KBI Biopharma
Vice President, Quality Assurance
KBI Biopharma, Durham, North Carolina, United States, 27703
Job Summary:
Vice President of Quality, Quality Site Head at a contract manufacturer of microbial fermentation and/or mammalian cell culture protein therapeutics. Lead a Quality Assurance and Quality Control team which includes both QC Analytical and QC Microbiology. The individual in this role is recognized as a subject matter expert with regard to Quality Assurance and Quality Control.
Quality Assurance:
The Vice President of Quality, Quality Site Head is accountable for raw material release, Quality on the floor, disposition of drug substance, QA review of quality control data, root cause analysis, risk management, deviation, Change Control and CAPA management, document/records management, quality metrics reporting, data integrity, training management, QA review of method qualification/validation, process qualification/validation, and equipment/utilities/facilities qualification and continuous improvement. Partner with Global Quality in ensuring internal audits, client audits, supplier quality management, managing regulatory inspections, and quality systems are implemented effectively, efficiently, and compliantly at the site.
Quality Control:
The Vice President of Quality, Quality Site Head is accountable for QC Analytical and QC Microbiology. He/she is responsible for oversight of QC Analytical testing and QC Microbiology tasks including Bioburden, Endotoxin, TOC Conductivity, Water collection Osmolality, EM collection and testing, Organism/Media QC, EM Trending, Sample Accessioning, and Raw Material Program Management.
Proven skills in the knowledge of 21CFR210, 211 is also required. This role is key in collaborating with site operations (Manufacturing, Facilities & Engineering, Supply Chain, EHS&S, and Operational Excellence) to ensure appropriate quality oversight. Partnership with the Senior VP, Operations, and Site Head is crucial to ensure the site’s success.
In consultation with the SVP of Quality and Regulatory, the Vice President of Quality, Quality Site Head holds final accountability for and decision making on the matters relating to GMP compliance for the site.
Job Responsibilities:
Oversee and implement quality systems, standards, and procedures for inspecting, testing, and evaluating manufactured product. Ensure the site is inspection ready at all times. Collaborates with other Quality Site Heads on continuous improvement initiatives.
Lead, assess, mentor, 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.
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.
Job Requirements:
Minimum requirement is a Bachelor of Science degree in a scientific discipline with 8 years of quality management experience plus at least 5 years’ experience serving in a relevant technical management capacity required. A Master’s degree with 6 years or a PhD with 4 years of quality experience would be considered. At least 15 years of regulated pharmaceutical industry experience. 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
Support attainment of aggressive growth and profit objectives by ensuring adherence to Quality Systems as required by various regulatory bodies
Demonstrated level of respect for individuals
High level of integrity and personal responsibility
Record of innovation
Experience developing, implementing, and executing strategic plans and objectives for organizations and departments
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Vice President of Quality, Quality Site Head at a contract manufacturer of microbial fermentation and/or mammalian cell culture protein therapeutics. Lead a Quality Assurance and Quality Control team which includes both QC Analytical and QC Microbiology. The individual in this role is recognized as a subject matter expert with regard to Quality Assurance and Quality Control.
Quality Assurance:
The Vice President of Quality, Quality Site Head is accountable for raw material release, Quality on the floor, disposition of drug substance, QA review of quality control data, root cause analysis, risk management, deviation, Change Control and CAPA management, document/records management, quality metrics reporting, data integrity, training management, QA review of method qualification/validation, process qualification/validation, and equipment/utilities/facilities qualification and continuous improvement. Partner with Global Quality in ensuring internal audits, client audits, supplier quality management, managing regulatory inspections, and quality systems are implemented effectively, efficiently, and compliantly at the site.
Quality Control:
The Vice President of Quality, Quality Site Head is accountable for QC Analytical and QC Microbiology. He/she is responsible for oversight of QC Analytical testing and QC Microbiology tasks including Bioburden, Endotoxin, TOC Conductivity, Water collection Osmolality, EM collection and testing, Organism/Media QC, EM Trending, Sample Accessioning, and Raw Material Program Management.
Proven skills in the knowledge of 21CFR210, 211 is also required. This role is key in collaborating with site operations (Manufacturing, Facilities & Engineering, Supply Chain, EHS&S, and Operational Excellence) to ensure appropriate quality oversight. Partnership with the Senior VP, Operations, and Site Head is crucial to ensure the site’s success.
In consultation with the SVP of Quality and Regulatory, the Vice President of Quality, Quality Site Head holds final accountability for and decision making on the matters relating to GMP compliance for the site.
Job Responsibilities:
Oversee and implement quality systems, standards, and procedures for inspecting, testing, and evaluating manufactured product. Ensure the site is inspection ready at all times. Collaborates with other Quality Site Heads on continuous improvement initiatives.
Lead, assess, mentor, 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.
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.
Job Requirements:
Minimum requirement is a Bachelor of Science degree in a scientific discipline with 8 years of quality management experience plus at least 5 years’ experience serving in a relevant technical management capacity required. A Master’s degree with 6 years or a PhD with 4 years of quality experience would be considered. At least 15 years of regulated pharmaceutical industry experience. 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
Support attainment of aggressive growth and profit objectives by ensuring adherence to Quality Systems as required by various regulatory bodies
Demonstrated level of respect for individuals
High level of integrity and personal responsibility
Record of innovation
Experience developing, implementing, and executing strategic plans and objectives for organizations and departments
#J-18808-Ljbffr