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Form of work Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead-guided by our core values, we'll meet these challenges. Join us!
The primary role of this position will be to assist the global quality function and to develop and implement the appropriate quality oversight, timely review and resolution of issues, and early intervention to assure appropriate cGMP/GLP compliance. This position will also be responsible for overall Supplier Quality Management, product disposition, internal and external deviation and CAPA management. This position reports directly to the Senior Director, Quality.
Essential/ Primary Duties, Functions, and Responsibilities
Supplier Quality Management
Manage and maintain Alpine's Supplier Quality Management program
Schedule, prepare, and conduct audits in support of GMP/GLP activities including agendas, responses, reports, and audit closure.
Perform internal audits in accordance with standard operating procedures and quality policies.
Manage post-audit activities and follow up on any vital corrective and preventive actions.
Maintain quality agreements and contacts with critical suppliers, professional organizations, consultants and colleagues in order to remain current with industry standards.
General Quality Oversight
Review method transfer, qualification, validation protocols and reports involving analytical methods for raw materials, in-process, drug substance and drug product release, characterization, and stability testing for biological drug candidates including reviewing data and resolving issues.
Ensure products are released in a timely manner in compliance with company procedures and regulatory requirements.
Work with internal cross functional teams to resolve issues and identify corrective actions.
Review and approve internal deviations, CAPA, and change controls. Monitor responsible open quality system records to closure.
Review cGMP Controlled Documents such as master batch production records, test methods, specifications and manage implementation of required changes to meet cGMP and internal standards. Communicate and resolve discrepancies.
Compile or assist with managing lot files.
Write and/or implement changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met.
Assist in the compliance for personnel qualification, training, procedures and processes and drive continuous improvement of the quality management system.
Assist with the reporting and/or presentation of department metrics.
Other duties as requested.
Education and Competency Requirements
A BS or MS in the physical or biological sciences with 12+ years of experience in Quality Assurance functions in support of biologic drug development projects
Established knowledge of global regulations and standards and experience in managing regulatory inspections and their application through the stages of product development to commercial readiness
Experience with overseeing relationships with existing and new CROs/CDMOs
In depth knowledge and experience with quality systems, corrective action and preventative action system, risk management, FMEA and other key tools for managing quality performance
Knowledge and experience with US/EU GMPs, ICH, and other applicable international regulations preferred
Work independently and exercise appropriate judgment
Demonstrated capabilities and proven track record of problem-solving during drug development in a dynamic work environment
Must have experience in reviewing sections for regulatory submissions.
Experience with quality management systems (QMS) and electronic documentation management systems (EDMS) required; implementation experience a plus
Proficiency in Microsoft Word, Excel, Smartsheet, and SharePoint
Must have the ability to communicate effectively, make presentations, and write concise reports as required.
Highly motivated team player willing to contribute to a growing biotech organization
#LI-Hybrid
At Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a management-level position with a compensation range of $140,000 to $160,000 for Senior Manager and $160,000 to $180,000 for Associate Director. In order to be considered for a position, candidates must be located in one of the following five states: WA, CA, MA, NC, or OR. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employees' satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).
Alpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.
Our treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpine's culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.
Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
Our office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.
Exciting challenges lie ahead-guided by our core values, we'll meet these challenges. Join us!
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