Quality Site Head at a contract manufacturer of mammalian cell culture protein therapeutics. 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.
• 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.
  

Minimum requirements:

• 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.
• At least 5 years' experience serving in a relevant technical management capacity required.
• Must have thorough knowledge of cGMPs and biotechnology-derived product regulations.
• CMO experience preferred.

A demonstrated track record in the following key areas is required:

• 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.

Salary Range: $220,000 - $265,000

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.

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.