Germer International - Pharmaceutical Recruiting · 2 days ago
Senior Manager Quality External Supply
Allentown, PA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$125K/yr - $155K/yr
14+ years expGermer International is a recruiting firm specializing in the pharmaceutical industry, and they are seeking a Senior Manager for Quality External Supply. The role involves overseeing quality standards, managing audits, and ensuring compliance with regulatory requirements in external manufacturing operations.
BiotechnologyPharmaceuticalRecruitingStaffing Agency
Hiring Manager
Jessica Gerber
Responsibilities
Demonstrate strong knowledge of cGMPs, applicable GxPs, and pharmaceutical distribution processes
Perform routine quality audits of CMOs, including follow-up and timely closure of CAPA actions
Establish and maintain quality standards aligned with current regulatory requirements and PCC management expectations
Ensure implementation of the Quality Policy, Quality Management System (QMS), SOPs, and GMP regulations across External Supply and satellite Quality operations
Lead and/or support meetings with external manufacturing organizations to review manufacturing status, complaints, and non-conformances
Manage internal and external change controls, including impact assessments and approvals
Coordinate technically with cross-functional teams to expedite resolution of complaints, deviations, change controls, and investigations
Prepare, review, and maintain quality documentation, including Quality Agreements
Manage non-conformance and complaint investigations at external sites, including initiation and tracking within internal systems
Support changes to specifications, processes, or procedures at external sites, including initiation of internal tracking documents, assignment of action items, and project closure
Provide final product disposition, including review of externally generated batch records and analytical testing results
Manage stability programs for externally manufactured products, including review and evaluation of stability data
Review and/or approve Annual Product Quality Review (APQR) documents for externally manufactured products and support Regulatory Affairs with Annual Reports
Conduct internal audits and participate in regulatory audit preparation, including CAPA development and ensuring timely CAPA closure
Review and approve artwork and labeling, ensuring only current, approved versions are used
Lead supplier qualification and approval, including audit planning, execution, documentation, and tracking of audit findings to closure
Support CMOs and internal functions (Supply Chain, Technical Operations, Regulatory Affairs) in process validation, API qualification, and related activities
Support Business Development and Sales for product launches in new markets by ensuring timely quality deliverables and effective CMO communication
Represent Quality Assurance in CMO-related projects, including technology transfers, providing guidance on quality requirements and reviewing transfer protocols and reports
Support CMO Quality Operations activities, including SOP development, document management, training, and implementation
Contribute to new quality initiatives and support development of long-term quality strategy
Qualification
Required
14-16 years working experience in a regulated Pharmaceutical Company in GMP environment
Hands on experience of quality systems in a GxP environment, and direct experience with USFDA and other health authority inspections
A minimum of (5) years of experience in overseeing quality operations for sterile and aseptically manufactured pharmaceutical products
Company
Germer International - Pharmaceutical Recruiting
Welcome to Germer International! We're a Life Sciences search & placement firm that focuses on building long-term partnerships with small and mid-sized companies across the country.
11-50 employees
Funding
Current Stage
Early StageRecent News
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