The QA Program Lead is responsible for ensuring compliance with BioCryst’s Quality Systems for all outsourced and internal Good Manufacturing Practices (GMP) activities in support of small and large molecule drug substance and drug product manufacturing/packaging and testing performed at Contract Manufacturing Organizations (CMOs). The incumbent will serve as the QA product representative and single point of contact for project teams and will provide oversight for all current Good Manufacturing Practices (cGMP) governed aspects of the product life cycle based upon phase appropriate requirements. This includes early development and transfer of GMP processes to support clinical manufacturing and testing, scale-up and validation of manufacturing processes and test methodologies, CMC regulatory filing activities, and clinical/commercial release of drug product. Due to the nature of this role, the ideal candidate must be able to work cross functionally across multiple areas of the organization including R&D, QA&C, Clinical Development, Regulatory, Safety, Supply Chain, and Finance. Must routinely collaborate and directly communicate with contract facilities. Making onsite visits to assure ongoing regulatory compliance is critical for success. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Provides QA oversight and support for deviations, OOS/OOT investigations, change control, document control, training, validation, internal audits, vendor management, Cell Bank, API/Drug Substance, and Drug Product manufacturing and testing, packaging and labeling of drug product, and testing of drug substance and product for clinical and commercial distribution as well as stability.
• 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.
• Serves as Quality Lead in internal and external project team meetings and the single point of contact for Quality for commercial product to assure timely and consistent support of CMC regarding operational and supply chain needs.
• 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.
• 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 and provides quality guidance including but not limited to analytical/stability data, deviations, OOS investigations, change controls, master batch records and executed records associated for cell banking, drug substance/API, drug product, packaging, and labeling. Conducts, reviews and/or approves deviations/investigations providing guidance identifying potential product impact and determination of final product disposition.
• Conducts disposition of master and working cell banks, bulk drug substance/API, bulk and filled drug product and packaged/labeled drug product for clinical and commercial distribution. Performs disposition of material received at 3PL warehouse (Starting Materials, Drug Substance, and/or Finished Goods).
• Ensures all aspects of Quality Management at cGMP external vendors are carried out according with market cGMP regulations, local regulatory requirements, and BioCryst expectations for Drug Substance, Drug Product, and Packaging/Labeling, in a phase appropriate approach.
• Acts as the Quality subject-matter expert (SME), reviewer, approver for change controls. Initiates and manages external change controls, when necessary, based on vendor notification and BioCryst actions required.
• 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.
• 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.
• Revises and reviews SOPs and Quality Assurance (QA) procedures.
• Assists with preparation and performance of internal audits related to systems, documents and functions.
• Assists with the preparation, coordination, and management of regulatory agency inspections; Supports CMO regulatory inspections as needed.
• Supports development of training materials and conducts training.
• Ensures data is recorded in support of quality metrics for Quality Council and Quality Management Review. Develops, tracks, and trends cGMP metrics for reporting, review, and mitigation of risk at the Quality Council, and Quality Management Review Meetings.
• Reviews and revises Quality Agreements with vendors as needed.
• Coordinates on time completion of Annual Product Quality Review (APQR) and BioCryst Product Review (BPR) processes per established schedules. Collaborates with CMOs to assure timelines are met.
• Assists with complaint investigations for internally produced clinical and commercial products.
• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor’s degree with a minimum of eight (8) years of pharmaceutical experience in QA Operations, Manufacturing, Quality Control, and/or other relevant operational areas or the equivalent combination of education and experience.
• Experience working in a pharmaceutical industry producing both small and large molecules is preferred. Knowledge of manufacturing processes is required. Aseptic knowledge and experience preferred.
• Experience in early phases of drug development, from non-clinical toxicology studies to registration and process validation.
• Ability to drive initiatives and engage in pharmaceutical CMO relationships and oversight to ensure program and business objectives are met with no interruption to business.
• Experience leading and assisting in vendor and internal audits preferred; ASQ Certification preferred.
• Thorough understanding and application 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 the identification and development of resolution of GMP quality and compliance issues. Experience in providing leadership in cross-functional collaboration to drive efficient quality decisions.
• Proficient in using and navigating Quality Management Systems (QMS) such as Veeva. Expert knowledge and experience using QMS for deviations, investigations, change control, CAPA, and risk management.
• Comprehensive knowledge of root cause analysis techniques to support manufacturing and/or analytical investigations, CAPA, and risk evaluations. Ability to facilitate root cause analysis and risk assessments.
• Extensive knowledge and experience 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, protocols, deviations, and stability data.
• Must be a team player committed to quality, a motivated self-starter who takes initiative, detail and results oriented, well organized, and efficient. Works as part of a team as well as independently in a remote workforce environment. Taking on a leadership role as needed.
• Strong written and oral communication skills; ability to manage multiple projects at one time. Prioritizing as necessary to assure timelines and objectives are met.
• Ability to recognize when issues require escalation based upon potential risk to product, systems, or processes.
• Must be capable and willing to travel (up to 10%) domestically and internationally and ability to be on site as needed and/or requested.