Sr. QA Specialist

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram.

JOB SUMMARY:

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). This position is responsible for ensuring compliance with BioCryst SOPs and policies for all outsourced and internal GMP activities. The incumbent 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, cell bank manufacturing, bulk drug substance and drug product manufacturing, packaging, and labeling of drug product, and testing of drug substance and product for clinical and commercial distribution. Due to the nature of this role, the ideal candidate must be able to work cross functionally across multiple areas of the organization such Research & Development, Quality Assurance & Control, Clinical Development, Manufacturing Science and Technology (MS&T), 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.
• Acts in the capacity of Quality Lead in internal and external project team meetings.
• 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 by 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.
• Acts as Quality SME, reviewer/approver for change controls. Initiates and manages external change controls when necessary, based on vendor notification and BioCryst actions required. 
• Conducts disposition of master and working cell banks, bulk drug substance, drug product and packaged/labeled product for clinical and commercial distribution. Performs disposition of material received at 3PL warehouse (Starting Materials, Drug Substance, and/or Finished Goods).
• Provides Quality guidance in the resolution of deviations, investigations, and out-of-specification events. Conducts, reviews and/or approves deviations/investigations.
• Works to create an environment of open communication, participation, and information-sharing within and between teams within Quality Assurance and across functional areas assuring the highest levels of quality, compliance, and integrity.
• Collaborates with internal cross-functional teams such as analytical development, technical development, MS&T, Supply Chain, CMC and Regulatory. Identifies potential systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation. Escalate issues of critical non-compliance and/or lack of urgency in remediation to Quality management. 
• Participates in qualification of Contract Manufacturing Organizations (CMOs) and monitoring their performance. Assists with vendor audits as needed.
• Communicates with CMOs, service providers, marketing authorization holders, and regulatory authorities verbally and in writing on a regular basis.
• Ensuring data is recorded in support of quality metrics for Quality Council and Quality Management Review.
• Writes and reviews SOPs and Quality Assurance (QA) procedures.
• Assists and serves as back-up for product quality complaints.
• Oversee training activities and prepares documentation. Presents/participates in GMP training sessions.
• Assists in hosting audits and regulatory inspections, assists with preparation and performance of internal audits.
• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor’s degree with a minimum of eight (8) years of pharmaceutical experience in clinical/commercial QA Manufacturing Operations.
• Knowledge of Oral Solid Dose and Steriles manufacturing processes is required.
• Experience in working in a pharmaceutical industry producing small and large molecules is preferred.
• Extensive knowledge of US and European Drug Substance, Drug Product, Finished Labeled 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.
• Must have a thorough understanding of pharmaceutical CMO relationships and oversight is a must.
• Ability to independently drive initiatives to ensure program and business objectives are met with no interruption to business or patient supply. 
• Experience performing vendor and internal audits; ASQ Certification preferred.
• Experience in the identification and resolution of GMP quality and compliance issues.
• Proficient in using and navigating Quality Management Systems (QMS) such as Veeva.
• Extensive knowledge and experience using QMS for 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 conducting impact assessments for quality and compliance purposes.
• Excellent attention to detail; experience with QA review of batch records, analytical data, method development and process development protocols, deviations, and stability data.
• Must be a team player committed to quality, a motivated self-starter; detail and results oriented, well organized, and efficient.
• Ability to recognize when issues require escalation based upon potential risk to product, systems, or processes. Strong written and oral communication skills; ability to manage multiple projects at one time.
• Works as part of a team as well as independently in a remote workforce environment, taking on a leadership role as needed. 
• Must be capable and willing to travel (up to 10%) domestically and internationally and ability to be on site as needed and/or requested. 

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.