Director, Quality Assurance - Analytical

Position Summary:

Leads and directs all QA activities supporting analytical laboratory operations in a contract manufacturing organization. Responsible for review of certificates of analysis for both clinical and commercial programs. Works directly with Biopharmaceutical Development to resolve lab investigations and other compliance issues in a timely manner. Communicates directly with clients to resolve issues related to GMP testing. Cultivate and maintain Quality Assurance staff by recruiting, training, and managing QA team members. Align QA organization to meet companies’ strategic goals. Experience managing a QA organization in both clinical and commercial operations is beneficial.

Position Responsibilities:

Leads and directs the Quality Assurance team supporting Analytical testing operations.

Lead, assess, coach, and develop departmental associates. Manage performance; ensure team meets expectations and meet objectives; guide the professional growth of team members by providing personal guidance and training relative to responsibilities.
Overseas QA review of method qualifications, transfer and validations. Supports GMP testing activities including release and stability testing.
Overseas QA review review of deviations, lab investigations, and GMP technical documents. Works directly with Biopharmaceutical Development group to resolve deviations and other compliance issues in a timely manner.
Communicates directly with clients to resolve issues related to GMP testing.

Minimum Requirements:

• Minimum BS and 12+ year experience or MS and 10+ years’ experience in a QA or GMP environment or equivalent.
• Leadership experience in a QA organization for clinical and commercial operations required
• Experience reviewing Analytical Test Methods required.
• Biopharmaceutical manufacturing operations experience required
• Ability to read, analyze, and interpret complex documents.
• Ability to respond effectively to sensitive inquiries or complaints.
• Ability to make effective and persuasive presentations on complex topics to senior management peer group, employee groups, customers and/or the boards of directors.
• 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, etc.,).
• Ability to deal with a variety of abstract and concrete variables.
• 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.
• Ability to use computer and equipment - (Word processing, Spreadsheets, Power Point, Internet, E-mail, Calendar Management, telephone)

Salary: $173,000 - $238,700

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.