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Director of Quality, External Manufacturing

Company: BIOCRYST PHAMACEUTICALS
Location: Durham
Posted on: September 13, 2020

Job Description:

Durham, NC 27703

Director of Quality, External Manufacturing. BIOCRYST PHAMACEUTICALS. -. COMPANY:. BioCryst Pharmaceuticals discovers novel, oral, small-molecule medicines that treat rare diseases in which significant unmet medical needs exist and an enzyme plays a key role in the biological pathway of the disease. BioCryst has several ongoing development programs including Orladeyo™ (berotralstat), an oral treatment for hereditary angioedema, BCX9930, an oral Factor D inhibitor for the treatment of complement-mediated diseases, galidesivir, a potential treatment for COVID-19, Marburg virus disease and Yellow Fever, and BCX9250, an oral ALK-2 inhibitor for the treatment of fibrodysplasia ossificans progressiva. RAPIVAB® (peramivir injection), a viral neuraminidase inhibitor for the treatment of influenza, is BioCryst’s first approved product and has received regulatory approval in the U.S., Canada, Australia, Japan, Taiwan, Korea and the European Union. Post-marketing commitments for RAPIVAB are ongoing. For more information, please visit the company’s website.. JOB SUMMARY:. The Director of Quality, External Manufacturing will be responsible for quality oversight of all contracted GMP vendors utilized in the development, manufacture, testing, release, storage, and distribution of clinical and commercial drug products for BioCryst. This role ensures appropriate oversight of external global vendors, assessment and mitigation of risk to quality practices and supply and assures all aspects of the quality relationship to ensure compliance (for early phase development products through commercial products).. This role reports directly to the Head of Quality but 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.. ESSENTIAL DUTIES & RESPONSIBILITIES:. Ensures all aspects of Quality Management at GMP external vendors are carried out according to cGxP regulations, local regulatory requirements, and BioCryst expectations in a phase appropriate approach.. Regularly collects, reports, and assesses vendor quality KPI’s, metrics, process performance indicators and quality system signals for adequacy of performance during periodic vendor performance management reviews.. Manages and supports the resolution of quality and technical problems identified at GMP external vendors in alignment with global standards and ensures that the all-critical and major issues, which may have an adverse effect on the quality of the product, are escalated to management and are resolved within stated timelines.. Assesses and supports Internal and External GMP vendor readiness for Health Authority inspections (PAI, routine, directed, other).. Ensures that GMP follow up actions in response to HA inspections or BioCryst audit observations are appropriately actioned and tracked to closure.. Provides input into the organizational Quality budget.. Provides quality oversight, support, and resourcing where applicable for key external GMP projects (product transfers, launches, due-diligence, other) to ensure compliance with the BioCryst Quality Management System, and facilitates issue escalation and resolution.. Supports deployment of operational excellence strategies internally and at external GMP vendors.. Supports Annual Product Review/Periodic Quality Review for commercial products by collecting and analyzing data provided by external GMP vendors.. Works closely with Development, Manufacturing and Supply Chain partners to assure business and quality objectives are achieved at sites and that a business partnership culture is maintained with Quality and other cross-functional partners.. Works closely with Quality Vendor Management to ensure appropriate quality oversight and problem resolution for external GMP vendors utilizing a risk-based approach.. Works with Quality Vendor Management to ensure that all external GMP vendors have been appropriately qualified, including participation in and/or review of external vendor audits and review, approval, maintenance and assurance of ongoing compliance to Quality Assurance Agreements.. Identifies quality improvements to BioCryst Quality Systems to maintain compliance and improve efficiency utilizing risk-based methodologies.. Recruits and develops talent to sustain local and global competitiveness.. Leads the QA team responsible for all development, clinical and commercial batch review activities (including ongoing stability protocol/data review, reference standard qualification, etc…) and provides guidance on final batch release decisions. Chairs the Material Review Board to ensure disposition of non-conforming materials.. Develops QA Batch Release Team training curriculum, ensures team is trained, and provides mentoring to the team.. Develops and oversees new hire and annual GMP training for GMP staff within the organization.. Develops appropriate procedures and process and provides support for method transfer and validation activities to provide QA review and oversight.. Represents QA at cross-functional project team meetings.. Provides support and contributes to other Quality Assurance activities as assigned.. EXPERIENCE & QUALIFICATIONS:. Minimum BS Degree in a scientific area.. Master of Science (Chemistry, Biology or Pharmacy) or Engineering (Chemical or Process) preferred.. Minimum of ten (10) years of pharmaceutical experience in QA Operations, Manufacturing, QC and/or other relevant operational areas, but must also minimally include seven (7) years in QA, and at least five (5) years of personnel management experience and early phase development, clinical, and commercial experience.. Demonstrated change, people and technical leadership experience.. Demonstrated technical experience in the pharmaceutical industry, with direct experience with early phase development, clinical and commercial API, Drug Product, and Finished Pharmaceutical manufacturing, testing, release, storage, and distribution processes for products in various dosage forms (sterile injectables and oral dosage forms).. Thorough knowledge of global cGMP and regulatory requirements for clinical and commercial operations for API and Drug Products.. Strong understanding and ability to implement risk management fundamentals/tools.. Excellent communication, negotiation, and presentation skills; maintains high ethical standards, and enjoys working with people and information, making decisions, problem solving, making a difference and working in a leadership role.. Excellent organizational skills and ability to work on multiple projects with competitive timelines.. Strong attention to detail and respect for the need of accuracy of information.. Must be capable and willing to travel (up to 25%), including the potential for international travel.. Advanced software skills (e.g., Microsoft Excel, PowerPoint, Microsoft Project).. Demonstrated ability to work effectively in a cross functional team environment and independently in a remote work setting, as necessary.. Excellent problem-solving and decision-making skills.. 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, 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 law.. BIOCRYST PHAMACEUTICALS - 2 days ago - save job. If you require alternative methods of application or screening, you must approach the employer directly to request this as Indeed is not responsible for the employer's application process.. Get job updates from BIOCRYST PHAMACEUTICALS. Thousands of employers search for candidates on Indeed

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