Vice President of Quality Assurance

Company: Carolina Pharmaceutical Research
Location: Boulder
Posted on: April 8, 2021

Job Description:

Vice President of Quality Assurance


Direct Hire


Salary: 190K-$225K


Job Summary


Quality Site Head at a contract manufacturer of microbial fermentation protein therapeutics.


Duties:


Lead a Quality Assurance organization responsible for raw material inspection and release, QA on the floor, disposition of bulk drug substance, QA review of quality control data, and QA review of method validation, process validation, and equipment/utilities qualification. Quality Assurance organization is also responsible for internal auditing, supplier quality management, change management and document/records management, managing regulatory inspections, quality systems oversight and quality metrics reporting.


Oversight, development, implementation/ 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. 30 Lead, assess, coach, and develop departmental associates. Manage performance; ensure team meets expectations and meets objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.


25 Key contributor to long term strategic planning and part of senior leadership team. 25 Work with internal and client teams to establish Quality strategy, define roles and problem solve. 20


Qualifications and Education:


Experience: 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 Language Ability: Ability to read, analyze, and interpret the most complex documents.


Ability to respond effectively to the most sensitive inquiries or complaints. Ability to write speeches and articles using original or innovative techniques or style. Ability to make effective and persuasive speeches and presentations on controversial or complex topics to senior management peer group, employee groups, customers and/or the boards of directors. Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism formulas, scientific equations, graphs, musical notes, etc., in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. Math Ability: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Computer Skills: Word processing, Spreadsheets, Power Point, Internet, E-mail, Calendar Management Equipment Used: Computer, telephone


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Keywords: Carolina Pharmaceutical Research, Boulder , Vice President of Quality Assurance, Executive , Boulder, Colorado