Director, Quality Assurance - Analytical

This individual will lead and direct 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.

• Leads and directs the Quality Assurance team supporting Analytical testing operations.
• 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.
• Supports GMP testing activities including release and stability testing.
• Overseas QA review of method qualifications, transfer and validations.
• 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.

Experience:

• 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.
• Experience reviewing Analytical Test Methods required.
• Biopharmaceutical manufacturing operations experience required.

Language Ability:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Salary: $165,000 - 195,000
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.