Quality Assurance Senior Manager

3 weeks ago

Durham, North Carolina, United States KBI BioPharma Full time
Job Summary:

This Senior Manager Quality Assurance position is responsible for providing QA oversight of the Deviations, CAPA, and Complaints organization. The role will work closely with the Program Management team to facilitate communications between KBI and clients regarding quality-related events. Additionally, the Senior Manager will develop and maintain the Quality Assurance staff by recruiting, training, and managing team members.

Key Responsibilities:
1. Functions as the system owner for the Deviation, CAPA, and Complaint Quality systems.
2. Tracks, trends, compiles, and reports quality metrics as required.
3. Provides compliant investigations and reviews and approves investigations and corrective/preventative actions as needed.
4. Develops and/or supports training materials for Quality Systems to include Deviation/CAPA system and batch record review.
5. Provides training and certification of QA personnel.
6. Offers coaching and mentoring to direct reports and QA specialists.
7. Supports Client Audits and Regulatory Inspections as required.
8. Partners with Program Management, Technical Operations, and AFS, and Manufacturing to provide support.
9. Communicates with clients, as needed, regarding quality-related events.

Requirements:
1. Required Education, BS
2. Required Experience 10+ years experience in QA or cGMP environment
3. Experience in providing QA support of Quality Systems to include Deviations, CAPAs, and Complaints
4. 4+ Years of supervisory experience
5. Demonstrated strong interpersonal skills, ability to work in a team environment, attention to detail, and excellent problem resolution skills.
6. Strong understanding of FDA, EU, and ROW cGMP regulations is required.

Salary Expectation: $130,000K

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, Sabbatical program, 401K matching with 100% vesting in 60 days, and employee recognition programs.

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. 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.

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