Sr. Director, Quality - KBI Biopharma : Job Details

Senior Director 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 AssuranceThe Senior Director 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 ControlThe Senior Director 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.

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 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 Requirements: 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.

Key Areas of Expertise:

• 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

Must Have:

• Ability to read, analyze, and interpret complex documents.
• Ability to respond effectively to sensitive inquiries or complaints.
• Ability to write speeches and articles using innovative techniques or style.
• Ability to make effective and persuasive speeches and presentations on complex topics.
• Ability to apply principles of logical or scientific thinking to a wide range of problems.
• Ability to understand and interpret nonverbal symbolism in its most difficult phases.
• Ability to deal with a variety of abstract and concrete variables.
• Ability to apply advanced mathematical concepts.
• Ability to apply mathematical operations to various tasks.
• Ability to sit or stand for long periods of time.
• Ability to use a computer and relevant software.

Range: $205,000.00 / yr - $282,700.00 / yr

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 workforce. 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.