Job Description
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Title:
Senior Manager, GMP Quality Operations Hiring Organization:
Connexion Systems & Engineering Compensation, Benefits, and Employment Type Duration:
6+ month contract, potential for extension or conversion Pay rate: $85-$100/hr Job Location:
Remote, USA Schedule:
M-F, EST
time zone working hours Job#: bh19116 Description:
A rapidly growing clinical-stage biopharmaceutical organization is seeking a Senior Manager, GMP Quality Operations to provide strategic and operational leadership across GMP Quality and Quality Systems initiatives. This is a high-impact remote consulting opportunity supporting quality operations, training compliance, vendor oversight, process improvement initiatives, and Quality Management System (QMS) evolution in a regulated GxP environment. The ideal candidate will bring deep expertise in GMP quality operations within biologics or pharmaceutical manufacturing environments and demonstrate strong cross-functional leadership, operational excellence, and inspection-readiness experience. Key Responsibilities GMP Quality & Quality Systems Operations Provide operational quality oversight supporting manufacturing operations, batch record review, and batch disposition activities for clinical and commercial products Partner on investigations, deviations, CAPAs, change controls, OOS events, and non-conformances Facilitate root cause analysis and continuous improvement activities using structured problem-solving methodologies Draft, revise, review, and approve SOPs and other controlled GMP documentation Collaborate cross-functionally with Manufacturing, Quality Systems, Validation, Regulatory, and external partners Identify quality trends, compliance risks, and improvement opportunities across operations Support oversight of Computer System Validation (CSV) activities and vendor coordination Ensure compliant implementation and assessment of process changes impacting product disposition and manufacturing operations Support inspection readiness and broader Quality operational initiatives as assigned by leadership Training & Quality Compliance Lead and enhance GMP training initiatives and training compliance programs Monitor and manage training KPIs and compliance metrics Identify and implement improvements to training systems, workflows, and learning effectiveness Partner with business stakeholders to ensure appropriate role-based training and learning activities are implemented Quality Projects & Systems Enhancement Support redesign and continuous improvement of the training management program Lead or support audit management and oversight initiatives Drive Veeva Quality Suite enhancement initiatives and process optimization efforts Establish and maintain quality management KPIs, escalation processes, and operational tracking tools Process Improvement & Documentation Identify workflow inefficiencies and implement process improvement solutions Support development and continuous improvement of SOPs, templates, and work instructions Proactively identify compliance gaps, operational risks, and mitigation strategies Participate in operational excellence and cross-functional improvement initiatives Qualifications Bachelor's degree in Life Sciences or related scientific discipline 7-10+ years of experience in QA, QMS, QC, or Manufacturing within an FDA-regulated pharmaceutical or biotechnology environment Strong GMP Quality Operations and Quality Systems experience, preferably supporting biologics or therapeutics Experience across the product lifecycle from clinical development through commercialization Direct regulatory interaction experience including inspections, submissions, or health authority support activities Experience leading continuous improvement initiatives using methodologies such as: Root Cause Analysis LEAN DMAIC
Six Sigma Demonstrated expertise with: CAPAs Deviations Change Controls Audit Management Training Compliance CSV oversight Strong working knowledge of Veeva Quality Suite Excellent communication, stakeholder management, and matrix leadership skills Proven ability to influence cross-functional teams and drive a culture of quality and operational excellence Strong analytical, problem-solving, and decision-making capabilities Ideal Candidate This role is ideal for a senior-level GMP Quality professional who thrives in fast-paced biotech environments and enjoys balancing strategic quality initiatives with hands-on operational execution. Candidates with experience driving inspection readiness, training transformation initiatives, and quality systems optimization in emerging or clinical-stage organizations are strongly encouraged to apply. Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly. You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line. If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com . We would be glad to help you find the perfect job!
