Manager, Manufacturing Compliance Coordinator (FBF)

  The Manager, Manufacturing Compliance Coordination (FBF) is responsible for all manufacturing CAPAs, change controls and deviations. This includes the leading of all manufacturing deviation investigations through to completion, support of all internal and external audits and collaboration with cross functional groups including Quality Assurance to support ‘on-time' release and disposition of batches and other post-execution activities.

External US

Essential Functions:

• Oversee and provide leadership to the Compliance Coordination team
• Assist in organizing, managing and improving the activities of the Compliance Coordination team, which consist of Deviation Coordinators and Compliance Coordinators
• Support to achieve 100% on-time closure of all quality related investigations
• Own all deviation, CAPA, and change control closure for Manufacturing
• Own all Root Cause Analysis Investigations
• Own all Problem Analysis (PA) events
• Owns all After Action Reviews (AAR)
• Drives continuous improvement of batch related documentation
• Work collaboratively with site management to instill a ‘Quality Culture' by coaching Manufacturing staff in the application of cGMP Principles including the underlying rationale of those principles
• Support the Quality and Manufacturing organization during internal and external audits (client audits, regulatory inspections, etc)
• Support the external and internal Audit Programs to be in an acceptable state of compliance
• Work with Quality management to implement quality systems that will enable cGMP manufacturing of pre-clinical to commercial products
• Responsible for Manufacturing audit preparations, conducting internal, external and regulatory audits
• Coordinate batch and formulation record review and corrections to executed records
• Coordinate the initiation of new deviations
• Schedule and facilitate post manufacturing campaign lessons learned
• Leads the completion of periodic reviews
• Provides and maintains metrics around batch closure, including deviation, CAPA and change control status

Required Skills & Abilities:

• Must have a working knowledge of cGMP regulations associated to production of biologic drug products.
• Excellent oral and written communication skills, interpersonal and organizational skills.
• Excellent organizational, analytical, data review and report writing skills.
• Thorough understanding of all aspects related to cGMP manufacturing.
• Thorough understanding of Single-Use Technology used in bioprocessing (downstream and/or upstream).
• Thorough understanding of closure requirements associated with closed system processing
• Proficient user of deviation management systems such as TrackWise
• Proficient user of quality document control systems such as MasterControl
• Proficient with Microsoft Office applications
• Good self-discipline and attention to detail
• Must have flexible work hours – must be willing to work outside of normally-scheduled hours as necessary; including opportunities for alternative shift-hours and weekends as required
• Ability to multitask and easily prioritize work
• Ability to work independently with little supervision
• Ability to supervise/manage a team to achieve team objectives
• Must have good planning skills and must be willing to interface colleagues across all levels of the FDB network

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.
• Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
• Attendance is mandatory.

Qualifications:

• Bachelor's degree in Science, Engineering or other related field and 6 years of relevant experience; 4 of which should be in manufacturing; OR
• Associate degree in Science, Engineering or other related field and 8 years of relevant experience; 5 of which should be in manufacturing; OR
• High School diploma/GED with 10 years of relevant experience; 6 of which should be in manufacturing; with
• Above experience must include four (4) years' managerial experience.
• cGMP experience required

Preferred Qualifications:

• Experience with cell culture and purification processes.
• Lean Six Sigma – Green Belt or higher
• Experience working in a cGMP environment with exposure to good documentation practices.

We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. 

If an accommodation to the application process is needed, please e-mail FDBTHR@fujifilm.com or call 979-431-3500.

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