GMP Operational Quality Senior Manager

** Job Description
**** General/Position Summary
** Senior Manager, GMP Quality Operations is a technical resource in the principles and application of quality assurance and compliance. The Sr. Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects. The role is responsible for maintaining documents reconciliation, labeling control, master batch records and issuance of batch records for production.  

The quality senior manager is responsible for implementing strict issuance tracking, controlling version updates, and ensuring data integrity (ALCOA+) to prevent unauthorized changes and ensure product safety

The role will closely partner with operational stakeholders to lead product disposition activities and resolution.  A key expectation is the ability to closely collaborate and build relationships with internal and external stakeholders for advancing quality outcomes and operational excellence.
** Key

Duties & Responsibilities
*** Author SOP's to support commercial quality functions.
* Assist with regulatory agency inspections
* Ensuring that Master Batch Records are managed to maintain compliance over the life cycle.
* Identify and facilitate continuous improvement efforts
* Managing the issuance of BPRs, ensuring only authorized, current versions are printed for production.
* Maintaining logs for the issuance, return, and reconciliation of batch records to prevent misuse and ensure accountability.
* Ensure audit readiness:
Maintaining organized, accessible documentation for regulatory inspections
* Establishment of quality oversight for internal quality and external CDMO operations for the batch disposition process, across development, launch and commercial manufacturing.
* Manage the day-to-day timely release of finished product to ensure compliance with Regulatory and Vertex cGMP requirements.
* Assure disposition activities across CGT Therapy related products manufacturing are compliant and consistent.
* Develop, establish, and implement Batch disposition operational Quality and Compliance metrics.
* Act as the batch disposition subject matter expert (SME) in support of regulatory inspections and audits, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
* Identify and communicate risks and assist with risk mitigation plans as necessary.
* Represent Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning.
* Participate and lead GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.
* Lead and mentor other team members, support development of organizational capabilities and talent building.
* Manage the department resources with regards to budget and personnel.
* Build strategic relationships with internal and external partners – CDMOs within the Quality organization to ensure Quality issues are raised and addressed, as necessary.
** Required Education Level
*** Bachelor's degree or Masters degree relevant comparable background.
** Required Experience
** 8+ years of experience and 5+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment
** Required Knowledge/Skills
*** In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (EU GMPs, FDA 21

CFR Part 1271, GxPs).
* Broad and current knowledge of batch disposition industry trends and best practices in Cell/Gene therapies.
* Preferred QA Operational experience for Autologous Cell Therapy Operations.
* Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
* Demonstrated strategic planning and execution skills required for operational effectiveness and compliance. Proven ability with Root Cause Analysis, data analytics, and…