Director, Manufacturing Quality Assurance

• Monitors and evaluates the effectiveness of corporate compliance programs and implements change, as required, to ensure compliance to cGMP requirements. Responsible for the overall direction, coordination and evaluation of Quality Systems.

• Provides overall direction to a QA department responsible for product release, QA on the floor in manufacturing, review and resolution of deviations, QA Materials review, and QA review of QC and stability testing.

• Review, identify, prioritize and implement or coordinate change improvement to technology, people and/or processes to assure compliance with regulatory and organization policies/procedures and to maximize process efficiency and conformance.

• 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.

• Responsible for assuring that departmental employees comply with required

• procedures; responsible for ensuring that all departmental employees attend

• and participate in safety training and programs.

• Interacts with clients to resolve Quality issues.

• Able to react to change productively and handle other essential tasks as assigned.

Requirements:

• Bachelor degree in pharmaceutical science, biology, chemistry, engineering or related science. 10 years work experience in pharmaceuticals and/or biologics manufacturing in a Quality Assurance role; with at least 3 years of supervisory experience.

• Requires thorough knowledge of GMP guidelines as they relate to all aspects of quality systems and compliance.

• Experience with FDA, EMA and knowledge of regulatory requirements with emphasis on regulatory requirements for biotechnology-derived product.

Also requires a demonstrated track record in the following key areas:

• Strong Quality and Customer Service

• Demonstrated level of respect for individuals

• High level of integrity and personal responsibility

• Record of innovation

• Strong collaboration and team building skills

Salary Range: $168,308 - $231,424

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.