KBI BioPharma
Senior Manager Quality Assurance
KBI BioPharma, Durham, North Carolina, United States, 27703
Position Summary:
This individual will provide QA oversight of the Deviations, CAPA and Complaints organization. The Sr. Manager and works closely with the Program Management team to facilitate communications between KBI and clients regarding quality-related events. The role will develop and maintain the Quality Assurance staff by recruiting, training, and managing team member.
Position Requirements:Functions as the system owner for the Deviation, CAPA, and Complaint Quality systems.Track, trend, compile, and report quality metrics as required.Provides compliant investigations and review and approve investigations and corrective/preventative actions as needed.Develop and/or support training materials for Quality Systems to include Deviation/CAPA system and batch record review.Provide training and certification of QA personnel.Provides coaching and mentoring to direct reports and QA specialists.Support Client Audits and Regulatory Inspections as required.Partners with Program Management, Technical Operations, and AFS, and Manufacturing to provide support.Communicates with clients, as needed, regarding quality related events.Experience:
Required Education, BSRequired Experience 10+ years experience in QA or cGMP environmentExperience in providing QA support of Quality Systems to include Deviations, CAPAs and Complaints4+ Years of supervisory experienceDemonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.Strong understanding of FDA, EU and ROW cGMP regulations is required.
Salary Expectation: 130,000 - 160,000K
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, 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. 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.
This individual will provide QA oversight of the Deviations, CAPA and Complaints organization. The Sr. Manager and works closely with the Program Management team to facilitate communications between KBI and clients regarding quality-related events. The role will develop and maintain the Quality Assurance staff by recruiting, training, and managing team member.
Position Requirements:Functions as the system owner for the Deviation, CAPA, and Complaint Quality systems.Track, trend, compile, and report quality metrics as required.Provides compliant investigations and review and approve investigations and corrective/preventative actions as needed.Develop and/or support training materials for Quality Systems to include Deviation/CAPA system and batch record review.Provide training and certification of QA personnel.Provides coaching and mentoring to direct reports and QA specialists.Support Client Audits and Regulatory Inspections as required.Partners with Program Management, Technical Operations, and AFS, and Manufacturing to provide support.Communicates with clients, as needed, regarding quality related events.Experience:
Required Education, BSRequired Experience 10+ years experience in QA or cGMP environmentExperience in providing QA support of Quality Systems to include Deviations, CAPAs and Complaints4+ Years of supervisory experienceDemonstrated strong interpersonal skills, ability to work in a team environment, attention to details and excellent problem resolutions skills.Strong understanding of FDA, EU and ROW cGMP regulations is required.
Salary Expectation: 130,000 - 160,000K
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, 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. 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.