent attention to detail; experience with QA review of batch records, analytical data, method development and process development protocols, deviations, stability data.
• 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.

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.

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, Veteran’s 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 law.