<p>At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.</p> <p>Position Summary:</p> <p>Individual contributor and special project leader responsible for ensuring compliance with internal quality documents, regulatory requirements, and cGMP. The incumbent will serve as Quality-to-Quality client liaison and sometimes SME for the Quality team reporting cross-QA metrics and status for KBI and clients. The role is client-facing.</p> <p>The incumbent will be responsible for supporting processes required for product release, including deviation investigation guidance and CAPA review and approvals. Additionally, the incumbent will be responsible for compiling, analyzing, and reporting of associated Quality and Client metrics. The completion of the Annual Product Quality Review for commercial programs is also required.</p> <p>The role requires routine interactions with all functions supporting the external network, including interaction with functions across our company's global network.</p> <p>Responsibilities:</p> <ul> <li>This role is expected to be primarily on-site </li><li>Provides interface between KBI Quality and client regarding batch status, Quality metrics, and Quality issues impacting batch disposition and disposition timeline. </li><li>Communicates client concerns to KBI teams; facilitates discussions as necessary to resolve client issues. Escalates issues to leadership as needed. </li><li>Routinely interfaces with the PMO team to ensure any Quality topics are addressed. </li><li>Serves as QA facilitator for the Quality aspect of all projects requiring QA support. Serves as the accountable Quality lead, decision maker, and delegate for project teams and in related meetings. </li><li>Supports audit / inspection readiness of the site. Participates in regulatory and other quality and compliance report-outs; reviews client audit outcomes to ensure appropriate corrective actions are implemented as assigned. </li><li>Serves as client liaison and quality representative on behalf of KBI in audits, client and other client facing meetings and those requiring a Quality SME where the job skills and proficiencies allow. </li><li>Supports Deviation Management activities by participating in investigational meetings, activities, writing as needed, and approving investigations. </li><li>Leads Product and Client Complaint activities in accordance with SOP and established requirements. </li><li>Supports efforts to ensure organization operates within established policies/procedures and complies with all applicable governmental regulations (cGMP, etc.), both domestic and foreign. </li><li>Operates in a safe and efficient manner and in compliance with the safety and health policy. </li></ul> <p>Requirements:</p> <ul> <li>BS/BA Degree in Science or Engineering relevant to the pharmaceutical / Life Science or related industries AS/AA acceptable with 7-10 years of relevant experience as described below. </li><li>Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including solid knowledge of global GMP Quality and Regulatory requirements. </li><li>Minimum of 2 years of previous experience in QA and experience in a Client-Facing QA role. Project Management experience or formal training is a plus. </li><li>Demonstrates solid Body of Knowledge of Quality systems and functions supporting drug or related FDA governed manufacturing obtained from professional Quality roles. Includes a balance from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, Prior direct regulatory agency, and audit management / support experience a plus. </li><li>Ability to work effectively with others and communicate in customer-facing forums to progress issues and obtain positive results. Ability to navigate conflict to achieve deliverables and drive to targeted outcomes. Ability to resolve differing perspectives with effective negotiation. </li><li>Ability to work professionally and facilitate positive interdepartmental interactions with a diverse group of people. Voluntarily communicates needs and suggestions clearly and effectively. Listens and is attentive to others' ideas and contributions. </li><li>Demonstrated ability to keep Project Leads, such as PMs and team members, informed of the status of assigned work. Ability to determine where escalation is necessary. Capability of being flexible as required tasks change and maintain productivity. </li><li>Demonstrated ability to be a strong, dependable team-player, yet effective at advancing assignments and projects independently. </li><li>Demonstrated strong attention to detail and effective investigation, problem solving, and organizational skills. </li><li>Ability to properly prioritize tasks and manage time effectively. Positive proactive approach to drive projects/tasks to completion </li></ul> <p>Salary Range: $118,000 - $148,000</p> <p>Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.</p> <p>About KBI:</p> <p>KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.</p> <p>KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.</p> <p>KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.</p> <p>KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.</p> <p>I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.</p> <p>I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.</p>