Associate Quality Manager CMO provides oversight for the Quality Assurance for the CMO manufacturing site(s).
This would include Batch manufacturing processes, CMO Quality Systems such as change control process, documentation processes, CAPA, Risk Management and QA Validation oversight.
This position may also be cross trained to cover other QA functions as needed.
Provides support, direction and coaching to employees in the areas cGMP compliance, as needed
Assists with preparation of CMO’s FDA and other regulatory agency audits and inspections.
Prioritizes work in alignment with company priorities.
Ensure that Good Manufacturing Practice (GMP) at CMO organization(s).
Gives guidance and support to CMO site(s) on data integrity and Good Documentation Practices, as needed.
Support CMO manufacturing by overseeing all work activities for Documentation Management, Change Control, CAPA process, Quality Risk Management, and Validation Department.
Supports external audits for CMO sites.
Escalates critical quality problems to Senior Management in a timely manner.
This Quality role will be responsible for supporting the external QA leader's oversight of CMO’s which supply clinical and commercial product(s) to Immunomedics for market globally
Write and Implement SOPs at Immunomedics consistent with Immunomedics global systems regarding CMOs
Oversee CMO’s to ensure products manufactured for Immunomedics are produced in accordance with GMP, regulatory requirements, and Immunomedics requirements
Participate in Quality review meetings with CMOs, track Quality metrics, identify risk areas and propose CAPAs to resolve Quality matters with external partners
Conduct batch record review and release, change control review and approval, process and analytical investigations, product complaints, support Annual Product Reviews, CAPA follow up etc. related to products manufactured at CMOs in compliance with Immunomedics requirements
Review Quality Agreements, ensure Quality Agreements are implemented where required, and ensure compliance with the requirements of the Quality Agreements
Quality Person in Plant for manufacturing operations expected
Assistance in inspection readiness as required for CMO
BS in Life Sciences, Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company.
QA hands-on QA experience ideally in CMO Quality oversight. Must be fluent in English.
Additional technical experience in an area allied with cGMP Quality, Phased approach to Quality Systems, Biopharma Production Processes, 21CFR 210-211, ICH guidelines, FDA Guidance for Industry for Investigating OOS Results, Deviations, CAPAs, Validation, Stability Studies, QC laboratory operations and manufacturing operations, auditing is preferred.
Strong understanding of pharmaceutical manufacturing processes for antibody drug conjugates, or biologics and/or small molecules
Experience in manufacturing batch record review leading to lot release
Experience with CMO management is necessary
Excellent verbal and written communication skills, organizational and time management skills; strong attention to detail
Strong EQ and project management skills
Travel 60% national and international
Home base flexible – virtual team member skills advantageous
Ability to coordinate Quality oversight and in working with other site group.
Ability to review Quality documents and ensure compliance to GMP. Documents to include batch records, logs, and others.
Ability to write Quality documents such as SOPs, protocols, and others to ensure compliance with process and GMPs.
Ability to review and apply release requirements raw materials and components for cGMP use.
Ability to effectively communicate to Management, and line staff.
Ability to train site staff on Quality aspects and GMPs.
Ability to recruit, train, develop, support and motivate personnel.
Must be very detail oriented and be able to quickly detect errors within documentation.
Ability to work with other manufacturing teams to implement business objectives.