JOB SUMMARY:

• The QA Manager/Sr. Manager is responsible for managing a team of QA Specialists who are responsible for GMP compliance of Deviation and CAPA management. This team performs daily deviation triage (classification) and investigation review/approval. This team is also responsible for GMP compliance of the CAPA program.
• This position will lead qualified trainers to provide training delivery on the Deviation and CAPA process for the site and globally, as well as mentorship of QA Approvers on process proficiency.
• The QA Manager/Sr. Manager will provide direction and resolution to complex issues in investigations and CAPAs to investigator and action owners. In addition, this role will serve as the primary contact for client communication and support for Deviations and CAPAs. This position reports into the Associate Director of Quality Systems.

JOB RESPONSIBILITIES:

• Lead, assess, mentor, and develop departmental associates. Level load work across team to ensure timely closure of Quality Systems items in support of manufacturing and batch release timelines. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities. Coach QA Specialists and Investigators to achieve process proficiency for investigating and reviewing/approving deviations and CAPAs.
• Manage the Deviation/CAPA system for the site. Oversee QA review of Manufacturing, Facilities/Engineering Deviations (including Excursion reports) and CAPAs. Work directly with functional areas (Manufacturing/Facilities) to review and approve deviations. Report KPI’s and collaborate with functional areas to improve the Site Quality Systems and streamline processes.
• Coordinate client communications for deviations and CAPAs. Address client comments with internal SMEs and driving client approvals. Represent Quality in required client meetings, which includes obtaining client metrics and presenting in client meetings.
• Attend relevant operational meetings in support of Manufacturing Operations and disposition activities. Support Client Audits and Regulatory Inspections as required.
• Engage with global QA to support Site Quality Systems needs, achieve alignment and provide training support to other Sites as needed. Deliver training and coach qualified trainers on deviations and CAPAs processes.

REQUIREMENTS:

• Bachelor’s degree in pharmaceutical science, biology, chemistry, or related science. Minimum 5 years of work experience in pharmaceutical, Biological, Quality Assurance. Requires thorough knowledge of GMP guidelines as they relate to quality systems and compliance.
• Previous people management experience is required. Minimum 2 years for Manager level and 5+ years for Senior Manager level.
• Experience and knowledge of worldwide regulatory requirements with emphasis on regulatory requirements for biotechnology-derived product. Experience managing data, metrics, and presenting to senior management. Demonstrate strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem resolution sills.
• Demonstrated track record in the following key areas: - Strong orientation for Quality and Customer Service - Demonstrated level of respect for individuals - High level of integrity and personal responsibility - Record of innovation - Strong collaboration and team building skill
• This job requires on-site presence, cannot be staffed remotely and is not eligible for routine Work From Home accommodations.

Salary Range:

Manager: $118,000 - $162,800

Senior Manager: $133,000 - $183,700

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.

About KBI:

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.

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.

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.

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.