Location: Durham,NC, USA
Overview
The QA Disposition Manager is responsible for the day-to-day cGMP compliance and QA activities that encompass the disposition of both clinical and commercial manufactured products, ensuring the products have been produced and analyzed in accordance with FDB procedures and the relevant GMP regulations. The QA Dispositoin Manager organizes and maintains status of program details, enabling rapid communication. The QA Disposition Manager serves as the FDBU QA point of contact for Customers, leading/particpating in Integrated Program Teams (IPT), Problem Analysis teams, and preparing for JSC discussions, throughout the assigned program lifecycle. The individual must be able to timely identify, solve and/or escalate compliance concerns and partner cross-functionally, using problem solving skills to continously improve the quality systems. The QA Disposition Manager must be able to provide quality and compliance leadership to meet the dynamic needs of our Customer programs, being adept with resolution of complex cGMP decisions, internally and with external partners. The QA Disposition Manager maintains confidentiality while working with multiple programs for Customer notifications and issuance of documents.
External US
MAJOR ACTIVITIES AND RESPONSIBILITIES:
* Dispostion manufactured materials, ensuring compliance and patient safety.
* Determine batch impact and analysis from deviations, change controls, supplemental test results and facility, EM and utlitily conditions as part of contextual review.
* Performs pre-production activities, including review/approval of Master Batch Records, Batch Material Masters in SAP, Sampling Plan, item specifications and other document.
* Coordinate and lead MRB process, participate in Customer audits and inspections, participates in the PQR process.
* Implement the quality requirements documented in Quality Agreements.
* Reviews/approves deviations with potential batch impact, ensuring the associated investigations are complete, clear and written to support Customer and Regulatory acceptance.
* Manages Customer complaints to conclusion.
* Provides timely communication and responses to both internal and external Customers for product related deliverables.
* Delivers high throughput, high quality and Right First time actions.
BACKGROUND REQUIREMENTS:
Required Skills/Education:
* BS/BA in Life Sciences or equivalent with 6+ years of applicable industry experience
* 3+ years in GMP Quality Assurance or similar role
* Experience in cGMP manufacturing, Validation and/or Quality oversight in an FDA regulated faciltiy
* Previous experience with dispositon of biotechnology maufactured API or DPs
Desired Skills:
* MS in Life Sciences or equivalent and 5+ years of applicable industry experience
* Working knowledge of SAP, TrackWise, MasterControl and/or other GMP software programs
* Experience working in a contract manufacturing organization
Physical Demands:
Sitting 50-90%, Standing and walking: 10-50%, lifting u to 25 pounds (document boxes). Ability to use PPE for Manufacturing, warehouse and laboratories.
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 - 130 and Export Administration Regulations in 15 C.F.R. Part 730 - 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.
FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please e-mail ...@fujifilm.com.
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.