Quality Assurance Manager / Sr. Manager - Deviations and CAPAs

Position Summary:

The QA Manager/Sr. Manager manages a team of QA Specialists and the process for the QA oversight of Deviations and CAPAs. This team performs daily deviation triage (classification) and investigation review/approval. The team is also responsible for QA oversight of the CAPA program for the site.

This position will lead qualified trainers to provide training delivery on the Deviation and CAPA process for the site, 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. This role will serve as the site representative and collaborate with the Global QA Compliance team as well as other sites on program revisions to the guiding SOPs and training materials for the Deviations and CAPAs program.

In addition, this role will serve as the primary contact for client communication and support for Deviations and CAPAs. This position is fully site-based (not remote) reports into the Director of Quality Systems.

Position 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 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 Engineering/Supply Chain) 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 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.

Minimum Requirements:

• Bachelor’s degree in pharmaceutical science, biology, chemistry, or related science. Minimum 5 years of leadership experience in pharmaceutical, Biological, Quality Assurance

• Requires thorough knowledge of GMP guidelines as they relate to quality systems and compliance.

• 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.

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.