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.

Position Summary:

The Quality Systems team is responsible for establishing and continuously improving the Quality Management System (QMS) that supports the site and Global Compliance activities for the site. Quality Systems collaborates with the site teams to build a culture of ongoing regulatory readiness and sustained compliance that delivers safe, pure and effect material to our clinical and commercial clients. The Senior Quality Assurance Specialist – Compliance is a key individual contributor to the team’s focus on ensuring systems and business processes are robust, effective, and efficient to comply with required regulations, policies, standards, and guidelines governing the manufacture and holding of materials for our company.

This role is an onsite hybrid role, working a schedule Monday through Friday between the hours of 8:00 am – 5:00 pm

Responsibilities:

• Serve as Quality lead for site Inspection Readiness activities, collaborating with all departments build a culture of regulatory adherence and Inspection readiness at all times.
• Works with the Operations teams to continuously improvement of procedures and process controls.
• Support Global Compliance as site host for Internal Audits, Client Audits and Regulatory / HA Inspections or other capacities as needed.
• Supports the Internal Audit program, serving as site point of contact and Quality lead for all Internal Audits
• Coordinates discussions and corroborates with site SMEs to develop robust solutions and deliver comprehensive responses to client Audit observations, meeting tight timelines to assure OTIF submissions
• Assists with coordination of activities and compilation of data to complete Annual Product Quality Reports (APQR).
• Supports the Quality Risk Management program. Performs trending and routine monitoring proactively to identify potential compliance gaps and improvement needs.
• Reviews / Approves Continued Process Verification (CPV) reports.
• Conduct nonconformance investigations and write/review final reports, such as Deviations, Product Complaints and Supplier Complaints. Collaborates with Operations and Quality teams to identify and implement effective CAPAs. Monitors effectiveness and expected impact on Compliance Metrics.
• Establishes, Writes, and revises Standard Operating Procedures.
• Assists with Quality related Training.

Requirements:

• 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.
• Minimum 7 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance, and Quality Operations including solid knowledge of global GMP Quality and Regulatory requirements.
• Minimum 5 Years experience in an FDA regulated Manufacturing (i.e., CDMO/CMO) facility
• Prior experience managing audits or internal inspection or participating in hosting and / or back-room capacity in a pharmaceutical environment
• Experience with Nonconformance reports: Deviations, Product Complaints, CAPAs
• Demonstrate sound leadership
• Ability to work professionally with others and facilitate positive interdepartmental interactions with a diverse group of people. Includes ability to navigate conflict to achieve deliverables and drive to targeted outcomes, as well as to resolve differing perspectives with effective negotiation.
• Demonstrate strong attention to detail and effective investigation, problem solving, and organizational skills. Ability to properly prioritize tasks and manage time effectively. Proactive approach to drive tasks to completion.
• Excellent written and verbal communication skills.
• Ability to read, write, and proofread technical documents, investigations, regulatory documents, etc.
• Ability to compile and analyze data and information from multiple sources
• Ability to perform basic calculations and data assessment, simple statistics, graphing, plotting data
• Minimum intermediate proficiency with of Microsoft Office Excel, Word, PowerPoint (Microsoft365).
• Intermediate proficiency with ERP and QMS systems required, such as SAP, TrackWise, and LIMS p
• Ability to sit for extended periods of time.
• Ability to work on site in a manufacturing environment periodically.

Salary Range:

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, and employee recognition programs.

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.

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.

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.