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Senior Manager, GMP Quality Operations

Connexion Systems + Engineering

Remote, USA, MA(remote)

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JOB DETAILS
SALARY
$85–$100 Per Hour
SKILLS
Analysis Skills, Auditing, Biology, Biotech and Pharmaceutical, Change Control, Communication Skills, Compensation and Benefits, Computer Systems, Consulting, Continuous Improvement, Cross-Functional, Document Management, Documentation, Drug Development, Drug Manufacturing, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), GxP, Leadership, Maintain Compliance, Manufacturing, Manufacturing Operations, Manufacturing Systems, Matrix Management, Medical Products, Metrics, Operational Improvement, Operational Strategy, Operational Support, Operations Processes, Performance Metrics, Problem Solving Skills, Process Analysis, Process Improvement, Product Lifecycle, Quality Assurance, Quality Control, Quality Management, Regulations, Risk Management, Root Cause Analysis, Six Sigma, Six Sigma DMAIC, Standard Operating Procedures (SOP), System Operations, System Validation, Systems Engineering, Training Program, Trend Analysis, Workflow Analysis
LOCATION
Remote, USA, MA
POSTED
8 days ago
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

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!

About the Company

C

Connexion Systems + Engineering

Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity.  Over the last 20 years Connexion has built the most admired team of staffing experts in the industry.  We give back, change lives and offer unconditional support to the candidates we represent.

Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.

Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1999
WEBSITE
https://www.csetalent.com/