Job Summary:

The MQA Manager/Sr. Manager is responsible for supervising the MQA team who supports the Manufacturing Process and Areas as part of a GMP Contract Manufacturing Organization. MQA Manager/Sr. Managers are expected to provide sound guidance to internal MQA team and customers with respect to process, SISPQ of product, and risk. The MQA Manager/Sr. Manager’s team shares responsibility for the inspection readiness of the site. MQA Manager/Sr. Manager routinely work on the cleanroom floor directly with the MQA and Manufacturing team to provide real time guidance and support. The Manager/Sr. Manager must adhere to procedures and policies to work on the Manufacturing floor. MQA Manager/Sr. Manager routinely collaborates with Manufacturing and work on team initiatives. The MQA Manager/Sr. Manager is responsible for coaching and mentoring their teams as needed to foster a GMP compliant site.

Job Responsibilities:

• Lead, assess, mentor, and develop departmental associates. Level load work across team to ensure timely review/approval of Quality items in support of manufacturing and batch release timelines. 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. Coach QA Specialists to achieve proficiency for the process execution, reviewing/approving executed process records SOPs, DTRs and Deviations.
• Manage the process proficiency for the site. Oversee MQA support of Manufacturing. Work directly with functional areas to review and approve process procedures. Report KPI’s and collaborate with functional areas to improve the Site Quality Systems and streamline processes.
• Coordinate client communications for batch record comment resolution. Address client comments with internal SMEs and driving client approvals. Represent Quality in required client meetings, which includes obtaining client metrics and presenting in client meetings.
• Attend relevant operational meetings in support of Manufacturing Operations and disposition activities.
• Support Client Audits and Regulatory Inspections as required.

Minimum Requirements:

Knowledge, Skills, Abilities

• BS and 10+ years’ experience (Manager), MS and 8+ years’ experience (Sr Manager) in a QA or cGMP environment in Biopharmaceuticals or equivalent.
• Experience in providing Quality guidance to manufacturing to include Deviations/CAPAs and Change Controls, with 4+ years of supervisory experience.
• Demonstrates strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem resolution skills.
• Strong understanding of FDA, EU, and ROW cGMP regulations.
• Experience and knowledge of worldwide regulatory requirements with emphasis on regulatory requirements for biotechnology-derived product.

• Experience managing data, metrics, and presenting to senior management.
• Demonstrate strong interpersonal skills, ability to work in a team environment, attention to details, and excellent problem resolution skills.
• Demonstrated track record in the following key areas:

- Strong orientation for 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.

Language Ability

• Ability to read, analyze, and interpret English documents.
• Ability to respond effectively to the most sensitive inquiries or complaints.
• Ability to write technical correspondence that is easy to follow and understand.
• Ability to make effective and persuasive presentations on controversial or complex topics to senior management peer group, employee groups, and customers.

Reasoning Ability

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Math Ability

• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
• Ability to deal with a variety of abstract and concrete variables in situations where only limited standardization exists.

Physical Demands

• Use of hands and fingers to manipulate office equipment is required. Position may require sitting or standing for long hours of time.
• Support manufacturing and warehouse operations to include movement, gowning, and/or lifting

Computer Skills

• Proficient in Microsoft Excel, Microsoft Word, Outlook, PowerPoint, and Internet.
• Ability to use enterprise software, such as Document Management Systems, Learning Management Systems, Asset Management Systems, Electronic Lab Notebooks, Enterprise Resource Planning systems or similar programs.

Equipment Use

• Knowledge of and experience using a Computer, Telephone, Copier, Printer, Scanner

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.