What are the responsibilities and job description for the Senior Vice President, Quality & Regulatory position at KBI Biopharma?
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.
Position Summary:
Responsible for Quality Assurance and Regulatory oversight at a global contract development and manufacturing organization specializing in biopharmaceutical-based products. Product types may be microbial fermentation, mammalian cell culture or human cell therapy derived. Lead Quality Assurance and Regulatory CMC senior management organizations across multiple sites, develop shared policies, procedures and systems governing the quality operations, quality compliance, regulatory compliance, and regulatory CMC support programs for the company. Responsible for company-wide oversight of budgets and stagging plans for quality assurance and regulatory CMC departments, regulatory inspection management, review of quality agreements and service agreements as needed.
Responsibilities:
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.
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.
Position Summary:
Responsible for Quality Assurance and Regulatory oversight at a global contract development and manufacturing organization specializing in biopharmaceutical-based products. Product types may be microbial fermentation, mammalian cell culture or human cell therapy derived. Lead Quality Assurance and Regulatory CMC senior management organizations across multiple sites, develop shared policies, procedures and systems governing the quality operations, quality compliance, regulatory compliance, and regulatory CMC support programs for the company. Responsible for company-wide oversight of budgets and stagging plans for quality assurance and regulatory CMC departments, regulatory inspection management, review of quality agreements and service agreements as needed.
Responsibilities:
- Oversight, development, implantation/improvement of quality systems, standards, and procedures for inspecting, testing, and evaluating manufactured product. Creates Quality Assurance policies and programs, Collaborates with other Quality Site Heads on continuous improvement initiatives.
- Lead, assess, mentor, and develop departmental associates. Manage performance; ensure team meets expectations and objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
- Key contributor to long term strategic planning and part of senior leadership team.
- Work with internal and client teams to establish Quality strategy, define roles and problem solve.
- Minimum requirement is a Bachelor of Science degree in a scientific discipline with 8 years of quality management experience. A Master’s degree with 6 years or a Doctorate degree with 4 years of quality experience would be considered.
- Additionally, at least 5 years’ experience serving in a relevant technical management capacity required. CMO experience preferred.
- Must have thorough knowledge of cGMPs and biotechnology-derived product regulations. Also requires a demonstrated track record in the following key areas:
- Regulatory Inspection management
- Strong orientation for Quality and Customer Service
- Strong Collaboration and team building skills
- Attainment of aggressive growth and profit objectives
- Demonstrated level of respect for individuals
- Demonstrated contribution to science in appropriate area
- High level of integrity and personal responsibility
- Record of innovation
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.
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.
Salary : $275,492 - $378,802
