Senior Manager, QA - 6-month mission

Job content

This is a temporary position of 6 month, the selected candidate will be hired externally via an agency.

Job Summary

Supports cGMP manufacturing operations for manufacture of clinical biopharmaceutical products in a contract manufacturing environment. Manages activities of the QA Batch Release and Deviations/CAPA organizations and facilitates communications between KBI and clients regarding product quality-related events. The Senior Manager interacts directly with clients and provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients.

Job Responsibilities:

• Provides overall direction to Quality Supervisors and Managers supporting master and executed batch record reviews/approvals for commercial programs, shop floor QA oversight, and the Deviation/CAPA system. Assures that department and company employees comply with required procedures.
• Provides coaching and mentoring to direct reports and QA specialists. Develops and/or supports training materials for Quality Systems including Deviations/CAPA system and batch record review. Provides training and certification of QA personnel.
• Level loads work across teams to ensure batch record, deviation and CAPA timelines are achieved in support of manufacturing batch release.
• Functions as the Deviation/CAPA quality system owner. Provides compliant investigations and reviews and approves investigations as needed. Provides compliant review and approval of master batch records and supporting records and procedures. Supports manufacturing change controls as QA Subject Matter Expert, performing supplemental impact assessments and QA approvals as required.
• Tracks, trends, compiles, and reports client specific quality metrics and internal quality metrics as required. Specific data may be reported out at client meetings and internal Management Review meetings. Supplies data for client specific Annual Product Reports as needed.
• Attends relevant operational meetings in support of Manufacturing operations and batch disposition activities. Supports client audits and regulatory inspections as required. Partners with Program Management, Manufacturing Science and Technology, Analytical and Formulation Services and Manufacturing Operations to provide QA support.
• Act as responsible delegate
  
  

Minimum Requirements

• Bachelor’s degree and 10+ years’ experience or Master’s degree and 8+ years’ experience or PhD and 6+ years’ experience in a QA or cGMP environment in Biopharmaceuticals or equivalent. Experience in providing QA support of Quality systems to include Deviations/CAPAs and Change Controls with 4+ years of supervisory experience. Demonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.
• Strong understanding of Swissmedic, EU and FDA regulations is required.
• Fluent in French and English
  
  

KBI Biopharma, Inc. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.

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.