Senior Manager/Associate Director Manufacturing Compliance

Summary:

Sr. Manager/Associate Director of Manufacturing Compliance position is

strategically intended to support continuous improvement by developing and leading a team of Investigators in analyzing cross-functional non-conformances (deviations), defining root cause, assessing product impact, and implementing corrective/preventative actions. The MFG Compliance Sr. Manager/Associate Director should possess proven technical writing and problem-solving skills as well as a desire for developing investigators in the art of problem-solving analysis. This is a direct supervisor position also responsible for the training and development of the investigators as well as for their overall performance. An understanding of Biotechnology Upstream, Downstream, and Support principles with experience in non-conformance management is ideal.

Description:

• The Sr. Manager/Associate Director, Manufacturing Compliance is responsible for oversight of the Manufacturing Operations’ deviation performance. As a stakeholder, the incumbent will lead Site Deviation Triage meetings, as scheduled, in conjunction with Quality Assurance. The incumbent is responsible for the post-Triage assignment of the deviations to support Manufacturing Operations, ensuring departmental deviation ownership is balanced and appropriately distributed to facilitate timely and quality closure.
• Routinely analyze and present the health of the KBI Durham Manufacturing Deviation and CAPA performance to Management team for transparency and drive accountability for non-conformance closure and escalation of adverse trends.
• Train and mentor a team of investigators to conduct comprehensive investigations to determine root cause, product impact and implement corrective and preventive actions.
• Methodically investigation and troubleshoot Manufacturing non-conformances using defined troubleshoot and investigational techniques. Develop and implement preventive actions to reduce the potential of recurrence or proactively prevent the occurrence of a new deviation.
• Ensure non-conformance investigations meet or exceed the rigor of internal, client and regulatory reviewers.
• Collaborate with MFG Compliance Management to develop Deviation and CAPA training curriculum for development of MFG Compliance Specialists.
  
  
  

What you will do:

• Manage, Train and Mentor a team of investigators to conduct comprehensive investigations to determine root cause, product impact and implement corrective and preventive actions. Coordinate in achieving department goals by meeting or exceeding productivity, quality, and capacity objectives.
• Lead complex investigations and situation analyses. Methodically investigate and troubleshoot Manufacturing non-conformances using defined troubleshooting and investigational techniques. Gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on manufactured product, as well as the risk to future operations. Exercises judgement in developing practices, techniques, and evaluation criteria for obtaining results. Product high-quality documentation that meets applicable standards and is appropriate for its intended audience.
• Provide oversight of the Manufacturing Operations Deviation and CAPA performance (Metrics). Routinely analyze and present the health of the KBI Manufacturing Deviation and CAPA performance to Management team.
  
  
  

Requirements:

BA / BS Degree in a science field preferred (i.e., Biology, Microbiology, Chemistry, Pharmacy, etc.) or equivalent combination of education and experience; 10+ years of pharmaceutical or related work experience with emphasis on current Good Manufacturing Practices including QA, QC, Validation, Manufacturing, or Process Engineering.

Language Ability

Ability to read and interpret English language documents such as safety rules, standard operating procedures, operating and maintenance instructions, procedure manuals, batch, and production records. Ability to write routine and investigation reports and correspondence. Ability to speak effectively before internal groups or employees of the organization. Good deductive and inductive critical thinking skills required.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variable in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Strong time management skills and an ability to multitask in a fast-paced environment. Ability to deliver high-quality documentation, paying attention to detail. Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures.

Math Ability

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

Salary Range: $132,318 - $198,476

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.