Senior Vice President, Quality & Regulatory

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 :

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.

Requirements :

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 : $275,492 - $378,802 USD

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 .